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Endoscopic balloon sphincter dilation (sphincteroplasty) versus sphincterotomy for common bile duct stones

Endoscopic balloon dilation was introduced as an alternative to endoscopic sphincterotomy to preserve the sphincter of Oddi and avoid undesirable effects due to an incompetent sphincter. Endoscopic balloon dilation has been largely abandoned by USA endoscopists due to increased risks of pancreatitis noted in one multicentre trial, but is still practiced in parts of Asia and Europe.

To assess the beneficial and harmful effects of endoscopic balloon dilation versus endoscopic sphincterotomy in the management of common bile duct stones.

We searched The Cochrane Hepato‐Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, and EMBASE until January 2004. We hand searched Gastrointestinal Endoscopy (1983 to 2002), read through bibliographies of all included randomised clinical trials, and contacted all primary authors regarding missed randomised trials.

Randomised clinical trials comparing endoscopic balloon dilation versus endoscopic sphincterotomy in removal of common bile duct stones irrespective of publication status, language, or blinding.

Data collection was done by two independent authors for decisions on study inclusion, data abstraction, and quality assessment. When there was a non‐resolvable discrepancy, the third author made the final decision. Analysis was run with RevMan Analysis.

Fifteen randomised trials met our inclusion criteria (1768 participants). Less than half of the trials reported adequate methods of randomisation and only two trials used blinded outcome assessment. Endoscopic balloon dilation is statistically less successful for stone removal (relative risk (RR) 0.90, 95% confidence interval (CI) 0.84 to 0.97, random‐effects), requires higher rates of mechanical lithotripsy (RR 1.34, 95% CI 1.08 to 1.66, random‐effects), and carries a higher risk of pancreatitis (RR 1.98, 95 CI 1.35 to 2.90, fixed‐effect). Conversely, endoscopic balloon dilation has statistically significant lower rates of bleeding. Endoscopic balloon dilation leads to significantly less short‐term infection and long‐term infection. There was no statistically significant difference with regards to mortality, perforation, or total short‐term complications between endoscopic balloon dilation and endoscopic sphincterotomy.

Endoscopic balloon dilation is slightly less successful than endoscopic sphincterotomy in stone extraction and more risky regarding pancreatitis. However, endoscopic balloon dilation seems to have a clinical role in patients who have coagulopathy, who are at risk for infection, and possibly in those who are older.

Endoscopic balloon dilation seems inferior to endoscopic sphincterotomy for common bile duct stone removal

Endoscopic balloon dilation is slightly less successful than endoscopic sphincterotomy in stone extraction and more risky in inducing pancreatitis. However, endoscopic balloon dilation seems to have a clinical role in patients who have a coagulopathy, who are at risk for infection, and possibly in those who are older.

Endoscopic sphincterotomy was originally introduced more than 30 years ago for elderly and frail patients unfit for surgery (Classen 1974). Over the last two decades endoscopic sphincterotomy has become the treatment of choice for stone extraction in a growing population of significantly younger and healthier patients. Despite its relative safety, endoscopic sphincterotomy is the most dangerous procedure performed by endoscopists with overall complication rates occurring in about 10% (Cotton 1991; Freeman 1996). As a result, the short‐term risks of pancreatitis, bleeding, perforation, and death, along with the potential long‐term complications of papillary stenosis and the danger of bacterial contamination of biliary system are important concerns (Bergman 1996).

Endoscopic balloon dilation was first proposed in 1983 by Staritz et al (Staritz 1983) as an alternative to endoscopic sphincterotomy with the hope of avoiding these short‐term and long‐term complications through preserving the sphincter of Oddi. As a therapeutic maneuver, endoscopic balloon dilation has been shown to be successful with ductal stone clearance rates of 80% to 100% in several case series (Groen 1989; May 1993; MacMathuna 1994; MacMathuna 1995; Bergman 1997b; Komatsu 1998a). However, many gastroenterologists are hesitant to accept endoscopic balloon dilation as an alternative to endoscopic sphincterotomy primarily for fears of an increased risk of pancreatitis.

Rates of pancreatitis in case series evaluating endoscopic balloon dilation for common bile duct stone removal range from 0% to 7% (Staritz 1983; Cotton 1991; May 1993; MacMathuna 1995; Gottlieb 1998; Komatsu 1998a) compared with reported rates of 0% to 39% in series evaluating endoscopic sphincterotomy for stone removal (Cotton 1991; Freeman 1996). While randomised clinical trials from Europe and Asia have demonstrated similar rates of pancreatitis between the endoscopic balloon dilation and endoscopic sphincterotomy groups (Minami 1995; Bergman 1997a; Cho 1998; Ochi 1999), one international multicenter trial noted a higher incidence of pancreatitis with two subsequent deaths in the endoscopic balloon dilation group (DiSario 1997; DiSario 1999). Although endoscopic balloon dilation is a popular alternative used for stone extraction in parts of Europe, Japan, and Korea (Sheth 2001), the majority of endoscopists in the US have abandoned its routine use mainly for fears of pancreatitis.

