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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.
Background & aim: 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. There are not any standard protocols for nutritional support after major upper gastrointestinal surgery in these patients and postoperative nutritional regimens depend mainly upon surgeon's or center preference.
Patients undergoing pancreatoduodenectomy often begin oral intake a week after operation and enteral or parenteral nutrition is used to cover the daily caloric requirements during this period, although their role still remains questionable. The safety of early oral nutrition has been confirmed in the majority of gastrointestinal procedures. However, pancreatic surgeons are quite reluctant to advance oral diet within the first postoperative week after pancreatoduodenectomy due to fear of anastomosis breakdown or delayed gastric emptying syndrome. These two postoperative nutritional regimens, early oral vs. early enteral nutrition, have not been sufficiently evaluated in a prospective, randomized study.
Material and Methods: 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. The 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.
Purpose: The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EN | Experimental | early enteral nutrition with standard enteral formulas administered through a nasojejunal tube |
|
| PerOs | Active Comparator | early oral nutrition with hospital diets and oral formulas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral nutrition | Other | Standard enteral diet is administered through a nasojejunal tube. Enteral nutrition is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of delayed gastric emptying | 30 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall morbidity rate | 60 days after operation | |
| Perioperative mortality rate | 60 days after operation | |
| Postoperative hospital stay length |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maciej SĊodkowski, MD | Contact | 0048 22 599 2251 | maciejslodkowski@wp.pl | |
| Marek WroĊski, MD | Contact | 0048 22 599 2482 | mwronski@vp.pl |
| Name | Affiliation | Role |
|---|---|---|
| Maciej SĊodkowski, MD | Medical University of Warsaw | Study Director |
| Marek Wronski, MD | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sp Csk Wum | Recruiting | Warsaw | 02-097 | Poland |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D004379 | Duodenal Neoplasms |
| D018281 | Cholangiocarcinoma |
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| D009752 | Nutritional Status |
| D004032 | Diet |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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|
| Oral nutrition | Other | Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated |
|
|
| 60 days after operation |
| Time to full oral nutrition | 60 days after operation |
| Time to resolution of paralytic ileus | 7 days after operation |
| Rehospitalization rate | 30 days after discharge |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010195 | Pancreatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009747 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |