Pentoxifylline for the Prevention of PEP

Pancreatitis Clinical Trial

Official title:

Prophylactic Treatment Pentoxifylline for the Prevention of Post-ERCP Pancreatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02992678
• Other study ID #: pentoxifylline-001
• Status: Recruiting
• Phase: Phase 0
• First received: December 13, 2016
• Last updated: December 13, 2016
• Start date: December 2016
• Est. completion date: September 2017

Study information

• Verified date: December 2016
• Source: Anhui Provincial Hospital
• Contact: Shao Feng, MD
• Phone: 8613033090788
• Email: tagsmile1985[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatitis

Intervention

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

Locations

Country	Name	City	State
China	Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University	HeFei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No