Pentoxifylline for the Prevention of PEP

Prophylactic Treatment Pentoxifylline for the Prevention of Post-ERCP Pancreatitis

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 Overview

• Status: Unknown
• Conditions: Pancreatitis
• Intervention / Treatment: Drug: Pentoxifylline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • HeFei, Anhui, China, 230001
      • Recruiting
      • Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pentoxifylline; Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.	Drug: Pentoxifylline; Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.
PLACEBO_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 hours

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): September 1, 2017

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (ESTIMATE): December 14, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 14, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: pentoxifylline-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO