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Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis

RecruitingPhase 3Ages 18 Years - 99 YearsAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

Post ERCP pancreatitis (PEP) occurs in 4 to 5% of patients and is associated with significant morbidities and occasional mortalities. The use of rectall administered indomethacin and pancreatic duct stent (PDS) placement have independently been proven to reduce PEP. The comparative effectiveness of the two methods has however not been studied. It is argued that in the context of indomethacin, the placement of a PDS is unnecessary. Advocates for PDS insertion however believe that mechanical decompression of the pancreatic duct is critical in the prevention of pancreatitis. The investigators propose a multi-centre randomised controlled trial to compare the use of rectal indomethacin to PDS insertion in high risk patients in the prevention of PEP.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: presence of one of the following risk factors for Post ERCP Pancreatitis 1. sphincter of Oddi dysfunction 2. history of PEP, pancreatic instrumentation or sphincterotomy, precut sphincterotomy, 3. difficult cannulation defined by \>5 cannulation attempts 4. the use of double wire technique in bile duct access 5. at least 2 of the followings including i) female age\<50 ii) 3 pancreatograms iii) acinarization (contrast injection to tail fo pancreas). iv) normal bilirubin; v)guidewire to the tail of pancreas or secondary branches. Exclusion Criteria: * patients intended for pancreatic stenting e.g. those with pancreatic duct strictures, ampullectomy, * without informed consents from patient or next of kin * age \<18 * pregnant or lactating women * patients with altered anatomy except except Billroth I and II gastrectomy * contraindications to the use of NSAIDs such as those with active gastrointestinal bleeding, renal failure (serum creatinine \> 140) * known NSAID allergy * incipient heart failure.
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What it tests

  • pancreatic stenting
  • Indomethacin
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Where

7 sites
Endoscopy centre
Xi'an, China
Eastern Hepatobiliary Surgery Hospital,Endoscopy centre
Shanghai, China
Endoscopy centre
Shanghai, China
Endoscopy centre
Tianjin, China
Endoscopy centre
Hangzhou, China
Endoscopy Centre, Prince of Wales Hospital
Hong Kong, Hong Kong
2. Chulalongkorn University and King Chulalongkorn Memorial Hospital
Bangkok, Thailand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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