1. Endoscopic sphincterotomy did not relieve unexplained post-cholecystectomy abdominal pain due to suspected biliary Sphincter of Oddi (SOD) dysfunction.
2. Manometry readings of biliary and pancreatic sphincter pressures was not useful in predicting the success of sphincterotomy.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Abdominal pain of unexplained etiology is a frequent complaint after cholecystectomy. Sphincter of Oddi dysfunction (SOD) dysfunction is suspected in these cases and treated through endoscopic biliary sphincterotomy with or without pancreatic sphincterotomy. The decision to perform sphincterotomies is often based upon the detection of sphincter hypertension by endoscopic manometry. This study is the first randomized sham-controlled trial to determine the effect of sphincterotomy on pain relief and whether manometry readings are indicators for the potential success of sphincterotomy. The study found that endoscopic sphincterotomy is not effective for pain relief and manometry cannot identify which patients will benefit from sphincterotomy.
By demonstrating that endoscopic sphincterotomy does not adequately treat the abdominal pain, this study provides evidence against the use of this potentially harmful procedure in the above context. Endoscopic manometry could also be eliminated from the decision-making process. However, this study has some limitations. While patients in the sham group did not undergo sphincterotomy, all patients underwent endoscopic retrograde cholangiopancreatography (ERCP) with manometry and temporary pancreatic stenting, which could possibly influence the positive outcomes in the sham group.
In-Depth [randomized controlled trial]: This study enrolled 214 adults with post-cholecystectomy pain. All patients underwent initial ERCP with manometry and were randomized 2:1 to sphincterotomy or a sham procedure. In the sphincterotomy group, patients with pancreatic hypertension were randomized 1:1 to biliary or dual biliary and pancreatic sphincterotomy while those without pancreatic hypertension underwent only biliary sphincterotomy. Successful pain reduction was defined days of lost productivity, need for another intervention and narcotic use. At 12 months, 37% of patients who had the sham procedure and 23% of those assigned to sphincterotomy had a successful outcome (adjusted risk difference -15.6%; 95% CI, -28.0% to 3.3%, P = 0.01). In the sphincterotomy group, patients with any combination of abnormal sphincter pressures did not benefit differently from those with normal pressures (P = 0.55). Finally, success of either the single or dual sphincterotomy procedures was not related to abnormal pancreatic pressures (P = 0.70).
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