Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Recruiting
Phase 3
Interventional Study
Post ERCP Pancreatitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,734 (estimated)
- Sponsor
- Chinese University of Hong Kong · Other
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About This Trial
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 …
Trial Locations
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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 wi…
Contacts