Prophylactic Treatment Pentoxifylline for the Prevention of Post-ERCP Pancreatitis
Trial Snapshot
- Phase
- Early Phase 1
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Acute Pancreatitis
Study Overview
Brief Summary
Between December 2016 and June 2017, 110 consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be recruited for the study. Patients were randomized using opaque, sealed envelopes containing random numbers assigning them to treat with pentoxifylline (pentoxifylline group) or Placebo (placebo group) for preventing ERCP pancreatitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and females, age > 18 years.
- •Normal amylase level before undergoing ERCP.
- •Signed inform consent form and agreed to follow-up on time.
Exclusion Criteria
- •Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
- •Patients involved in other study within 60 days.
- •Billroth II or Roux-en-Y anatomy
- •Acute pancreatitis.
- •a history of previous ERCP
- •Pregnancy or history of allergy to pentoxifylline
- •Patient treated for arterial hypertension
- •Patient with severe coagulopathy
- •Patient with hyper sensibility of pentoxifylline
- •Nursing mothers
Arms & Interventions
Pentoxifylline
Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.
Intervention: Pentoxifylline (Drug)
Placebo
Placebo, 400 mg, 3 times daily by mouth by mouth the day before ERCP procedure. . Subjects received up to a maximum of 3 doses.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Acute Pancreatitis
Time Frame: 24 hours
If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours, patients also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP (post-ERCP pancreatitis).
Secondary Outcomes
- The prophylaxis effect of pentoxifylline on post-ERCP pancreatitis in higher risk patients(24 hours)