Endoscopic sphincterotomy for adults with biliary sphincter of Oddi dysfunction.

BACKGROUND: The sphincter of Oddi comprises a muscular complex encircling the distal part of the common bile duct and the pancreatic duct regulating the outflow from these ducts. Sphincter of Oddi dysfunction refers to the abnormal opening and closing of the muscular valve, which impairs the circulation of bile and pancreatic juices. OBJECTIVES: To evaluate the benefits and harms of any type of endoscopic sphincterotomy compared with a placebo drug, sham operation, or any pharmaceutical treatment, administered orally or endoscopically, alone or in combination, or a different type of endoscopic sphincterotomy in adults with biliary sphincter of Oddi dysfunction. SEARCH METHODS: We used extensive Cochrane search methods. The latest search date was 16 May 2023. SELECTION CRITERIA: We included randomised clinical trials assessing any type of endoscopic sphincterotomy versus placebo drug, sham operation, or any pharmaceutical treatment, alone or in combination, or a different type of endoscopic sphincterotomy in adults diagnosed with sphincter of Oddi dysfunction, irrespective of year, language of publication, format, or outcomes reported. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods and Review Manager to prepare the review. Our primary outcomes were: proportion of participants without successful treatment; proportion of participants with one or more serious adverse events; and health-related quality of life. Our secondary outcomes were: all-cause mortality; proportion of participants with one or more non-serious adverse events; length of hospital stay; and proportion of participants without improvement in liver function tests. We used the outcome data at the longest follow-up and the random-effects model for our primary analyses. We assessed the risk of bias of the included trials using RoB 2 and the certainty of evidence using GRADE. We planned to present the results of time-to-event outcomes as hazard ratios (HR). We presented dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean difference (MD) with their 95% confidence intervals (CI). MAIN RESULTS: We included four randomised clinical trials, including 433 participants. Trials were published between 1989 and 2015. The trial participants had sphincter of Oddi dysfunction. Two trials were conducted in the USA, one in Australia, and one in Japan. One was a multicentre trial conducted in seven US centres, and the remaining three were single-centre trials. One trial used a two-stage randomisation, resulting in two comparisons. The number of participants in the four trials ranged from 47 to 214 (median 86), with a median age of 45 years, and the mean proportion of males was 49%. The follow-up duration ranged from one year to four years after the end of treatment. All trials assessed one or more outcomes of interest to our review. The trials provided data for the comparisons and outcomes below, in conformity with our review protocol. The certainty of evidence for all the outcomes was very low. Endoscopic sphincterotomy versus sham Endoscopic sphincterotomy versus sham may have little to no effect on treatment success (RR 1.05, 95% CI 0.66 to 1.66; 3 trials, 340 participants; follow-up range 1 to 4 years); serious adverse events (RR 0.71, 95% CI 0.34 to 1.46; 1 trial, 214 participants; follow-up 1 year), health-related quality of life (Physical scale) (MD -1.00, 95% CI -3.84 to 1.84; 1 trial, 214 participants; follow-up 1 year), health-related quality of life (Mental scale) (MD -1.00, 95% CI -4.16 to 2.16; 1 trial, 214 participants; follow-up 1 year), and no improvement in liver function test (RR 0.89, 95% CI 0.35 to 2.26; 1 trial, 47 participants; follow-up 1 year), but the evidence is very uncertain. Endoscopic sphincterotomy versus endoscopic papillary balloon dilation Endoscopic sphincterotomy versus endoscopic papillary balloon dilationmay have little to no effect on serious adverse events (RR 0.34, 95% CI 0.04 to 3.15; 1 trial, 91 participants; follow-up 1 year), but the evidence is very uncertain. Endoscopic sphincterotomy versus dual endoscopic sphincterotomy Endoscopic sphincterotomy versus dual endoscopic sphincterotomy may have little to no effect on treatment success (RR 0.65, 95% CI 0.32 to 1.31; 1 trial, 99 participants; follow-up 1 year), but the evidence is very uncertain. Funding One trial did not provide any information on sponsorship; one trial was funded by a foundation (the National Institutes of Diabetes and Digestive and Kidney Diseases, NIDDK), and two trials seemed to be funded by the local health institutes or universities where the investigators worked. We did not identify any ongoing randomised clinical trials. AUTHORS' CONCLUSIONS: Based on very low-certainty evidence from the trials included in this review, we do not know if endoscopic sphincterotomy versus sham or versus dual endoscopic sphincterotomy increases, reduces, or makes no difference to the number of people with treatment success; if endoscopic sphincterotomy versus sham or versus endoscopic papillary balloon dilation increases, reduces, or makes no difference to serious adverse events; or if endoscopic sphincterotomy versus sham improves, worsens, or makes no difference to health-related quality of life and liver function tests in adults with biliary sphincter of Oddi dysfunction. Evidence on the effect of endoscopic sphincterotomy compared with sham, endoscopic papillary balloon dilation,or dual endoscopic sphincterotomyon all-cause mortality, non-serious adverse events, and length of hospital stay is lacking. We found no trials comparing endoscopic sphincterotomy versus a placebo drug or versus any other pharmaceutical treatment, alone or in combination. All four trials were underpowered and lacked trial data on clinically important outcomes. We lack randomised clinical trials assessing clinically and patient-relevant outcomes to demonstrate the effects of endoscopic sphincterotomy in adults with biliary sphincter of Oddi dysfunction.

