Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Recruiting now · Phase 3
Conditions studied: Post ERCP Pancreatitis
In brief
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.
Key facts
- Study ID
- NCT03713879
- Run by
- Chinese University of Hong Kong
- People needed
- 1734
- Starts
- 2019-03-21
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-02-12
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- presence of one of the following risk factors for Post ERCP Pancreatitis
- sphincter of Oddi dysfunction
- history of PEP, pancreatic instrumentation or sphincterotomy, precut sphincterotomy,
- difficult cannulation defined by >5 cannulation attempts
- the use of double wire technique in bile duct access
- 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.
You may not qualify if…
- 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 it is running
- Endoscopy centre — Tianjin, Tianjin Municipality, China (enrolling)
- Eastern Hepatobiliary Surgery Hospital,Endoscopy centre — Shanghai, Shanghai Municipality, China (enrolling)
- 2. Chulalongkorn University and King Chulalongkorn Memorial Hospital — Bangkok, Thailand (enrolling)
- Endoscopy centre — Xi'an, Shaanxi, China (enrolling)
- Endoscopy centre — Hangzhou, Zhejiang, China (enrolling)
- Endoscopy Centre, Prince of Wales Hospital — Hong Kong, Hong Kong, Hong Kong (enrolling)
- Endoscopy centre — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.