近日，美国匹兹堡大学Dhiraj Yadav团队研究了胰腺分裂处小乳头切除术治疗特发性急性胰腺炎的疗效与安全性。相关论文于2026年1月14日发表在《美国医学会志》上。

胰腺分裂被认为是急性胰腺炎的梗阻性病因。观察性数据表明，内镜逆行胰胆管造影术联合小乳头切开术可降低胰腺炎发作风险。尽管该内镜操作在临床实践中广泛应用，但仍缺乏临床试验证据。该研究旨在确定对于病因不明的急性复发性胰腺炎合并胰腺分裂的成年患者，ERCP联合小乳头切开术能否降低急性胰腺炎风险。

研究组进行了一项多中心、假手术对照、双盲随机临床试验，招募了有2次及以上急性胰腺炎发作且合并胰腺分裂的成年患者。排除了存在其他急性胰腺炎病因或合并慢性钙化性胰腺炎的成人患者。试验于2018年9月1日至2024年8月30日在美国和加拿大的21家转诊中心进行。末次随访时间为2025年2月15日。将参与者按1:1比例随机分配至ERCP联合小乳头切开术组或假手术ERCP组。主要结局是随机分组30天后发生急性胰腺炎的情况（作为时间-事件结局）。次要结局包括急性胰腺炎发作频率，以及慢性钙化性胰腺炎、糖尿病和胰腺外分泌功能不全的发生情况。

共148名参与者被随机分组（平均年龄54[SD 19.5]岁；68.2%为女性；95.3%为非西班牙裔/拉丁裔，87.2%为白人；平均终生急性胰腺炎发作次数3[SD 2]次；平均胰管直径2.2[SD 1.3] mm），中位随访时间为34个月（IQR 21.7-45.7个月）。在ERCP联合小乳头切开术组的75名参与者中，26人（34.7%）发生了急性胰腺炎，而假手术ERCP组的73名参与者中有32人（43.8%）发生（校正风险比0.83[95% CI 0.49-1.41]）。急性复发性胰腺炎发作频率的发病率比在ERCP联合小乳头切开术组为0.25（95% CI 0.18-0.34），假手术ERCP组为0.30（95% CI 0.23-0.41）。两组在慢性钙化性胰腺炎（ERCP联合小乳头切开术组4.0% vs 假手术ERCP组2.7%；风险差0.01[95% CI -0.05至0.07]）、糖尿病（分别为15.8% vs 12.8%；风险差0.03[95% CI -0.13至0.19]）以及胰腺外分泌功能不全（7.7% vs 17.2%；风险差-0.10[95% CI -0.27至0.08]）的发生频率和发病率方面均无组间差异。随机分组后30天内发生急性胰腺炎的不良事件在ERCP联合小乳头切开术组（14.7%）比假手术ERCP组（8.2%）更常见（风险差0.06[95% CI -0.04至0.17]）。

研究结果表明，对于病因不明的急性复发性胰腺炎合并胰腺分裂患者，ERCP联合小乳头切开术并不能降低其再次发生急性胰腺炎或出现相关后遗症的风险。

附：英文原文

Title: Minor Papillotomy for Treatment of Idiopathic Acute Pancreatitis With Pancreas Divisum: A Randomized Clinical Trial

