Clinical trial · Interventional
Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy
Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative complications often preclude or delay adequate oral nutrition and nutritional support may be required. However, the role of perioperative nutritional supplementation in well-nourished patients remains controversial. The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy. 96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). The EN group will receive standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The PerOs group will receive oral diets beginning from the 2nd postoperative day and oral intake will be advanced as tolerated.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Duodenum | Malignant Duodenal Neoplasm | ALIAS | 0.90 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Chronic Pancreatitis | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enteral nutrition | Other | — | UNRESOLVED |
| Oral nutrition | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EN
- description
- early enteral nutrition with standard enteral formulas administered through a nasojejunal tube
- interventionNames
- Other: Enteral nutrition
- type
- ACTIVE_COMPARATOR
- label
- PerOs
- description
- early oral nutrition with hospital diets and oral formulas
- interventionNames
- Other: Oral nutrition
Primary outcomes (1)
- measure
- Frequency of delayed gastric emptying
- timeFrame
- 30 days after operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary periampullary tumor * R0, R1 resection * Chronic pancreatitis requiring pancreatoduodenectomy Exclusion Criteria: * Metastatic tumor * Locally unresectable tumor * Previous gastric resection * ASA IV-V * Age under 18 years * Preoperative complete parenteral or enteral feeding * Immunosuppressive therapy before operation * Severe malnutrition * Lack of the patient's consent for the trial participation, feeding tube insertion or epidural analgesia
References
Publications (0)
Data not yet available