On the other hand endoscopic balloon dilation appears to have lower rates of bleeding and perforation. While endoscopic sphincterotomy involves cutting and carries bleeding rates of 2% to 5% (Cotton 1991; Freeman 1996), endoscopic balloon dilation theoretically preserves the biliary sphincter with reportedly no bleeding (Staritz 1983; Cotton 1991; MacMathuna 1995; Minami 1995; Freeman 1996; Bergman 1997a; DiSario 1997; Komatsu 1998a; DiSario 1999). Consequently, endoscopic balloon dilation has been shown to be safe even in patients with coagulopathies who normally carry a 6.6% to 14.3% mortality rate with endoscopic sphincterotomy (Moreira 1991; Sugiyama 1993; Freeman 1996; Kawabe 1996a; Komatsu 1998a). The risk of perforation also appears to be lower in endoscopic balloon dilation groups with reported rates in case series of 0% to 1% as compared with 1% to 2% in endoscopic sphincterotomy series (Cotton 1991; May 1993; MacMathuna 1995; Freeman 1996; Komatsu 1998a).

Because endoscopic balloon dilation is felt to have a lower incidence of bleeding, it is generally advocated as a safer alternative to endoscopic sphincterotomy in patients with atypical anatomy such as those with duodenal diverticulum or past Roux‐en‐Y or Billroth II operation. To date at least two trials involving patients with a history of a Billroth II procedure reported no complications of bleeding (Kalinsky 1999a; Bergman 2001b).

Since endoscopic balloon dilation has been demonstrated to preserve the sphincter of Oddi, the potential long‐term consequences of endoscopic sphincterotomy are theoretically avoided (Minami 1995). In retrospective studies reviewing patients 11 to 20 years after endoscopic sphincterotomy the noted long‐term complications include papillary stenosis, loss of sphincter of Oddi function, and bacterial contamination of the normally sterile biliary tree (Gregg 1985; Skar 1986; Hawes 1990; Sand 1992; Heinerman 1994; Sugiyama 1998; Tanaka 1998; Sheth 2001; Sugiyama 2002). This bacterial contamination may lead to recurrence of bile duct stones as a result of deconjugation of bilirubin by bacterial enzymes, inflammatory changes of the biliary system, recurrent ascending cholangitis, and a theorized potentially malignant degeneration (Goldman 1983; Greenfield 1985; Kurumado 1994; Maki 1966).

At the time this systematic review was started we were unable to identify meta‐analyses or systematic reviews on sphincteroplasty versus sphincterotomy for patients with common bile duct status. However, during the completion of this review a meta‐analysis was published in 2004 (Baron 2004).

To compare endoscopic balloon dilation (EBD) with endoscopic sphincterotomy (ES) in the management of common bile duct stones with regards to success with stone removal, short‐term complications (bleeding, perforation, and pancreatitis) and long‐term complications (strictures, recurrent stones, cholangitis, and cancer).

Randomised clinical trials comparing endoscopic balloon dilation versus endoscopic sphincterotomy in removal of common bile duct stones. We included trials irrespective of publication status (unpublished or published as an article, abstract, or a letter), language (no language limitations were applied), or blinding.

Patients with common bile duct stones noted on endoscopic retrograde cholangiopancreatography.

Endoscopic balloon dilation compared with endoscopic sphincterotomy with or without the aid of balloon extraction, basket extraction, mechanical lithotripsy, or endoscopic sonic lithotripsy for stone extraction.

Primary outcome measures 
 (1) Technical success divided into: 
 (1a) Ability to remove stone(s) with first attempt. 
 (1b) No evidence of stone recurrence in more than six months.

Primary adverse event outcomes 
 (2) Mortality: 
 (2a) Mortality within first 30 days of procedure. 
 (2b) Mortality at maximal follow‐up. 
 (3) Pancreatitis as defined by each trial. 
 (4) Bleeding as defined by each trial. 
 (5) Perforation as defined by each trial. 
 (6) Infection divided into: 
 (6a) Biliary tract infection. Evidence of fever or septicemia, leukocytosis, related to the biliary tract. 
 (6b) Non‐biliary tract infection. Evidence of fever or septicemia, leukocytosis, unrelated to the biliary tract. 
 (7) Total combined primary adverse events.

Secondary adverse event outcomes 
 (8) Transient sphincter obstruction: Defined as post procedure rise in liver transaminases with or without associated symptoms or known liver damage. 
 (9) Miscellaneous: 
 (9a) Pneumonia. 
 (9b) Adverse reaction to interventions. 
 (9c) Others as defined by each trial. 
 (10) Total of secondary adverse events. 
 (11) Total overall (primary and secondary) adverse events.