The efficacy and safety of endoscopic sphincterotomy in patients with Sphincter of Oddi dysfunction: a systematic review and meta-analysis.

OBJECTIVE: Sphincter of Oddi dysfunction (SOD) has been used to describe patients with RUQ abdominal pain without an etiology. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of ES (endoscopic sphincterotomy) for SOD. METHODS: The study methodology follows the PRISMA guidelines. A comprehensive search was conducted using MEDLINE and EMBASE databases for RCTs with ES in patients with SOD. The primary outcome assessed was the improvement of abdominal pain after ES/sham. A random effects model was used to calculate pooled estimates for each outcome of interest. RESULTS: Of the initial 55 studies, 23 were screened and thoroughly reviewed. The final analysis included 3 studies. 340 patients (89.7% women) with SOD were included. All patients had a cholecystectomy. Most included patients had SOD type II and III. The pooled rate of technical success of ERCP was 100%. The average clinical success rate was 50%. The pooled cumulative rate of overall AEs related to all ERCP procedures was 14.6%. In the sensitivity analysis, only one study significantly affected the outcome or the heterogeneity. CONCLUSION: ES appears no better than placebo in patients with SOD type III. Sphincterotomy could be considered in patients with SOD type II and elevated SO basal pressure.

The Next EPISOD: Trends in Utilization of Endoscopic Sphincterotomy for Sphincter of Oddi Dysfunction from 2010-2019.

BACKGROUND & AIMS: For years, the endoscopic management of the disorder formerly known as Type III Sphincter of Oddi Dysfunction (SOD) had been controversial. In 2013, the results of the Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD) trial demonstrated that there was no benefit associated with endoscopic sphincterotomy for patients with Type III SOD. We aimed to assess the utilization of endoscopic sphincterotomy for patients with SOD in a large population database from 2010-2019. METHODS: We searched a large electronic health record (EHR)-based dataset incorporating over 300 individual hospitals in the United States (Explorys, IBM Watson health, Armonk, NY). Using Systematized Nomenclature of Medicine Clinical Terms (SNOMED-CT) we identified patients with a first-ever diagnosis of "disorder of Sphincter of Oddi" annually from 2010-2019. Subclassification of SOD types was not feasible using SNOMED-CT codes. Stratified by year, we identified the proportion of patients with newly-diagnosed SOD undergoing endoscopic sphincterotomy and those receiving newly-prescribed medical therapy. RESULTS: A total of 39,950,800 individual patients were active in the database with 7,750 index diagnoses of SOD during the study period. The incidence rates of SOD increased from 2.4 to 12.8 per 100,000 persons from 2010-2019 (P < .001). In parallel, there were reductions in the rates of biliary (34.3% to 24.5%) and pancreatic sphincterotomy (25% to 16.4%), respectively (P < .001). Sphincter of Oddi manometry (SOM) was infrequently utilized, <20 times in any given year, throughout the study duration. There were no significant increases in new prescriptions for TCAs, nifedipine, or vasodilatory nitrates. CONCLUSIONS: Among a wide range of practice settings which do not utilize routine SOM, a sudden and sustained decrease in rates of endoscopic sphincterotomy for newly-diagnosed SOD was observed beginning in 2013. These findings highlight the critical importance of high-quality, multi-center, randomized controlled trials in endoscopy to drive evidence-based changes in real-world clinical practice.

The EPISOD study: long-term outcomes.

BACKGROUND AND AIMS: The EPISOD (Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction) study randomized patients with post-cholecystectomy pain, and little or no objective evidence for biliary obstruction, to sphincterotomy or sham intervention. Results at 1 year showed no benefit for the active treatment. We now report the outcomes at up to 5 years. METHODS: One hundred three patients completing 1 year, and still blinded to treatment allocation, were enrolled and followed by phone every 6 months for a median of 58 months (range, 17-71 months). Their success was assessed at the final visit by 2 criteria: (1) a low pain score (Recurrent Abdominal Pain and Disability instrument [RAPID] <6) and (2) much or very much improved on the Patients' Global Impression of Change (PGIC) questionnaire (both with no repeat intervention and not taking narcotics). RESULTS: By the RAPID criteria, success rates for the patients in the sphincterotomy and sham arms were similar: 26/65 (40%) versus 16/38 (42%), respectively. However, by the PGIC criteria, actively treated patients fared worse: 16/43 (37%) versus 16/22 (73%). A total of 75 patients underwent active treatment during the entire study. Their success rate by the RAPID criteria was 31 (41%) compared with 16 (62%) who had no active treatment at any time. CONCLUSIONS: These data confirm our initial report that endoscopic sphincterotomy is no better than sham intervention in these patients (and, by some criteria, worse), and that ERCP can no longer be recommended. The patients have genuine and often severe symptoms, and further research is needed to establish effective management. (Clinical trial registration number: 00688662 05/3/2008.).

Spiral enteroscopy-assisted ERCP in bariatric-length Roux-en-Y anatomy: a large single-center series and review of the literature (with video).

BACKGROUND: Deep enteroscopy-assisted ERCP (DEA-ERCP) in post-bariatric Roux-en-Y (RY) anatomy is challenging. Laparoscopy-assisted ERCP (LA-ERCP) and EUS-directed transgastric ERCP (EDGE) are technically easier and faster but are more invasive and morbid procedures. Therefore, we have used DEA-ERCP as our first-line approach, reserving EDGE and LA-ERCP for cases in which adjunctive techniques that cannot be performed through an enteroscope are required (eg, EUS-FNA, sleeve sphincter of Oddi manometry), or DEA-ERCP failures. The 2 main methods for DEA-ERCP are balloon- and spirus-assisted. Current literature on spiral enteroscopy ERCP (SE-ERCP) in bariatric RY anatomy is scant with low success rates reported. Our center has nearly exclusively used SE-ERCP for bariatric patients. Here, we report one of the largest such series to date. METHODS: This is a retrospective cohort study of consecutive patients with bariatric-length RY anatomy who had SE-ERCP from December 2009 to October 2016 at a tertiary care center, by one operator (S.N.S.). Primary outcomes included success at reaching the papilla, cannulation success, success of desired therapeutic intervention, and overall SE-ERCP success. RESULTS: Thirty-five SE-ERCPs were performed (28 in bariatric RY gastric bypass and 7 other long-limb RY surgical reconstructions). The papilla was reached in 86% (30/35) of cases. Cannulation success in patients in whom deep cannulation was indicated (28/30) was 100% (28/28 cases, including the 24 cases with native papilla). Therapeutic ERCP success was 100% (28/28). Overall SE-ERCP success was 86% (30/35). Median length of stay was 3 days. Median procedure time was 189 minutes. Reasons for SE-ERCP failures included RY anastomosis stricture, adhesions (2), long Roux limb, and redundant small bowel. Two of these patients underwent interventional radiology-guided percutaneous biliary drainage, 2 patients had laparoscopy-assisted ERCP, and 1 patient had EUS-guided antegrade cholangioscopy with sphincteroplasty and stone clearance. There were no adverse events. CONCLUSION: With sufficient allotted time (median procedure time ∼3 hours) and high operator experience (a single-operator volume that exceeds that of other published series), SE-ERCP is safe and effective in bariatric, long-limb RY patients with an overall success rate of 86%, which is higher than previously reported.

