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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01642875
Other study ID # PerOsEnteral1
Secondary ID
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


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
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