In Patients With Unexplained Abdominal Pain After Cholecystectomy, Sphincterotomy Does Not Reduce Disability Due to Pain

EBM Focus - Volume 9, Issue 25

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Reference: JAMA 2014 May 28;311(20):2101 (level 1 [likely reliable] evidence)

Gallbladder disease is estimated to result in more than 1 million hospitalizations and over 700,000 operations in the United States each year (J Gastrointest Surg 2012 Nov;16(11):2011). A pooled analysis of 2 randomized trials reported that over 25% of patients having cholecystectomy have persistent pain 5 years after surgery (J Gastrointest Surg 2005 Jul-Aug;9(6):826), often with no significant abnormalities on imaging or standard laboratory tests. Patients with persistent burdensome pain may have endoscopic retrograde cholangiopancreatography (ERCP) to identify another pathology or to assess potential sphincter of Oddi dysfunction, and some of these patients may also have subsequent sphincterotomy, though this procedure has not been shown to be beneficial in the absence of abnormal imaging or lab findings. A recent randomized trial compared sphincterotomy to sham surgery in 214 adults (92% women) with unexplained abdominal pain after cholecystectomy.

The trial included patients with unexplained abdominal pain for > 3 months after cholecystectomy and no prior sphincter intervention. All patients had ERCP prior to randomization. Patients were randomized to sphincterotomy (141 patients) vs. sham surgery (73 patients) and followed for 1 year. A total of 99 patients with elevated pancreatic sphincter pressure in sphincterotomy group were further randomized to biliary (single) sphincterotomy vs. biliary and pancreatic (dual) sphincterotomy. Treatment success was defined as < 6 days of disability due to pain without narcotic use or further sphincter intervention for 3 months.

The rate of treatment success at 1 year was 23% with sphincterotomy vs. 37% with sham (p = 0.01). There were no significant differences between sphincterotomy and sham groups in need for repeat ERCP intervention (37% vs. 25%) or rate of pancreatitis (11% vs.15%). In addition, there were no significant differences in treatment success comparing single vs. dual sphincterotomy in the subgroup of patients with elevated pancreatic sphincter pressure.

The management of unexplained postcholecystectomy pain can be frustrating for both the patient and their physicians, and data supporting current diagnostic options or treatment approaches are limited. The findings of this trial show that sphincterotomy does not reduce pain-related disability in patients with unexplained abdominal pain after cholecystectomy. About 12% of patients overall had pancreatitis following ERCP, consistent with previous data suggesting increased risk of both pancreatitis and perforation with this procedure (N Engl J Med 1996 Sep 26;335(13):909 full-text). Given the potential risks involved with sphincterotomy, its use in this patient population for the management of unexplained pain is not warranted.

For more information see the Cholecystectomy topic in DynaMed.