Author: Gregory A. Coté, Valerie Durkalski-Mauldin, Evan L. Fogel, Dana C. Moffatt, Andrew Y. Wang, Luis F. Lara, Paul R. Tarnasky, James L. Buxbaum, Sun-Chuan Dai, Sreeni Jonnalagadda, Field F. Willingham, Andrew Ross, Rajesh N. Keswani, Sumant Inamdar, Truptesh H. Kothari, Timothy B. Gardner, Priya A. Jamidar, Srinivas Gaddam, Douglas K. Pleskow, Jeffrey J. Easler, B. Joseph Elmunzer, John Gerard Coneys, J. Shawn Mallery, Daniel S. Strand, Georgios I. Papachristou, Adam Slivka, Prashant Kedia, Ara B. Sahakian, Abdul Kouanda, Anh Phan, April Williams, Dana K. Andersen, Jose Serrano, Dhiraj Yadav, SHARP Consortium, Haley Nitchie, Alexander Waters, Czarinna M. Posadas, Ann J. Manabat, Spencer K. Harris, Charysa Santos, Thiruvengadam Muniraj, Chloe J. Bennett, Rajiv Chhabra, Kimberly Stello, Charles Gabbert, Kevin McGrath, Kenneth E. Fasanella, Kelley Wood, Tina Tomko, Stuart Sherman, Shelly Winslow, Jeffrey Roesgen, Zack Jacob, Anja Rassmann, Lakin Underwood-Jacobs, Chelsea DiBella, Munazza Z. Ullah, Kayla Lopez, Walter Baldeon, Uchechi Okafor, Luke Roberts, Diane Alpine, Melony Ivekovic, Alejandro Vazquez, Melissa Galicia, Suzette E. Schmidt, Penny J. Doughty, Cheryl Shaw, Joseph Meza, Ross C.D. Buerlein, Dushant S. Uppal, Alexander Podboy, Rebecca Torrance

Issue&Volume: 2026-01-14

Abstract:

Importance  Pancreas divisum is implicated as an obstructive cause for acute pancreatitis. Observational data suggest endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy reduces the risk of pancreatitis episodes. Even though this endoscopic procedure is widely used in practice, clinical trials are lacking.

Objective  To determine whether ERCP with minor papillotomy reduces the risk of acute pancreatitis among adults with unexplained acute recurrent pancreatitis and pancreas divisum.

Design, Setting, and Participants  This multicenter, sham-controlled, double-blind randomized clinical trial enrolled adults with 2 or more episodes of acute pancreatitis and pancreas divisum. Adults with other etiologies for acute pancreatitis or concomitant chronic calcific pancreatitis were excluded. The trial was conducted between September 1, 2018, and August 30, 2024, at 21 referral centers in the US and Canada. Last follow-up occurred on February 15, 2025.

Intervention  Participants were randomized in a 1:1 ratio to ERCP with minor papillotomy or sham ERCP.

Main Outcomes and Measures  The primary outcome was development of acute pancreatitis more than 30 days after randomization as a time-to-event outcome. The secondary outcomes included acute pancreatitis episode frequency and development of chronic calcific pancreatitis, diabetes, and exocrine pancreatic dysfunction.

Results  A total of 148 participants were randomized (mean age, 54 [SD, 19.5] years; 68.2% female; 95.3% non-Hispanic or Latino and 87.2% White; mean lifetime acute pancreatitis episodes, 3 [SD, 2]; mean duct diameter, 2.2 [SD, 1.3] mm) and followed up for a median of 34 months (IQR, 21.7-45.7 months). Of the 75 participants in the ERCP with minor papillotomy group, 26 (34.7%) developed acute pancreatitis compared with 32 of 73 participants (43.8%) in the sham ERCP group (adjusted hazard ratio, 0.83 [95% CI, 0.49 to 1.41]). The incidence rate ratio for acute recurrent pancreatitis episode frequency was 0.25 (95% CI, 0.18 to 0.34) in the ERCP with minor papillotomy group vs 0.30 (95% CI, 0.23 to 0.41) in the sham ERCP group. There were no between-group differences in frequency and incidence of chronic calcific pancreatitis (4.0% in the ERCP with minor papillotomy group vs 2.7% in the sham ERCP group; risk difference [RD], 0.01 [95% CI, 0.05 to 0.07]), diabetes (15.8% vs 12.8%, respectively; RD, 0.03 [95% CI, 0.13 to 0.19]), and exocrine pancreatic dysfunction (7.7% vs 17.2%; RD, 0.10 [95% CI, 0.27 to 0.08]). The adverse event of acute pancreatitis within 30 days of randomization occurred more frequently in the ERCP with minor papillotomy group (14.7%) vs the sham ERCP group (8.2%) (RD, 0.06 [95% CI, 0.04 to 0.17]).

Conclusions and Relevance  Among patients with unexplained acute recurrent pancreatitis and pancreas divisum, ERCP with minor papillotomy does not reduce the risk of another episode of acute pancreatitis or related sequelae.

DOI: 10.1001/jama.2025.23988

Source: https://jamanetwork.com/journals/jama/fullarticle/2843866