NCT03713879 Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
| NCT ID | NCT03713879 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Post ERCP Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,734 participants |
| Start Date | 2019-03-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,734 participants in total. It began in 2019-03-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
James LAU, MD
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT03713879 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Post ERCP Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03713879 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,734 participants.
Is NCT03713879 currently recruiting?
Yes, NCT03713879 is actively recruiting participants. Contact the research team at laujyw@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT03713879 trial being conducted?
This trial is being conducted at Xi'an, China, Shanghai, China, Shanghai, China, Tianjin, China and 3 additional locations.
Who is sponsoring the NCT03713879 clinical trial?
NCT03713879 is sponsored by Chinese University of Hong Kong. The principal investigator is James LAU, MD at Chinese University of Hong Kong. The trial plans to enroll 1,734 participants.