Pentoxifylline for the Prevention of PEP

• Sponsor: Anhui Provincial Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02992678
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 12.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatitis	Drug: Pentoxifylline; Drug: Placebo	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Prophylactic Treatment Pentoxifylline for the Prevention of Post-ERCP Pancreatitis
• Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2017
• Anticipated Study Completion Date: Sep 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University	HeFei	Anhui	China	230001

Sponsors and Collaborators

• Anhui Provincial Hospital

Investigators

• Principal Investigator: Shao Feng, MD, Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anhui Provincial Hospital
• ClinicalTrials.gov Identifier: NCT02992678
• Other Study ID Numbers: pentoxifylline-001
• First Posted: Dec 14, 2016
• Last Update Posted: Dec 14, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Pancreatitis; Pentoxifylline

Study Results

No Results Posted as of Dec 14, 2016