Early precut is as efficient as pancreatic stent in preventing post-ERCP pancreatitis in high-risk subjects - A randomized study.

BACKGROUND: The most common adverse event of endoscopic retrograde cholangiopancreatography is pancreatitis. Precut sphincterotomy has been regarded as a risk factor. Some authors have stated that early precut may actually reduce post-ERCP pancreatitis risk. However, early precut as a preventive measure has not been compared to other preventive measures, such as pancreatic duct stent placement. AIM: To compare the efficacy of early precut sphincterotomy versus pancreatic duct stent placement in high-risk subjects undergoing endoscopic retrograde cholangiopancreatography for the prevention of post-endoscopic cholangiopancreatography. MATERIALS AND METHODS: This was a single-blinded, randomized trial that took place in two tertiary referral centers in Buenos Aires, from November 2011 to December 2013. ERCP subjects presented at least one of the following risk factors: female sex, age less than 40 years, clinical suspicion of sphincter of Oddi dysfunction, previous pancreatitis, and/or common bile duct diameter of less than 8 mm. Only those who presented a difficult biliary cannulation were randomized into two groups: those who received early precut sphincterotomy and those in whom persistency of biliary cannulation was intended, with subsequent pancreatic duct stent placement after cholangiography was achieved. The incidence of post-ERCP pancreatitis, as well as other adverse events incidence, was compared. RESULTS: Overall, 101 patients were enrolled, 51 in the pancreatic duct stent group and 50 in the early precut group. Pancreatitis rate was similar in both groups (3.92% vs 4%, p NS). In all cases, pancreatitis was classified as mild. There were no deaths registered. CONCLUSION: Early precut was associated with an incidence of adverse events similar to pancreatic duct stent placement.

Incidence and predictors of post-ERCP pancreatitis in patients with suspected sphincter of Oddi dysfunction undergoing biliary or dual sphincterotomy: results from the EPISOD prospective multicenter randomized sham-controlled study.

BACKGROUND AND STUDY AIM: Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a significant and potentially life-threatening adverse event and is common in patients with suspected sphincter of Oddi dysfunction (SOD). Here we aimed to identify predictors of the risk in this population. PATIENTS AND METHODS: The Evaluating Predictors and Interventions in SOD (EPISOD) study prospectively enrolled 214 post-cholecystectomy patients with SOD type III in seven US centers. Patients were randomized, using a 2:1 allocation, to sphincterotomy or sham procedure, irrespective of the results of sphincter of Oddi manometry. Patients in the sphincterotomy arm who had elevated pancreatic sphincter pressure were randomized to biliary only or to dual (biliary and pancreatic) sphincterotomy. All but one patient received prophylactic pancreatic stents, but none received pharmacological prophylaxis. Post ERCP pancreatitis (PEP) was defined as acute pancreatitis within the subsequent 7 days. Blinded research coordinators at each site called patients at 1 week post-procedure. RESULTS: PEP occurred in 26 patients, in 10.6 % (15/141) in the sphincterotomy arm and 15.1 % (11/73) in the sham arm; unadjusted relative risk 0.71 (95 % confidence interval [95 %CI] 0.34 - 1.46). PEP rate was not significantly different in patients who received sphincterotomy compared with those undergoing sham treatment. In addition, the proportion was not statistically different in those who received biliary sphincterotomy alone (12/94; 12.8 % [95 %CI 6.0 % - 19.5 %]) compared with dual sphincterotomy (3/47; 6.4 % [95 %CI 0.0 % - 13.4 %]). Multivariate analysis identified an interaction between duration of ERCP and sedation type (P < 0.02). CONCLUSION: The performance of biliary or dual sphincterotomy does not increase the risk of PEP in patients suspected of SOD. However, the high rate of PEP in patients with suspected SOD, despite pancreatic stenting in expert centers, is confirmed in this prospective study. The combined effect of duration of ERCP and sedation type on the development of PEP should be further explored.Clinicaltrials.gov registration: NCT00688662.

Psychosocial characteristics and pain burden of patients with suspected sphincter of Oddi dysfunction in the EPISOD multicenter trial.

