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Patients suffering from pancreas cancer as well as patients with chronic pancreatitis or requiring pancreas surgery often are in a compromised nutritional status. Nutritional support should therefore be started early during the postoperative course to prevent further malnutrition, as it is an important risk factor to develop complications. Recently, several studies have shown that early enteral nutrition (EEN) could shorten length of stay, reduce postoperative infections and mortality, and decrease costs when compared with total parenteral nutrition (TPN) in gastrointestinal cancer surgery. After pancreatoduodenectomy (PD), EEN has been shown to reduce early and late complications, infections, and readmission rates. It is nevertheless currently not clear if EEN improves the short-term outcomes after PD compared to oral nutrition.
The primary objective of the study is to assess the impact of EEN on postoperative morbidity after PD, according to the Comprehensive Complication Index. Secondary objectives are to assess the impact of EEN on major postoperative complications, according to Clavien classification, specific complications, length of stay, readmission rates, quality of life, metabolic stress and nutritional response after PD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early enteral nutrition | Experimental | Intervention group: enteral nutrition from the first postoperative night until 50% of caloric requirements are covered by oral nutrition. Enteral nutrition will start at a flow of 250 ml/12h. If tolerated, enteral nutrition will be increased to 500 ml/12h on postoperative day 1, 750 ml/12h on postoperative day 2, and 1000 ml/12h on postoperative day 3. A hypercaloric enteral nutrition will be used (Isosource Energy Fibre or similar). |
|
| Oral nutrition | No Intervention | Control group: patients will receive standardized oral nutrition. The night after the operation, patients will be allowed to have free drinks. On postoperative day 1, they will receive bouillons, creams, yogurts, and drinks >2 l. On postoperative day 2, they will receive a light diet. On postoperative day 3, they will receive half portion of normal diet and on postoperative day 4 normal diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early enteral nutrition | Dietary Supplement | Enteral nutrition via nasojejunal tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Complication Index | Index measuring all complications for a patient | Postoperative day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Severe postoperative complications | Dindo-Clavien >II | Postoperative day 90 |
| Specific complications after pancreatoduodenectomy | SSI, DGE, POPF, PPH, biliary fistula, gastrojejunal anastomosis fistula, pancreatitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaëtan-Romain Joliat, MD | University of Lausanne Hospitals | Principal Investigator |
| Markus Schäfer, MD | University of Lausanne Hospitals | Study Director |
| Nicolas Demartines, MD | University of Lausanne Hospitals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin-Port Royal, AP-HP | Paris | France | ||||
| Lausanne University Hospital (CHUV) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42018334 | Derived | Joliat GR, Martin D, Labgaa I, Uldry E, Melloul E, Halkic N, Cristaudi A, Majno-Hurst P, Pozza G, Fuks D, Marchese U, Demartines N, Schafer M. Early Enteral vs Oral Postoperative Nutrition After Pancreatoduodenectomy: The NUTRIWHI Randomized Clinical Trial. JAMA Surg. 2026 Jun 1;161(6):575-582. doi: 10.1001/jamasurg.2026.1048. | |
| 35865476 |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Postoperative day 90 |
| Length of stay | From operation day to hospital discharge | Up to 90 days |
| Readmission | Hospital readmission due to surgical complications | Postoperative day 90 |
| Patients' quality of life | EORTC questionnaires | Preoperatively and at 30 and 90 days after the operation |
| Metabolic response to enteral nutrition | Laboratory results | Preoperatively and twice weekly during the first postoperative week |
| Body composition | Bioelectrical impedance analysis | Preoperatively and on the day when patients leave the hospital after the operation |
| Muscular measure | Handgrip strength measure | Preoperatively and on the day when patients leave the hospital after the operation |
| Resting energy expenditure | Indirect calorimetry | On postoperative day 5 |
| Lausanne |
| Canton of Vaud |
| Switzerland |
| Regional Hospital of Lugano | Lugano | Canton Ticino | Switzerland |
| Joliat GR, Martin D, Labgaa I, Melloul E, Uldry E, Halkic N, Fotsing G, Cristaudi A, Majno-Hurst P, Vrochides D, Demartines N, Schafer M. Early enteral vs. oral nutrition after Whipple procedure: Study protocol for a multicentric randomized controlled trial (NUTRIWHI trial). Front Oncol. 2022 Jun 28;12:855784. doi: 10.3389/fonc.2022.855784. eCollection 2022. |