Clinical trial · Interventional
A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery
A Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed due to low enrollment
Summary
Brief summary (as posted)
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 supplementation combined with resistance training and nutritional education compared to standard of care, consisting of nutritional education alone. This proof of concept study is intended to demonstrate the ability of pre-habilitation to improve patient-related outcomes following pancreatic surgery, specifically postoperative complications. The rationale for using the designated oral nutrient supplementation is to preserve muscle mass, and decrease weight loss.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pancreatitis | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ensure Surgical | Dietary Supplement | — | UNRESOLVED |
| Low-intensity exercise therapy | Other | — | UNRESOLVED |
| Nutrition counseling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Intervention
- description
- Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling
- interventionNames
- Dietary Supplement: Ensure Surgical
- Other: Nutrition counseling
- Other: Low-intensity exercise therapy
- type
- OTHER
- label
- Nutrition Counseling alone
- description
- Subjects randomized to this arm will receive: Dietary counseling along with standard of care procedures.
- interventionNames
- Other: Nutrition counseling
Primary outcomes (1)
- measure
- Postoperative complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 40-89 at the time of study enrollment. 2. Undergoing pancreatectomy for either chronic pancreatitis or pancreatic cancer. 3. Ability and willingness to complete study related documents and activities. Exclusion Criteria: 1. 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). 2. Subject is receiving (or planned to receive) enteral tube feeding or parenteral nutrition at the time of screening or before surgery. 3. Surgery is planned within 7 days of enrollment (i.e., inadequate time to offer the study intervention). 4. Known allergy to soy or milk, which are included in the oral supplement. 5. The inability to refrain from using a non-study oral nutritional supplement or fish oil supplementation (unless prescribed for treatment of hyperlipidemia). 6. Pregnancy, incarceration, or inability to provide written informed consent.
References
Publications (0)
Data not yet available