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Pentoxifylline for the Prevention of PEP

NCT ID: NCT02992678

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pentoxifylline

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

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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Pentoxifylline

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

Intervention Type 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 Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shao Feng, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shao Feng, MD

Role: CONTACT

Phone: 8613033090788

Email: [email protected]

Facility Contacts

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Shao Feng, MD

Role: primary

Other Identifiers

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pentoxifylline-001

Identifier Type: -

Identifier Source: org_study_id