Pentoxifylline for the Prevention of PEP
Primary Purpose
Pancreatitis
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Pentoxifylline
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Males and females, age > 18 years.
- Normal amylase level before undergoing ERCP.
- Signed inform consent form and agreed to follow-up on time.
Exclusion Criteria:
- 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
Sites / Locations
- Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pentoxifylline
Placebo
Arm Description
Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.
Placebo, 400 mg, 3 times daily by mouth by mouth the day before ERCP procedure. . Subjects received up to a maximum of 3 doses.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT02992678
First Posted
December 13, 2016
Last Updated
December 13, 2016
Sponsor
Anhui Provincial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02992678
Brief Title
Pentoxifylline for the Prevention of PEP
Official Title
Prophylactic Treatment Pentoxifylline for the Prevention of Post-ERCP Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Provincial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pentoxifylline
Arm Type
Experimental
Arm Description
Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
Pentoxifylline
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo, 400 mg, 3 times daily by mouth by mouth the day before ERCP procedure. . Subjects received up to a maximum of 3 doses.
Primary Outcome Measure Information:
Title
Acute Pancreatitis
Description
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 Outcome Measure Information:
Title
The prophylaxis effect of pentoxifylline on post-ERCP pancreatitis in higher risk patients
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females, age > 18 years.
Normal amylase level before undergoing ERCP.
Signed inform consent form and agreed to follow-up on time.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shao Feng, MD
Phone
8613033090788
Email
tagsmile1985@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao Feng, MD
Organizational Affiliation
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
City
HeFei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shao Feng, MD
Phone
8613033090788
Email
tagsmile1985@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Pentoxifylline for the Prevention of PEP
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