JAMA Network reports results from a multicenter, double-blind, sham-controlled randomized clinical trial evaluating endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy in adults with unexplained acute recurrent pancreatitis and pancreas divisum. The trial tested whether the procedure reduces recurrent acute pancreatitis beyond 30 days after randomization, a key time-to-event outcome. Across participants, acute pancreatitis recurrence beyond 30 days occurs in 34.7% (26 of 75) of the ERCP-with-minor-papillotomy group versus 43.8% (32 of 73) in the sham ERCP group. The adjusted hazard ratio is 0.83 (95% CI, 0.49 to 1.41), indicating no statistically significant reduction. For pancreatitis occurring within 30 days, recurrence is 14.7% in the treatment group versus 8.2% in the sham group. In a subsequent reply, investigators address questions about whether anatomical features such as impaired dorsal duct outflow, duct diameter, or a santorinicele modify the treatment effect. Prespecified subgroup analyses do not show significant treatment-by-subgroup interactions, and the study is not powered for subgroup conclusions. The authors note that santorinicele prevalence was 12% using standard and secretin-enhanced MR cholangiopancreatography prior to randomization.
ERCP with Minor Papillotomy Shows No Significant Reduction in Pancreatitis in Divisum Trial
JAMA Network reports results from a multicenter, double-blind, sham-controlled randomized clinical trial evaluating endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy in adul...
- The trial randomly assigns adults with unexplained acute recurrent pancreatitis and pancreas divisum to ERCP with minor papillotomy or sham ERCP.
- Recurrent acute pancreatitis beyond 30 days is 34.7% (26/75) with minor papillotomy vs 43.8% (32/73) with sham ERCP.
- The adjusted hazard ratio for the primary outcome is 0.83 (95% CI, 0.49-1.41).
- Pancreatitis within 30 days occurs in 14.7% of the treatment group vs 8.2% of the sham group.
- Prespecified subgroup analyses by duct diameter and santorinicele do not show significant treatment-by-subgroup interaction, and the study is not powered for subgroup effects.
To the Editor Dr Coté and colleagues reported the Sphincterotomy for Acute Recurrent Pancreatitis (SHARP) trial, a multicenter, double-blind, sham-controlled randomized clinical trial evaluating endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy for adults with unexplained acute recurrent pancreatitis and pancreas divisum. Recurrent acute pancreatitis beyond 30 days occurred in 34.7% of participants (26/75) in the ERCP with minor papillotomy group vs 43.8% of participants (32/73) in the sham ERCP group (adjusted hazard ratio, 0.83 [95% CI, 0.49-1.41]), whereas pancreatitis within 30 days occurred in 14.7% vs 8.2%, respectively.
1 day agoIn Reply We thank Mr Liu and Mr Chen and colleagues for their comments regarding our randomized clinical trial evaluating ERCP with minor papillotomy in patients with pancreas divisum and unexplained acute recurrent pancreatitis. Liu asks whether anatomical features of impaired dorsal duct outflow modified the treatment effect. In prespecified subgroup analyses stratified by duct diameter or a santorinicele (Figure 4 of the article), we did not find significant treatment × subgroup interactions for the primary outcome. As stated in the article’s Discussion section, the study was not powered for these subgroups. Notably, the prevalence of a santorinicele was 12% using a mix of standard and secretin-enhanced magnetic resonance cholangiopancreatography prior to randomization, which is consistent with the radiology literature. In small santorinicele cohorts, outcomes of minor papillotomy for acute pancreatitis and divisum suggest persistent acute pancreatitis clinically, biochemically, or both in 20% to 30% of patients. Therefore, even though a dilated duct or santorinicele is suggestive of a stenotic orifice, it is unlikely that they are sufficient to ensure a clinically significant benefit of minor papillotomy.
1 day agoTo the Editor Dr Coté and colleagues conducted a multicenter, sham-controlled, double-blind randomized clinical trial to address a long-standing practice question in patients with unexplained acute recurrent pancreatitis and pancreas divisum. The primary time-to-event outcome (acute pancreatitis >30 days after randomization) was not significantly reduced with the use of ERCP with minor papillotomy (adjusted hazard ratio, 0.83 [95% CI, 0.49-1.41]).
1 day ago
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