OBJECTIVES: Patients with several painful functional gastrointestinal disorders (FGIDs) are reported to have a high prevalence of psychosocial disturbance. These aspects have not been studied extensively in patients with suspected Sphincter of Oddi dysfunction (SOD). METHODS: A total of 214 patients with post-cholecystectomy pain and suspected SOD were enrolled in seven US centers in a multicenter-randomized trial (Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction). Baseline assessments included pain descriptors and burden, structured psychosocial assessments of anxiety/depression, coping, trauma, and health-related quality of life. Patients with high levels of depression, suicidal ideation, or psychosis were excluded. RESULTS: The study population (92% female, mean age 38) reported anxiety (9%), depression (8%), past sexual trauma (18%), and physical abuse (10%). Of the total screened population (n=1460), 3.9% of the patients were excluded because of the presence of defined severe psychological problems. The mean medical outcomes study short-form-36 (SF-36) physical and mental composite scores were 38.70 (s.d.=7.89) and 48.74 (s.d.=9.60), respectively. Most subjects reported symptoms of other FGIDs. There were no correlations between the extent of the pain burden in the 3 months before enrollment and the baseline anxiety scores or victimization history. However, those with greater pain burden were significantly more depressed. There were no meaningful differences in the psychosocial parameters in subjects with or without irritable bowel, and those who had cholecystectomy for stones or functional gallbladder disease. Those declining randomization were comparable to those randomized. CONCLUSIONS: Psychosocial comorbidity in SOD is high. However, it does not appear to differ significantly from that reported in surveys of age- and gender-matched general populations, and may be lower than reported with other FGIDs.

Impact of pancreatic stent caliber on post-endoscopic retrograde cholangiopancreatogram pancreatitis rates in patients with confirmed sphincter of Oddi dysfunction.

BACKGROUND: Despite proven clinical benefit, there are no studies that have examined the relationship between pancreatic stent caliber and its impact on PEP [post-endoscopic retrograde cholangiopancreatogram (ERCP) pancreatitis] in high-risk patients. AIM: To study the relationship between stent caliber and PEP rates in patients with confirmed sphincter of Oddi dysfunction (SOD). METHODS: A retrospective review was conducted of ERCP's in patients with SOD from 2002 to 2012 from a prospectively maintained, Institutional Review Board approved database. RESULTS: A total of 243/7659 (3.2%) patients underwent 3Fr or 5Fr pancreatic stent placement following sphincterotomy for manometry-proven SOD. Of these, 133 (54.7%) underwent 3Fr stent placement, while 110 (45.3%) underwent 5Fr stent placement. There was no significant difference between the two groups in terms of baseline characteristics, demographics, and previous cholecystectomy. Cannulation and stent placement success rates were 100% in both groups. There was no significant difference in rates of PEP and overall complications, 12% versus 12.7%; P = 0.89 and 13.5% versus 15.5%; P = 0.54, between the 3Fr and 5Fr cohorts, respectively. There were more mild PEP rates recorded in 5Fr group (93% vs 56% P = 0.0549) that was not statistically significant. CONCLUSIONS: There appears to be no relationship between stent characteristics and the risk or severity of PEP in patients with manometrically proven SOD.

Gallbladder dysfunction: how much longer will it be controversial?

BACKGROUND: Motility disorders of the biliary tree [biliary dyskinesia, including both gallbladder dysfunction (GBD), and sphincter of Oddi dysfunction] are difficult to diagnose and to treat. SUMMARY: There is controversy in the literature in particular regarding the criteria that should be used to select patients for cholecystectomy (CCY) in cases of suspected GBD. The current review covers the history, diagnosis, and treatment of GBD. Key Messages: Only >85% of patients with suspected GBD have relief following CCY, a much lower rate than the nearly 100% success rate following CCY for gallstone disease. Unfortunately, the literature is lacking, and there are no universally agreed-upon criteria for selecting which patients to refer for operation, although cholecystokinin (CCK)-enhanced hepatobiliary iminodiacetic acid scan is often used, with emphasis on an abnormally low gallbladder ejection fraction or pain reproduction at CCK administration. There is a clear need for large, well-designed, more definitive, prospective studies to better identify the indications for and efficacy of CCY in cases of GBD.

Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial.

IMPORTANCE: Abdominal pain after cholecystectomy is common and may be attributed to sphincter of Oddi dysfunction. Management often involves endoscopic retrograde cholangiopancreatography (ERCP) with manometry and sphincterotomy. OBJECTIVE: To determine whether endoscopic sphincterotomy reduces pain and whether sphincter manometric pressure is predictive of pain relief. DESIGN, SETTING, AND PATIENTS: Multicenter, sham-controlled, randomized trial involving 214 patients with pain after cholecystectomy without significant abnormalities on imaging or laboratory studies, and no prior sphincter treatment or pancreatitis randomly assigned (August 6, 2008-March 23, 2012) to undergo sphincterotomy or sham therapy at 7 referral medical centers. One-year follow-up was blinded. The final follow-up visit was March 21, 2013. INTERVENTIONS: After ERCP, patients were randomized 2:1 to sphincterotomy (n = 141) or sham (n = 73) irrespective of manometry findings. Those randomized to sphincterotomy with elevated pancreatic sphincter pressures were randomized again (1:1) to biliary or to both biliary and pancreatic sphincterotomies. Seventy-two were entered into an observational study with conventional ERCP managemeny. MAIN OUTCOMES AND MEASURES: Success of treatment was defined as less than 6 days of disability due to pain in the prior 90 days both at months 9 and 12 after randomization, with no narcotic use and no further sphincter intervention. RESULTS: Twenty-seven patients (37%; 95% CI, 25.9%-48.1%) in the sham treatment group vs 32 (23%; 95% CI, 15.8%-29.6%) in the sphincterotomy group experienced successful treatment (adjusted risk difference, -15.6%; 95% CI, -28.0% to -3.3%; P = .01). Of the patients with pancreatic sphincter hypertension, 14 (30%; 95% CI, 16.7%-42.9%) who underwent dual sphincterotomy and 10 (20%; 95% CI, 8.7%-30.5%) who underwent biliary sphincterotomy alone experienced successful treatment. Thirty-seven treated patients (26%; 95% CI,19%-34%) and 25 patients (34%; 95% CI, 23%-45%) in the sham group underwent repeat ERCP interventions (P = .22). Manometry results were not associated with the outcome. No clinical subgroups appeared to benefit from sphincterotomy more than others. Pancreatitis occurred in 15 patients (11%) after primary sphincterotomies and in 11 patients (15%) in the sham group. Of the nonrandomized patients in the observational study group, 5 (24%; 95% CI, 6%-42%) who underwent biliary sphincterotomy, 12 (31%; 95% CI, 16%-45%) who underwent dual sphincterotomy, and 2 (17%; 95% CI, 0%-38%) who did not undergo sphincterotomy had successful treatment. CONCLUSIONS AND RELEVANCE: In patients with abdominal pain after cholecystectomy undergoing ERCP with manometry, sphincterotomy vs sham did not reduce disability due to pain. These findings do not support ERCP and sphincterotomy for these patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00688662.

[Stenosing papillitis--a problem of miniinvasive surgery].

The results of conduction of endoscopic transpapillary interventions in 976 patients, suffering stenosing papillitis in 2000 - 2014 yrs, were summarized. In 48 (4.9%) patients complications have had occurr, all the patients are alive.

Similar efficacies of biliary, with or without pancreatic, sphincterotomy in treatment of idiopathic recurrent acute pancreatitis.

