Pancreatitis
Conditions
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.
Interventions
DRUGPentoxifylline
Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.
DRUGPlacebo
Placebo, 400 mg, 3 times daily by mouth by mouth the day before ERCP procedure. . Subjects received up to a maximum of 3 doses.
Sponsors
Anhui Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females, age \> 18 years. 2. Normal amylase level before undergoing ERCP. 3. Signed inform consent form and agreed to follow-up on time.
Exclusion criteria
1. Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent. 2. Patients involved in other study within 60 days. 3. Billroth II or Roux-en-Y anatomy 4. Acute pancreatitis. 5. a history of previous ERCP 6. Pregnancy or history of allergy to pentoxifylline 7. Patient treated for arterial hypertension 8. Patient with severe coagulopathy 9. Patient with hyper sensibility of pentoxifylline 10. Nursing mothers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Pancreatitis | 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
| Measure | Time frame | Description |
|---|---|---|
| The prophylaxis effect of pentoxifylline on post-ERCP pancreatitis in higher risk patients | 24 hours | If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who 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). |
Countries
China
Contacts
Primary ContactShao Feng, MD
Outcome results
None listed