Status:
TERMINATED
A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Abbott Nutrition
Conditions:
Pancreatic Cancer
Chronic Pancreatitis
Eligibility:
All Genders
40-89 years
Phase:
NA
Brief Summary
This is a single center, open label, randomized trial, involving 150 patients undergoing pancreatic surgery. Patients will be randomized at the time of enrollment to receive from 5-7 days of ONS suppl...
Detailed Description
Patients undergoing pancreatic surgery for either chronic pancreatitis or known/suspected pancreatic cancer represent the study population for this clinical trial. Study subjects randomized to one of...
Eligibility Criteria
Inclusion
- Age 40-89 at the time of study enrollment.
- Undergoing pancreatectomy for either chronic pancreatitis or pancreatic cancer.
- Ability and willingness to complete study related documents and activities.
Exclusion
- Severe malnutrition that in the judgment of the patient's supervising physician or an investigator would not permit surgical intervention without preoperative nutritional support (enteral or parenteral).
- Subject is receiving (or planned to receive) enteral tube feeding or parenteral nutrition at the time of screening or before surgery.
- Surgery is planned within 7 days of enrollment (i.e., inadequate time to offer the study intervention).
- Known allergy to soy or milk, which are included in the oral supplement.
- The inability to refrain from using a non-study oral nutritional supplement or fish oil supplementation (unless prescribed for treatment of hyperlipidemia).
- Pregnancy, incarceration, or inability to provide written informed consent.
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03244683
Start Date
August 28 2017
End Date
August 1 2018
Last Update
March 4 2021
Active Locations (1)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210