BACKGROUND & AIMS: The role of sphincter of Oddi manometry (SOM) in the management of patients with idiopathic recurrent acute pancreatitis requires clarification. We evaluated the therapeutic effects of endoscopic sphincterotomy in patients with recurrent acute pancreatitis and the prognostic significance of pancreatic sphincter dysfunction (SOD). METHODS: We performed a randomized trial of endoscopic retrograde cholangiopancreatography with SOM for patients with idiopathic recurrent acute pancreatitis. Patients with pancreatic SOD (n = 69) were assigned randomly to groups that received only biliary sphincterotomy (BES) or a combination of biliary and pancreatic sphincterotomy (DES); patients who underwent normal SOM (n = 20) were assigned randomly to groups that received BES or a sham surgery. The primary outcome was incidence of recurrent acute pancreatitis during the follow-up period (minimum, 1 year; maximum, 10 years). We also determined the incidence of chronic pancreatitis and analyzed factors associated with recurrence of acute pancreatitis. RESULTS: Among the 69 patients with SOD, 48.5% who received BES and 47.2% who received DES had recurrent acute pancreatitis (95% confidence interval, -22.3 to 24.9; P = 1.0). In patients with normal SOM (n = 20), 27.3% of those who received BES and 11.1% of those who received the sham surgery had recurrent acute pancreatitis (95% confidence interval, -49.5 to 17.2; P = .59). Overall, 16.9% of subjects developed chronic pancreatitis during a median follow-up period of 78 months (interquartile range, 35-108 mo). The odds of recurrent acute pancreatitis during follow-up evaluation were significantly greater among patients with SOD than those with normal SOM (unadjusted hazard ratio, 3.5; 95% confidence interval, 1.07-11.4; P < .04), and remained so after adjusting for potential confounders (hazard ratio, 4.3; 95% confidence interval, 1.3-14.5; P < .02). CONCLUSIONS: Among patients with pancreatic SOD, DES and BES have similar effects in preventing recurrence of acute pancreatitis. Pancreatic SOD is an independent prognostic factor, identifying patients at higher risk for recurrent acute pancreatitis. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov (NCT01583517).

Single-session ERCP in patients with previous Roux-en-Y gastric bypass using percutaneous-assisted transprosthetic endoscopic therapy: a case series.

Endoscopic retrograde cholangiopancreatography (ERCP) remains technically challenging following Roux-en-Y gastric bypass (RYGB). Various techniques have been described to access the excluded stomach. We describe our experience using percutaneous-assisted transprosthetic endoscopic therapy (PATENT) to perform antegrade ERCP. Balloon enteroscopy was used to access the excluded stomach. Direct retrograde percutaneous endoscopic gastrostomy (RPEG) was performed and an esophageal self-expandable metal stent (SEMS) was deployed within the gastrostomy tract. A duodenoscope was advanced through the SEMS and antegrade ERCP was performed. Following ERCP, a gastrostomy tube was placed through the SEMS to maintain patency. Five patients underwent successful antegrade ERCP using PATENT. All patients had a diagnosis of sphincter of Oddi dysfunction. Biliary sphincterotomy was performed in all patients and liver enzymes normalized in four patients with preprocedural elevations. In conclusion, antegrade ERCP employing PATENT is feasible and can be performed during a single endoscopic session in patients with previous RYGB.

Contemporary Outcomes of Transduodenal Sphincteroplasty: the Importance of Surgical Quality.

BACKGROUND: Sphincter of Oddi dysfunction (SOD) is managed primarily by endoscopic sphincterotomy (ES); however, surgical transduodenal sphincteroplasty (TDS) is a treatment option for select patients. In our high-volume pancreatico-biliary practice, we have observed variable outcomes among TDS patients; therefore, we sought to determine preoperative predictors of durable improvement in quality of life. METHODS: SOD patients treated by TDS between January 2006 and December 2015 were studied. The primary outcome measure was long-term changes in quality of life after sphincteroplasty. The secondary outcome measure examined postoperative outcomes, including postoperative complications, need for repeat procedures, and readmission rates. Perioperative data were abstracted, and the SF-36 quality-of-life (QoL) survey was administered. Standard statistical analysis included non-parametric methods to examine bivariate associations. RESULTS: Eighty-eight patients had an average follow-up duration of 6.7 (± 2.9) years. Thirty (34%) patients were naïve to endoscopic therapy. Patients with prior endoscopy averaged 2.1 procedures (range 1 to 13) prior to surgery. Perioperative morbidity was 27%; one postoperative death was caused by severe acute pancreatitis. Twenty-nine (33%) patients required subsequent biliary-pancreatic procedures. QoL analysis from available patients showed that 66% were improved or much improved. With multivariable analysis including SOD type and prior endoscopic instrumentation, freedom from surgical complication was the only variable that correlated significantly with a good outcome (p < 0.02). CONCLUSION: Surgical transduodenal sphincteroplasty provides durable symptom management for select patients with sphincter of Oddi dysfunction. Minimizing surgical complications optimizes long-term outcomes.