Other secondary outcomes 
 (12) Long‐term complications (greater than 30 days): 
 (12a) Papillary stenosis. 
 (12b) Recurrent ascending cholangitis. 
 (12c) Bile duct malignancy. 
 (12d) Others as defined by each trial. 
 (13) Cost as measured in US dollars.

Methodological quality 
 In addition to data abstracted from the trial manuscripts (Appendix 1), we recorded measures of trial quality. Due to the risk of overestimation of intervention effects in randomised trials with inadequate components (Schulz 1995; Moher 1998; Kjaergard 2001), we assessed the methodological quality by the four separate components, described below.

Generation of the allocation sequence 
 The procedure used to create a random sequence ensuring that each participant has a known, unpredictable, and usually equal chance of being assigned to intervention groups. The allocation sequence generation can be classified as:

• Adequate, if the allocation sequence was generated by a computer or random number table. Drawing of lots, tossing of a coin, shuffling of cards, or throwing dice may also be considered as adequate if a person who was not otherwise involved in the recruitment of participants performed the procedure;

• Unclear, if the trial was described as randomised, but the method used for the allocation sequence generation was not described;

• Inadequate, if a system involving dates, names, or admittance numbers were used for the allocation of patients. Such studies are known as quasi‐randomised studies and should usually be excluded from systematic reviews because they are associated with a considerable risk of bias.

Allocation concealment 
 The procedure used to conceal the allocation sequence from the investigators who assign participants to the intervention groups. The allocation concealment can be classified as:

• Adequate, if the allocation of patients involved a central independent unit, on‐site locked computer, identically appearing sealed envelopes. Envelopes should be serially numbered, sealed, and opaque. However, this information is rarely provided, indicating an increased risk of bias. In that case, sealed envelopes may constitute an intermediate category between adequate and unclear;

• Unclear, if the trial was described as randomised, but the method used to conceal the allocation was not described;

• Inadequate, if the allocation sequence was known to the investigators who assigned participants or if the study was quasi‐randomised.

Blinding (or masking) 
 The procedure used to keep trial participants, health care providers, and outcome assessors unaware of the intervention to which participants were assigned. Judicial assessors of outcomes, data analysts, data safety, monitoring committee members, and manuscript writers can also be blinded. In some cases, evaluation of whether outcome assessors were blinded may be sufficient. This primarily concerns trials on surgery or other procedures. Blinding can then be classified as:

• Adequate, if the trial was described as double blind and the method of blinding involved blinding of outcome assessors;

• Unclear, if the trial was described as double blind, but the method of blinding was not described;

• Not performed, if the trial was not double blind.

Follow‐up 
 The purpose of randomization is to generate comparable intervention groups. This baseline equivalence may be disrupted if participants are lost to follow up. To evaluate the risk of such attrition bias, we suggest that authors extract the number and reasons for dropouts and withdrawals. Extraction of this information can be difficult due to unclear reporting. It may therefore sometimes be relevant to extract the adequacy of follow‐up reports. The reported follow‐up can be classified as:

• Adequate, if the numbers and reasons for dropouts and withdrawals in all intervention groups were described or if it was specified that there were no dropouts or withdrawals;

• Unclear, if the report gave the impression that there had been no dropouts or withdrawals, but this was not specifically stated;

• Inadequate, if the number or reasons for dropouts and withdrawals were not described.

When trials did not clearly state that intention‐to‐treat analysis was used, attempts were made to collect data in an intention‐to‐treat manner from examination of the manuscript. If the data could not be clearly adjusted in this fashion, then the data were used as they were. In the best‐case scenario all authors would have provided clarification of all missing data and whether or not intention‐to‐treat methodologies were used. In a worst‐case scenario, when the use of intention‐to‐treat methodologies were not clear, the data abstractors had to make attempts to conform the data in such a way as to account for patient dropouts or missing data.

We searched The Cochrane Hepato‐Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, and EMBASE until January 2004. The search strategies used with the time span of the searches are given in Additional Table 1. We conducted hand searches in abstracts from meetings held from 1983 to the present by American Society for Gastrointestinal Endoscopy (ASGE). Bibliographies of all included trials were searched for references not found by our searches. Then attempts were made to locate abstracts and if necessary the full texts of all titles which appeared relevant. Attempts were made to contact all primary authors of included trials. They were sent a list of included trials, and asked about other randomised clinical trials that we may have missed.

All trials found during our search were first assessed by review of the abstract or, if no abstract is available or review of the abstract was insufficient, a decision was made after review of the full text of the article. All identified trials were reviewed in a non‐blinded fashion by two independent authors (BW and WS) to decide whether trials should have been included or excluded. If there was disagreement between authors, then the third author (SL) reviewed the trial and made the final decision as to inclusion or exclusion. If full articles were not available, abstracts were used if there was sufficient information. If there was inadequate information, then the primary author was contacted in an attempt to obtain necessary information. In cases of duplicate publications, all versions were reviewed.

