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Sphincterotomy vs sham does not reduce pain-related disability after cholecystectomy

A team of doctors examine the effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy, reports this weeks issue of the Journal of the American Medical Association.

News image

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.

Professor Peter Cotton and colleagues from South Carolina, USA determined whether endoscopic sphincterotomy reduces pain, and whether sphincter manometric pressure is predictive of pain relief.

The team performed a 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.

The patients were randomly assigned to undergo sphincterotomy or sham therapy at 7 referral medical centers, with a 1-year follow-up up to 2013.

After ERCP, patients were randomized to sphincterotomy or sham irrespective of manometry findings.
23% in the sphincterotomy group experienced successful treatment
Journal of the American Medical Association

Those randomized to sphincterotomy with elevated pancreatic sphincter pressures were randomized again to biliary or to both biliary and pancreatic sphincterotomies.

The team reported that 72 were entered into an observational study with conventional ERCP managemeny.

The researchers defined success of treatment 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.

The team found that 37% of patients in the sham treatment group vs 23% in the sphincterotomy group experienced successful treatment.

Of the patients with pancreatic sphincter hypertension, 30% who underwent dual sphincterotomy, and 20% who underwent biliary sphincterotomy alone experienced successful treatment.

The research team observed that 26% of patients treated, and 34% of patients in the sham group underwent repeat ERCP interventions.

Manometry results were not associated with the outcome.

The team noted that no clinical subgroups appeared to benefit from sphincterotomy more than others.

Pancreatitis occurred in 11% of patients after primary sphincterotomies, and in 15% in the sham group.

Of the nonrandomized patients in the observational study group, 24% who underwent biliary sphincterotomy, 31% who underwent dual sphincterotomy, and 17% who did not undergo sphincterotomy had successful treatment.

Professor Cotton's team concludes, "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."

JAMA 2014;311(20):2101-2109
29 May 2014

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