Enteral Nutrition After Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Cancer of Duodenum; Cancer of Pancreas; Cholangiocarcinoma; Ampulla of Vater Cancer
• Interventions: Other: Saline; Other: Early enteral nutrition; Device: nasojejunal tube insertion; Other: Oral intake

• Registration Number: NCT03150615
• Lead Sponsor: Nanjing Medical University

Brief Summary

Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer. PD is still associated with a relatively a high incidence of delayed gastric emptying. And, there are no acknowledged strategies to avoid DGE. Several feeding strategies have been investigated to cope with this problem. However, there is still no consensus concerning the best nutrition support method after pancreaticoduodenectomy. The purpose of this study is to determine the effect of nutrition support methods on DGE after pancreaticoduodenectomy: early enteral nutrition or total parenteral nutrition.

Patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group), or Saline administration (Saline group), or oral intake only (Natural control). 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 Saline group will receive saline administered through a nasojejunal tube beginning from the 1st postoperative day. Oral intake will not be restricted in all three group.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Primary Completion: 2017-12
• Study Completion: 2018-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients underwent selective pancreaticoduodenectomy Patients ≥18 years old and ≤80 years old Having given written informed consent

Exclusion Criteria

Previous gastric resection or intestinal reconstruction Preoperative complete parenteral or enteral feeding ASA score ≥4 Pregnant women Severe malnutrition Patient who cannot give written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early enteral nutrition	Oral intake	Nasojejunal tube insertion was done intraopratively. Early enteral nutrition with standard enteral formulas administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
Saline Group	nasojejunal tube insertion	Nasojejunal tube insertion was done intraopratively. Saline was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
Saline Group	Saline	Nasojejunal tube insertion was done intraopratively. Saline was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
Early enteral nutrition	nasojejunal tube insertion	Nasojejunal tube insertion was done intraopratively. Early enteral nutrition with standard enteral formulas administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
ERAS Group	nasojejunal tube insertion	Nasojejunal tube insertion was done intraopratively. None was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
ERAS Group	Oral intake	Nasojejunal tube insertion was done intraopratively. None was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.
Early enteral nutrition	Early enteral nutrition	Nasojejunal tube insertion was done intraopratively. Early enteral nutrition with standard enteral formulas administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate.

Primary Outcome Measures

Name	Time	Method
Incident rate of delayed gastric emptying	30 days	DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS.

Secondary Outcome Measures

Name	Time	Method
Pancreatic fistulas	30 days	evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients
Maximum Plasma Concentration fasting plasma GLP-1 level	Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7	Fasting plasma concentration GLP-1 level was monitored
Infectious complications	30 days
Postoperative mortality rate	30 days
Overall morbidity rate	30 days
Rehospitalization rate	60 days
Postoperative hospital stay length	60 days
Evaluation of the severity of the complications	30 days	according to classification of Dindo-Clavien
Hemorrhagic complications	30 days	evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients

Trial Locations

Locations (1)

The first affiliated hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China