Pentoxifylline Treatment in Acute Pancreatitis (AP)

Overview

About this study

This is a single center randomized, double-blind, placebo-controlled study, to be conducted at Mayo Clinic, Rochester, MN.

The objective of our research is to determine whether inhibition of the tumor necrosis factor- alpha (TNF-a) pathway by Pentoxifylline reduces inflammatory markers in AP and whether it is safe, beneficial and well-tolerated in patients with acute pancreatitis AP. The study will have 2 groups of 75 patients each, all with AP, randomly assigned to either the drug or a placebo, which looks like the drug, for a period of 3 days or until the time they are discharged, if hospital discharge is within 7 days of admission. The levels of markers of inflammation of C-reactive protein (C-RP), Interleukin-6 (IL-6), Interleukin-8 (IL-8) and Tumor Necrosis Factor-alpha (TNF-a) will be measured at baseline and on 5 successive days or until the time of discharge, whichever occurs earlier.

Subjects will be adult patients =18 years or older admitted to the hospital within 72 hours of diagnosis of acute pancreatitis (AP) as defined by at least two of the following: (1) amylase and/or lipase greater than 3x upper limit of normal, (2) characteristic cross-sectional imaging, (3) typical abdominal pain. Enrollment into the study should take place 24 hours of admission.

Determination of group size was based on the previous pilot study to decrease any of the important adverse outcomes, providing for a dropout rate of 10% during the study. During 2012, 263 patients with AP were admitted to this institution, which possesses the needed infrastructure for successful completion of clinical drug intervention trials.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Enrollment within 72 hours of diagnosis of AP
Ability to give informed consent or a legal adult representative LAR able to give informed consent for subject when needed as defined buy LAR use guidelines.
Adult subjects of age ≥ 18 years.

Exclusion Criteria:

Moderate or severe congestive heart failure,
History of seizure disorders or demyelinating disease,
Nursing mothers,
Pregnancy,
History of prior tuberculosis or risk factors for tuberculosis
Evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal failure, chemotherapy within 60 days, and HIV)
Evidence of active hemorrhage,
Paralytic ileus with severe nausea and vomiting.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Santhi Swaroop Vege, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Santhi Swaroop Vege, M.D.

Closed for enrollment

More information

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