Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

Pancreatic Cancer Clinical Trial

Official title:

Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01642875
• Other study ID #: PerOsEnteral1
• Status: Recruiting
• Phase: Phase 4
• First received: July 9, 2012
• Last updated: November 22, 2016
• Start date: November 2016
• Est. completion date: December 2020

Study information

• Verified date: November 2016
• Source: Medical University of Warsaw
• Contact: Maciej Slodkowski, MD
• Phone: 0048 22 599 2251
• Email: maciejslodkowski[@]wp.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer of the Duodenum
• Cholangiocarcinoma
• Chronic Pancreatitis
• Duodenal Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Other:
• Enteral nutrition
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.
• Oral nutrition
Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated

Locations

Country	Name	City	State
Poland	Sp Csk Wum	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of delayed gastric emptying		30 days after operation	No
Secondary	Overall morbidity rate		60 days after operation	No
Secondary	Perioperative mortality rate		60 days after operation	No
Secondary	Postoperative hospital stay length		60 days after operation	No
Secondary	Time to full oral nutrition		60 days after operation	No
Secondary	Time to resolution of paralytic ileus		7 days after operation	No
Secondary	Rehospitalization rate		30 days after discharge	No