Excluded trials were listed and reasons for exclusion were noted.

Data extraction 
 Data abstraction was recorded on the data abstraction form (see Additional Table 1) by two independent authors (BW) and (WS). If differences of opinion could not be resolved between the two authors, than the third author (SL) made the final decision.

Statistical assessment 
 The software package (RevMan Analyses) provided by The Cochrane Collaboration was used for all analyses (RevMan 2003).

Although the individual adverse events were analysed, as expected due to low adverse event rates and trials of small to moderate size, most attention was focused on analysis of the following five outcome variables: treatment failure, pancreatitis, total primary adverse events, and total adverse events.

The two treatment modalities were compared within each trial using the relative risk (RR) with 95% confidence intervals (CI). For continuous variables the weighted mean difference (WMD) between groups with 95% CI was used. Using each trial as a stratum, RRs were tested for homogeneity using a chi‐squared test. A P‐value of less than 0.10 was used as an indicator of significant heterogeneity; I² indices were reported to assist in evaluating the degree of heterogeneity. We analysed data by both a fixed‐effect and a random‐effects model analyses. If both fixed‐effect and random‐effects analyses were significant only one was reported. Random‐effects analysis was reported if both analyses demonstrated a significant difference as it gives wider confidence intervals and fixed‐effect analysis was reported if both analyses were nonsignificant as it gives tighter confidence intervals.

Regardless of heterogeneity, the following sub‐groups of study variables were examined:

(Note: Since individual patient data were not used for our analysis, means values were used for continuous variables. Also, in our attempt to dichotomize each trial for subgroup analysis majorities were used when appropriate to define each trial.)

• Trial quality

‐ Adequate generation of the allocation sequence versus unclear/no generation of the allocation sequence. 
 ‐ Adequate allocation concealment versus unclear/no allocation concealment. 
 ‐ Adequate blinding versus unclear/no blinding. 
 ‐ Adequate intention‐to‐treat analysis versus unclear/no intention‐to‐treat analysis.

• Size of biliary tract stones

‐ Smaller than 10 mm versus bigger than or equal to 10 mm.

• Number of biliary tract stones

‐ One stone or more than one stone.

• Stone removal characteristics

‐ Diameter of balloon dilation (less than or equal to 8 mm or larger than 8 mm). 
 ‐ Length of time of balloon dilation (less than 45 sec, more than or equal to 45 sec to less than 60 sec, or more than or equal to 60 sec).

• Use of somatostatin, octreotide, corticosteroids, gabexate, platelet activating agents, or other prokinase inhibiting agents for prevention of endoscopic retrograde cholangiopancreatography related pancreatitis versus no use.

• Pancreatic duct stenting prior to sphincteroplasty or sphincterotomy versus no use.

• Anatomy

‐ Surgical alteration: Billroth II, or Roux‐En‐Y, or hepaticojejunostomy, or normal anatomy.

• Pre‐existing coagulopathy versus normal coagulation.

• Pure versus blended cut currents during sphincterotomy.

• Study location (categorized by country/continent).

We had originally planned to examine each point of interest with scatterplots (with each trial as a data point) and to display the trial RR (y‐variable) in relation to variables, which might lead to heterogeneity. These variables would have included demographic variables, trial size, and trial quality. It was hypothesized that by dividing the trials into two or three sub‐groups, based on study variables, might produce reasonably other further homogeneous trial clusters which would then have been analysed in subgroups. However, these scatterplots were not carried out due to cost and time constraints.

A funnel plot was used on those trials included in the meta‐analysis to assess the potential for bias.

Our initial searches identified 50 potential publications. After reading the titles and abstracts, 33 were excluded because they were either duplicates, had no endoscopic sphincterotomy group, or were non‐clinical trials. One randomised trial was later excluded after contact with the primary author revealed that it was a quasi‐randomised study and another was composed of the same subset of patients from an earlier study. The reasons for exclusion are listed in the table 'Characteristics of excluded studies'.

The remaining 15 publications were randomised clinical trials that reported the random allocation of patients with common bile duct stones to endoscopic balloon dilation versus endoscopic sphincterotomy, thus fulfilling our inclusion criteria. These trials are listed in the table 'Characteristics of included studies'. Fourteen of these randomised trials were published in English and one was published in Korean (Cho 1998). Two trials were published only in abstract form (Chen 1998; Iwata 1998). Seven trials were from Japan, two from the Netherlands, one from China, one from Korea, one from the UK, one from Germany, one from the US, and one was from a US‐international collaboration.

We wrote to the primary authors of all included trials and received responses for only two authors. Both responses were from Dr. Jacques Bergman who clarified missing data for the two trials, which he had authored.

A total of 1768 patients were randomised with the smallest trial consisting of 34 participants and the largest consisting of 282. In total 878 were in the EBD group and 890 were in the ES group. The mean age of patients in the EBD groups ranged from 49 to 75 and in the ES groups from 47 to 71. The mean stone size extracted in the EBD groups ranged from 7 mm to 15.6 mm and in ES groups from 7.3 mm to 16.9 mm. The mean number of stones in the EBD groups ranged from 1.6 to 3.3 and in the ES groups from 1.0 to 3.5. The majority of patients in all the trials consisted of patients with normal anatomy except one trial (Bergman 2001a), which only assessed patients with a history of a Billroth II procedure. Eleven of the 15 trials used 8 mm diameter balloon dilators in the EBD group, while one used 6 mm to 10 mm balloons (Iwata 1998), one used 8 mm to 12 mm balloons (Lin 2004), one used 10 mm balloons (Vlavianos 2003), and one was unclear as to what size balloons were used (Chen 1998).

Thirteen trials examined treatment success and short‐term complications in their primary outcomes. One trial (Yasuda 2001) looked at long‐term manometric function and incidence of pneumobilia as its primary outcome, with treatment success and short‐term complications being secondary measures. Another trial (Iwata 1998) only published results regarding rates of mechanical lithotripsy and complications. Eight trials reported long‐term follow‐up (Bergman 1997a; Ochi 1999; Bergman 2001a; Yasuda 2001; Natsui 2002; Vlavianos 2003; Lin 2004; Tanaka 2004) with mean duration of follow‐up ranging from 6 months to 60 months. However, the long‐term results from the Yasuda 2001 trial were excluded because they also included a subset of retrospectively gathered patients and the randomised data could not be separated. Of these trials, one trial (Bergman 1997a) used 15 days as its time frame for short‐term complications while all other studies used the standard 30 days. Therefore, there is a chance that some of those long‐term complications may have by our definition actually been short‐term complications.

Six trials (Bergman 1997a; Bergman 2001a; Yasuda 2001; Fujita 2003; Vlavianos 2003; DiSario 2004) reported adequate generation of allocation sequence. Seven trials (Bergman 1997a; Bergman 2001a; Yasuda 2001; Natsui 2002; Fujita 2003; Vlavianos 2003; DiSario 2004) reported adequate allocation concealment. Two trials (Bergman 1997a; Bergman 2001a) provided adequate blinding by having a panel of blinded gastroenterologist who were unaware of the treatment allocations to classify and grade all complications. Five trials (Bergman 1997a; Bergman 2001a; Fujita 2003; Vlavianos 2003; DiSario 2004) reported the use of intention‐to‐treat analyses and their data appeared to have followed that principle.

Primary outcomes 
 Success 
 Seven trials detailed that EBD is less likely to extract the stone after the first attempt (73.5% versus 80.9%) (RR 0.90, 95% CI 0.84 to 0.97, random‐effects model). Only one trial (Bergman 1997a) included stone recurrence within the first six months with no significant results found when this was subtracted from the success of the individual procedure.

Subgroup analyses 
 The following subgroups were noted to yield a significant result demonstrating EBD is less likely to extract the stone after the first attempt: balloon size less than 8 cm, stone size less than 10 cm, age less than 60, age greater than 60, dilation time 45 to 60 seconds, and Asian trials.

Post hoc analysis 
 Thirteen trials reported rates of overall success showing that EBD is slightly less successful than ES for stone removal when repeated procedures of the same type are allowed (90.1% versus 95.3%) (RR 0.96, 95% CI 0.93 to 0.98, random‐effects model). It was also more likely that EBD would be switched to an alterative procedure, most commonly being ES (7.3% versus 0.3%) (RR 8.29, 95% CI 3.28 to 21.00, random‐effects).

Primary adverse event outcomes 
 Mortality 
 Seven trials reported mortality within the first 30 days of the procedure with no significant difference between the two groups (0.7% versus 0.3%) (RR 1.61, 95% CI 0.43 to 6.06, fixed‐effect). Rates of overall long‐term mortality were not available for analysis as they were not reported in any of the trials.

Subgroup analyses 
 None of the subgroup analyses yielded significant results as well.

Pancreatitis 
 Fourteen trials commented on the incidence of pancreatitis with a significant higher occurrence of total (overall) pancreatitis in patients treated with EBD than with ES (8.6% versus 4.3%) (RR 1.98, 95% CI 1.35 to 2.90, fixed‐effect). In total, mild pancreatitis comprised the majority of the cases when they were dichotomized to mild, moderate, and severe.

Subgroup analyses 
 The following subgroups yielded a significant result demonstrating a higher occurrence of total pancreatitis in patients treated with EBD than with ES: balloon size less than 8 cm, those using adequate allocation concealment, those using adequate allocation sequence, those using follow‐up (intention to treat), and age less than 60 years old. Also of note, Western trials demonstrated a significantly higher occurrence of pancreatitis in the EBD group (10.0% versus 3.8%) (RR 2.71, 95% CI 1.09 to 6.72, random‐effects).

