Comparing Indomethacin and Pancreatic Stenting to Prevent Post ERCP Pancreatitis
Comparative Effectiveness Between Rectally Administered Indomethacin and Pancreatic Stenting in the Prevention of Post Endoscopic Retrograde Cholangio-panceaticography (ERCP) Pancreatitis: a Randomized Trial
This study is testing whether giving indomethacin through the rectum or using pancreatic stenting is better at preventing pancreatitis after a procedure called ERCP in patients who are at high risk for this complication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1734 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 7 sites (Xi'an, Shaanxi and 6 other locations) |
| Trial ID | NCT03713879 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of rectally administered indomethacin versus pancreatic duct stenting in preventing post ERCP pancreatitis (PEP) in high-risk patients. PEP is a common complication following endoscopic retrograde cholangiopancreatography (ERCP), and both interventions have shown independent benefits in reducing its incidence. The study will be conducted as a multi-centre randomized controlled trial, enrolling patients with specific risk factors for PEP. By directly comparing these two methods, the trial seeks to determine if one approach is superior or if both are equally effective.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with specific risk factors for post ERCP pancreatitis, such as sphincter of Oddi dysfunction or a history of pancreatitis.
Not a fit: Patients who may not benefit from this study include those with contraindications to NSAIDs, such as active gastrointestinal bleeding or renal failure, and those intended for pancreatic stenting due to strictures.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective method to prevent post ERCP pancreatitis, potentially reducing complications and improving patient outcomes.
How similar studies have performed: Previous studies have shown success with both interventions independently, but this is the first direct comparison between rectal indomethacin and pancreatic duct stenting.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xi'an, Shaanxi and 6 other locations
- Endoscopy centre — Xi'an, Shaanxi, China (Recruiting)
- Eastern Hepatobiliary Surgery Hospital,Endoscopy centre — Shanghai, Shanghai Municipality, China (Recruiting)
- Endoscopy centre — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Endoscopy centre — Tianjin, Tianjin Municipality, China (Recruiting)
- Endoscopy centre — Hangzhou, Zhejiang, China (Recruiting)
- Endoscopy Centre, Prince of Wales Hospital — Hong Kong, Hong Kong, Hong Kong (Recruiting)
- 2. Chulalongkorn University and King Chulalongkorn Memorial Hospital — Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: James LAU, MD — Chinese University of Hong Kong
- Study coordinator: James LAU, MD
- Email: laujyw@surgery.cuhk.edu.hk
- Phone: 35051411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.