Pentoxifylline for the Prevention of PEP

NCT02992678 | Unknown Early Phase 1 DMC

• 1 other identifier: pentoxifylline-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  24 hours

Study Arms (2)

Pentoxifylline

EXPERIMENTAL

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

Drug: Pentoxifylline

Placebo

PLACEBO COMPARATOR

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

Interventions

Pentoxifylline DRUG

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

Pentoxifylline

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, age \> 18 years.
• Normal amylase level before undergoing ERCP.
• Signed inform consent form and agreed to follow-up on time.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

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

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shao Feng, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shao Feng, MD

CONTACT

8613033090788; tagsmile1985@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 14, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)