Bleeding 
 Twelve trials commented on the occurrence of bleeding with a significantly lower occurrence of major bleeding in patients treated with EBD than with ES (0.1% versus 4.8%) (RR 0.15, 95% CI 0.06 to 0.39, random‐effects).

Subgroup analysis 
 All subgroups (except a dilation time less than 45 sec, anatomic variance) noted a significant result demonstrating a lower rate of major bleeding in patients with EBD than with ES.

Perforation 
 Nine trials commented on the incidence of perforation with no significant difference between the two groups (0.3% versus 0.5%) (RR 0.78, CI 95% 0.17 to 3.46, fixed‐effect).

Subgroup analyses 
 Subgroup analyses also did not yield any significant results.

Infection 
 Fourteen trials commented on the incidence of infection, demonstrating a significantly lower rate of short‐term total infection (cholangitis, non cholangitis, cholecystitis) in the EBD group compared with the ES group (2.5% versus 5.0%) (RR 0.55, 95% CI 0.31 to 0.96, random‐effects). Further post hoc subgrouping of this demonstrated that EBD carries a lower risk of subsequent short‐term cholecystitis if the gall bladder is left in situ as compared with ES (0.1% versus 0.5%) (RR 0.29, 95% CI 0.12 to 0.68, random‐effects). However, there was no significant difference in the occurrence of biliary or nonbiliary infections.

Subgroup analyses 
 The following subgroups yielded a significant result demonstrating a significantly lower rate of total infections: those using adequate allocation sequence, those using intention to treat, and age less than 60 years old.

Total combined primary adverse events 
 All fifteen trials were included with no statistically significant results for total primary adverse events (10.5% versus 9.9%) (RR 1.01, 95% CI 0.62 to 1.63, random‐effects model). There was significant heterogeneity by chi‐squared testing. Therefore only the random‐effects model is noted.

Subgroup analyses 
 Subgroup analyses also did not yield any significant results.

Secondary short‐term adverse events 
 When all fifteen trials were combined there was no statistically significant result for total short‐term complications (12.1% versus 12.7%) (RR 0.96, 95% CI 0.75 to 1.23, fixed‐effect model). With total short‐term complications there was significant heterogeneity by chi‐squared testing. Therefore, only the random‐effects model is noted. Only six trials commented on secondary adverse events with no significant difference noted (3.5% versus 3.0%) (RR 1.24 95% CI 0.61 to 2.50, fixed‐effect). There was inadequate data to analyse separately the various secondary adverse event outcomes, such as occurrence of pneumonia, adverse reactions to interventions, or others as defined by each trial as had been planned.

Subgroup analyses 
 Subgroup analyses also did not yield any significant results.

Other secondary outcomes 
 Long‐term complications 
 Seven trials assessed long‐term infections with follow‐up ranging from 6 to 60 months. Both total long‐term infections (2.4% versus 5.8%) (RR 0.44, 95% CI 0.21 to 0.91, fixed‐effect) (RR 0.43 (0.18 to 1.06), random‐effects) and total long‐term complications (9.7% versus 14.0%) (RR 0.69, 95% CI 0.48 to 0.98, fixed‐effect) (RR 0.72, 0.50 to 1.03, random‐effects) were found to be significantly reduced in the patients undergoing EBD only when a fixed‐effect model was applied. Using only the fixed‐effect model is acceptable given that no heterogeneity was detected by chi‐squared testing. When total infections were divided into cholangitis and acute cholecystitis, only acute cholecystitis demonstrated a significant result with a lower occurrence in the EBD group than in the ES group (1.3% versus 5.0%) (RR 0.29, 95% CI 0.10 to 0.81, random‐effects).

Subgroup analysis 
 The following subgroups yielded a significant result demonstrating lower occurrence of long‐term infections when EBD was used as compared with ES: dilation time 45 to 60 seconds, dilation time more than 60 seconds, and Asian trials.

Other long‐term complications 
 Stone recurrence was the only other long‐term complication with data to support an analysis with no significant difference between the EBD and ES groups (5.5% versus 5.7%) (RR 0.97, 95% CI 0.57 to 1.64, fixed‐effect model). Only one trial (Ochi 1999) commented on the occurrence of long‐term biliary stricture with no events occurring in either group. Otherwise, there were no trials that noted bile duct malignancy on follow‐up. Three trials (Minami 1995; Ochi 1999; Yasuda 2001) all found EBD more likely to preserve sphincter function. However, it was not within the scope of this study to examine these data.

Subgroup analyses 
 Subgroup analyses also did not yield any significant results.

Cost 
 No trials provided data regarding cost.

Post hoc analyses of mechanical lithotripsy 
 Mechanical lithotripsy 
 Thirteen trials examined the rates of mechanical lithotripsy demonstrating that EBD requires mechanical lithotripsy significantly more often than ES (20.0% versus 13.3%) (RR 1.34, 95% CI 1.08 to 1.66, random‐effects).

Funnel plots 
 Only funnel plots for total long‐term complications showed potential bias.

Our results yielded significant data on the benefits and potential risks of EBD versus ES for common bile duct stone removal. It was not surprising that EBD carries no risk of bleeding compared with an increased risk with ES. As EBD uses mechanical dilation of the sphincter of Oddi while ES involves a cut, bleeding is avoided in EBD. Therefore, EBD likely carries significant benefits over ES in patients with coagulopathy. 
 
 EBD also is noted to carry less risk for short‐term infections when a random‐effects model is applied and to carry less risk for long‐term infections, and total overall long‐term complications when a fixed‐effect model is applied. In this case it is reasonable to have confidence in our results using a fixed‐effect model as chi‐squared testing did not reveal any heterogeneity. For years proponents have argued that EBD preserves the biliary sphincter and therefore decreases the risk of bacterial contamination of the biliary tree, and these decreased risks of short‐ and long‐term infections likely corroborate the clinical significance of these claims. When examining our analysis of short‐ and long‐term infections the most significant impact EBD had in both groups was on lowering the risk of cholecystitis, and it appears likely that this variable significantly influenced the rates of overall infection. This is demonstrated by the fact that the RR for cholangitis and nonbiliary infection fell equally around 1.0, while the risk of cholecystitis heavily weighed the total (overall) rate of infection. This is an important concern in any patients with intact gallbladders, especially in those who will not undergo cholecystectomy. Also in regards to total long‐term complications, trials showed a tendency to decreased occurrence in the EBD group. It is this decreased risk of long‐term complications, which most proponents of EBD emphasize.

More importantly, the question remains regarding how these complications impact patient's quality of life and overall mortality. Unfortunately, none of these randomised trials addressed that issue, and it is unlikely that any similar trials in the future will do so. In addition, there were no recorded occurrences of biliary malignancy. As some theorize that rates of bile duct malignancy may be decreased with EBD and increased with ES, they occur infrequently and over long periods of time. Furthermore, the total number of patients studied is too small and the trials too short in duration to draw any meaningful conclusions.

Many endoscopists in US and various parts of the world have abandoned the use of EBD as a result of fears of increased risks of pancreatitis. Our analyses verified this fear. However, the more important question is whether this fear of pancreatitis ultimately translates into worse patient outcomes. It is still questionable from our analyses whether this increased risk of pancreatitis lends toward an increase in mortality. In fact, when our analysis examined overall mortality there was no statistically significant difference between EBD and ES. This evidence may negate the claims demonstrated in the DiSario 2004 trial. However, others may argue that although 1768 patients were included in our analyses this number may still have been too small to evaluate mortality, which carries a known low incidence with ERCP.

It is also interesting that pancreatitis carries more risks in the subgroup analysis for both Western trials and age of participants less than 60 years. When examined closely, these two groups compose roughly the same trials, indicating that Western trials enrolled younger participants. Conversely, Asian trials which comprised older participants (mean age greater than 60 years) carried no significantly increased risk of pancreatitis. It is unclear whether this association may be secondary strictly to age or other factors. It is also important to emphasize that this subgroup analysis using age was a post‐hoc decision and used an arbitrary age point. Therefore, the association from this analysis may very well be confounded.

Unfortunately, it was impossible to analyse whether length of time of balloon dilation and/or number of times of balloon dilation played significant roles in rates of pancreatitis as each trial used differing lengths of balloon dilation and numbers of balloon dilations. In addition, when all trials were subgrouped along the lines of trial quality yielding a mixture of high‐quality Western and Asian trials all but blinding (which only included the two Bergman trials) corroborated this increased risk of pancreatitis. Overall pancreatitis is a complication that typically would like to be avoided by most endoscopists, but to avoid using EBD altogether because of these fears may be unreasonable in certain populations.

Our analysis demonstrated the inferiority of EBD to ES regarding a number of other outcomes. EBD is slightly less successful overall in regards to stone removal (EBD 90.1% versus ES 95.3%). This 5.3% difference may seem trivial, however, this rate included the use of multiple repeat procedures. When ductal clearance was evaluated after first attempt, EBD was even less successful. Also as EBD is less successful, it not surprisingly requires a higher rate of an alternative procedure, which is most typically ES. It is well accepted that EBD creates a smaller passage for clearance of bile duct stones compared with ES and EBD may not destroy the biliary sphincter. Because of this, our analysis clearly finds that EBD consequently carries a higher rate of mechanical lithotripsy for stone clearance in conjunction with this need for repeated dilations.

Since the rates of perforation were so low no significant difference could be demonstrated between EBD and ES. Also, unfortunately no data were available on cost, quality scores, and length of hospital stay.

A meta‐analysis (Baron 2004) was published during the preparation of the present systematic review. Baron's et al study included only eight of our fifteen trials due to their language and publication type restrictions. Similarly to our study their outcomes included pancreatitis, bleeding, infection, perforation and death; however, they only examined these events within the first twenty‐four hours. Both meta‐analyses found a similar increased risk of pancreatitis and decreased risk of bleeding with EBD compared with ES. Also, both meta‐analyses found EBD to be significantly less successful overall for stone extraction; however, only our analysis found this to be statistically significant. Our analyses also go further by not only subdividing different outcomes into various subgroups (ie, mild, moderate, severe pancreatitis) but by also examining similar and other outcomes over the first 30 days and beyond.

Our meta‐analysis confirms that EBD is slightly less successful than ES in stone extraction. EBD is more likely to induce pancreatitis. However, in spite of the fear of death from pancreatitis caused by EBD, there is no convincing evidence that in regards to mortality EBD is more risky than ES. Furthermore, EBD appears to be superior to ES in patients who have prolonged bleeding times, who are at risk for infection, and possibly in those who are older. If the use of EBD is desired then the risks and benefits as compared with ES should be discussed with the patient.

Further trials are necessary to assess the risks and benefits of EBD compared with ES in selected populations (those prone to bleeding and those at risk for infection). Although roughly half of the previously conducted trials were designed with adequate randomisation, allocation concealment, and intention‐to‐treat methods, only two provided adequate blinding of outcome assessment. Therefore, future trials should not only focus on adequate generation of the allocation sequence, allocation concealment, and intention‐to‐treat methodologies, but also incorporate adequate blinding of those who follow‐up the patients after the intervention. Also, given the low incidence of many of these outcomes attempts at adequately powered trials are necessary to truly answer these questions. Future trials ought to be reported following the recommendations of the CONSORT Statement (www.consort‐statement.org).

Special thanks to Janice L. Contini, Head Reference Librarian at the UCLA, and Louise M. Darling Biomedical Library, who helped us develop our search strategy. Special thanks also to Janet D. Elashoff, Ph.D., Director of Biostatistics Core Research Institute at Cedars‐Sinai Medical Center, who helped us develop our statistical approaches for carrying out our analyses. Special thanks to Dr. Dong Ki Lee who provided a Korean to English translation for one of the articles. Great thanks to Dr. Ronald Koretz, Chief of Gastroenterology at UCLA ‐ Olive View Medical Center, who contributed significant mentoring to the development of the protocol and to the final systematic review.

Comparison 1 Primary outcomes (Technical success), Outcome 1 Stone removal on 1st attempt.

Comparison 1 Primary outcomes (Technical success), Outcome 2 Stone recurrence overall.

Comparison 2 Primary adverse event outcomes, Outcome 1 Mortality.

Comparison 2 Primary adverse event outcomes, Outcome 2 Total pancreatitis.

Comparison 2 Primary adverse event outcomes, Outcome 3 Bleeding.

Comparison 2 Primary adverse event outcomes, Outcome 4 Perforation.

Comparison 2 Primary adverse event outcomes, Outcome 5 Cholangitis.

Comparison 2 Primary adverse event outcomes, Outcome 6 Cholecystitis.

Comparison 2 Primary adverse event outcomes, Outcome 7 Nonbiliar infection.

Comparison 2 Primary adverse event outcomes, Outcome 8 Total Infections.

Comparison 2 Primary adverse event outcomes, Outcome 9 Total primary short‐term complications.

Comparison 3 Secondary adverse event outcomes, Outcome 2 Total secondary adverse events.

Comparison 3 Secondary adverse event outcomes, Outcome 3 Total overall short‐term complications.

Comparison 4 Other secondary outcomes, Outcome 1 Long‐term cholangitis.

Comparison 4 Other secondary outcomes, Outcome 2 Long‐term acute cholecystitis.

Comparison 4 Other secondary outcomes, Outcome 3 Total long‐term infections.

Comparison 4 Other secondary outcomes, Outcome 4 Total long‐term complications.

Comparison 5 Post hoc analysis, Outcome 1 Overall success rate (w/repeated procedure).

Comparison 5 Post hoc analysis, Outcome 2 Repeated same procedure.

Comparison 5 Post hoc analysis, Outcome 3 Switched to different procedure.

Comparison 5 Post hoc analysis, Outcome 4 Stone removal requiring mechanical lithotripsy.

Benjamin Weinberg: principle investigator/primary author. 
 Waleed Shindy: second author. 
 Simon Lo: advisor/third author.

• UCLA ‐ San Fernando Valley Program, USA.

• No sources of support supplied

None known.

Edited (no change to conclusions)

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