Actively Recruiting
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Led by Chinese University of Hong Kong · Updated on 2025-02-12
1734
Participants Needed
7
Research Sites
406 weeks
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
X
Xijing Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 99 years
- Presence of one or more risk factors for post-ERCP pancreatitis including sphincter of Oddi dysfunction
- History of post-ERCP pancreatitis, pancreatic instrumentation or sphincterotomy, or precut sphincterotomy
- Difficult cannulation defined by more than 5 cannulation attempts
- Use of double wire technique in bile duct access
- At least two of the following: female under 50 years, three pancreatograms, acinarization, normal bilirubin, guidewire to tail of pancreas or secondary branches
You will not qualify if you...
- Patients intended for pancreatic stenting such as those with pancreatic duct strictures or ampullectomy
- Lack of informed consent from patient or next of kin
- Age under 18 years
- Pregnant or lactating women
- Patients with altered anatomy except Billroth I and II gastrectomy
- Contraindications to NSAIDs including active gastrointestinal bleeding or renal failure (serum creatinine over 140)
- Known allergy to NSAIDs
- Incipient heart failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Endoscopy centre
Xi'an, Shaanxi, China, 710000
Actively Recruiting
2
Eastern Hepatobiliary Surgery Hospital,Endoscopy centre
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
3
Endoscopy centre
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
4
Endoscopy centre
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
5
Endoscopy centre
Hangzhou, Zhejiang, China, 310013
Actively Recruiting
6
Endoscopy Centre, Prince of Wales Hospital
Hong Kong, Hong Kong, Hong Kong
Actively Recruiting
7
2. Chulalongkorn University and King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Actively Recruiting
Research Team
J
James LAU, MD
CONTACT
R
RAYMOND TANG, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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