Pentoxifylline for the Prevention of PEP

Early Phase 1UnknownNCT02992678

Anhui Provincial Hospital110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

110

Conditions

Pancreatitis

Interventions

PentoxifyllineDRUG

Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.

PlaceboDRUG

Placebo, 400 mg, 3 times daily by mouth by mouth the day before ERCP procedure. . Subjects received up to a maximum of 3 doses.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University

Hefei, Anhui, China

RECRUITING

Outcomes

Primary Outcomes

Acute Pancreatitis

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).

Time frame: 24 hours

Secondary Outcomes

The prophylaxis effect of pentoxifylline on post-ERCP pancreatitis in higher risk patients

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).

Time frame: 24 hours

Central Contacts

Shao Feng, MD

CONTACT

8613033090788 tagsmile1985@163.com

Data from ClinicalTrials.gov

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