Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
2,600
Rectal Indomethacin was administrated within 30min before ERCP in all patients.
Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
General Hospital of NingXia Medical University
Yinchuan, Ningxia, China
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
No. 451 Hospital
Xi'an, Shaanxi, China
Post-ERCP Pancreatitis
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.
Time frame: 30 days
Moderate-to-severe Pancreatitis
Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).
Time frame: 30 days
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The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Urumqi General Hospital of Lanzhou Military Region
Ürümqi, Xinjiang, China