Effect of Endoscopic Sphincterotomy for Suspected Sphincter of Oddi Dysfunction on Pain-Related Disability Following Cholecystectomy

Abstract

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: 00688662

What Is New in Rome IV

“…67 However, a recent NIH study (EPISOD: evaluating predictors and interventions in sphincter of Oddi dysfunction) has shown that true sphincterotomy is no better than sham sphincterotomy in patients with post-cholecystectomy pain, so that the old concept of SOD Type III is now considered more like functional than biliary related, and endoscopic retrograde cholangiopancreatography approaches are no longer appropriate in that context. 68 Furthermore, most patients with SOD Type I have organic stenosis (eg, stones, stricture, pancreatitis, and pancreatic tumor) rather than motility disturbance of the sphincter, and biliary sphincterotomy is recommended; however not in this biliary classification. Therefore, Rome IV now recommends using the term suspected functional biliary sphincter of Oddi disorder for patients with prior SOD Type II only.…”

Sphincter of Oddi Manometry: Reproducibility of Measurements and Effect of Sphincterotomy in the EPISOD Study

“…7 The only study evaluating the value of both biliary and pancreatic manometry (in patients mostly classified as SOD type III) showed that neither were predictive of the outcome of sphincterotomies. 3 It would be helpful to have similarly stringent studies of dual manometry in patients with SOD type II. The putative gold standard loses even more credibility when we examine reproducibility.…”

“…3 They were aged 18 to 65 years, had burdensome pain more than 3 months after cholecystectomy, and fit the criteria of SOD type III. Patients underwent ERCP by experienced endoscopists, under conscious sedation, modified or full anesthesia, based on local practice.…”

Management of Sphincter of Oddi Dysfunction: Teaching an Old SOD New Tricks?

“…Neither biliary nor dual biliary and pancreatic sphincterotomy provided sustained pain relief compared to sham therapy. Furthermore, abnormal manometric findings failed to predict treatment success [8]. Post-ERCP pancreatitis occurred in 11 % of patients in the sphincterotomy group despite prophylactic pancreatic stenting [8].…”