Transduodenal Sphincteroplasty: A Visual Case Study.

BACKGROUND: Sphincter of Oddi dysfunction is a challenging and rare clinical entity resulting in pancreatobiliary pain and stasis of bile and pancreatic juice. This problem was classically treated with surgical therapy, but as classification of the disease has changed and newer methods of endoscopic evaluation and therapy have evolved, operative transduodenal sphincteroplasty is now generally reserved as a final therapeutic option for these patients. In this video and manuscript, we describe our approach to operative transduodenal sphincteroplasty in a patient with type I Sphincter of Oddi dysfunction. METHODS: A 50-year-old female with history of Roux-en-Y gastric bypass presented with episodic right-upper-quadrant and epigastric abdominal pain with associated documented elevations in liver chemistries. Preoperative cross-sectional imaging demonstrated dilation of her common bile duct. After multidisciplinary discussion, the decision was made to pursue operative transduodenal sphincteroplasty. RESULTS: All key operative steps of the transduodenal sphincteroplasty are demonstrated in the embedded video. Key operative steps include laparotomy, generous Kocher maneuver, and duodenotomy over the ampulla, allowing access for sequential biliary and pancreatic sphincterotomies and sphincteroplasties with absorbable suture. The duodenotomy and abdominal fascia are then closed. Our patient underwent sequential diet advancement and was discharged to home on postoperative day five. At clinic follow-up, pancreatobiliary-type pain had resolved. CONCLUSION: The embedded video demonstrates a case of operative transduodenal sphincteroplasty, which can provide durable results in appropriate patient populations.

The diagnosis and management of Sphincter of Oddi dysfunction: a systematic review.

OBJECTIVES: Sphincter of Oddi dysfunction (SOD) is a benign pathological syndrome. The clinical manifestations may be a consequence of an anatomical stenosis or sphincter dysmotility. Manometry is invasive and has an associated morbidity. Non-invasive investigations have been evaluated to ameliorate risk but have unknown efficacy. The review aims to critically appraise current evidence for the diagnosis and management of SOD. METHODS: A systematic review of articles containing relevant search terms was performed. RESULTS: Manometry is the current gold standard in selecting which patients are likely to benefit from endoscopic sphincterotomy (ES). It can, however, be misleading. Several non-invasive investigations were identified. These have poor sensitivities and specificities compared to manometry. There is a paucity of data examining the investigation's specific ability to select patients for ES. Outcomes of ES for Type I SOD are favourable irrespective of manometry. Types II and III SOD may respond to an initial trial of medical therapy. Manometry may predict response to ES in Type II SOD, but not in Type III. CONCLUSIONS: Non-invasive investigations currently lack sufficient sensitivities and specificities for routine use in diagnosing SOD. Type I SOD should be treated with ES without manometry. Manometry may be useful for Type II SOD. However, whilst data is lacking a therapeutic trial of Botox(TM) or trial stenting may bean alternative. Careful and thorough patient counselling is essential. Type III SOD is associated with high complications from manometry and poor outcomes from ES. Alternative diagnoses should be thoroughly sought and its management should be medical.

Laparoscopic distal pancreatectomy for retrieval of a proximally migrated pancreatic stent.

BACKGROUND AND OBJECTIVES: Pancreatic stents placed by ERCP are common in the treatment of benign and malignant pancreatic and biliary disease. Proximal migration of the stent into the duct occurs in 2% to 5% of cases, often resulting in pancreatitis. Although technically challenging, proximally migrated pancreatic stents can usually be removed endoscopically. Little has been written about surgical management of irretrievable stents, and no reports of laparoscopic approaches were found. METHODS: We report on a case of unsuccessful ERCP retrieval of a proximally migrated pancreatic stent. RESULTS: Using laparoscopy, we exposed the pancreas and used ultrasound to locate the distal end of the stent. We incised the pancreas at that point, removed the stent, and completed the distal pancreatectomy with splenectomy. DISCUSSION: Several case series on retrieval of migrated pancreatic stents are reviewed. CONCLUSION: Although ERCP is often successful and sometimes requires several attempts, we recommend surgical consultation after the first or second failed ERCP.