Early Jejunostomy Nutrition Minimizes Time to Chemotherapy

Phase 4

• Conditions: Gastric Cancer; Laparoscopic Surgery; Chemotherapy
• Interventions: Procedure: Jejunostomy; Other: Early oral nutrition

• Registration Number: NCT01766765
• Lead Sponsor: Jinling Hospital, China

Brief Summary

Adjuvant chemotherapy (AC) for gastric cancer is known to improve prognosis, and longer time to AC is associated with worse survival. However, most clinical trials mandate that AC is still to commence within 6 to 8 weeks after surgery consideration for malnutrition, postoperative complications and intolerance of AC. Placement of jejunostomy nutrition tube for enteral nutrition is a common component of these procedures, as a result of superior postoperative organ function, decreased infection rates, and a greater likelihood to complete AC with enteral nutritional support.

Fast-track surgery (FTS) recovery program focuses on enhancing recovery and reducing morbidity. Introduction of FTS concepts are safe, feasible, and can achieve shorter hospital stays and reduced costs. Early postoperative enteral nutrition combined with FTS results in reductions in total complications compared with traditional postoperative feeding practices and does not negatively affect outcomes. However, the benefit of jejunostomy nutrition tube routine placement and combination with FTS is still being debated. Besides, there remains some controversy over the optimal combination of nutrients and duration and timing and routes of feed administration.

The aim of this study was to determine whether FTS with early jejunostomy nutrition (EJN) following laparoscopic gastrectomy for gastric cancer improved postoperative recovery and minimizes time to AC when compared with FTS with early oral nutrition (EON).

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Last Update Submitted: 2013-01-10
• Study First Posted: 2013-01-11
• Last Update Posted: 2013-01-11
• Study Start: 2013-04
• Primary Completion: 2014-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Primary gastric cancer
• R0 resection

Exclusion Criteria

• Metastatic tumor
• Locally unresectable tumor
• Previous gastric/enteral resection
• Age under 18 years or over 70 years
• Preoperative complete parenteral or enteral nutrition
• Neo-adjuvant chemotherapy
• Severe malnutrition
• Lack of the patient's consent for the trial participation, jejunostomy tube insertion or epidural analgesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early jejunostomy nutrition	Jejunostomy	-
Early oral nutrition	Early oral nutrition	-

Primary Outcome Measures

Name	Time	Method
The time to the first adjuvant chemotherapy	30 days after operation

Secondary Outcome Measures

Name	Time	Method
Postoperative mortality rate	60 days after operation
Time to tolerate EJN/EON	30 days after operation
Time to full oral nutrition	30 days after operation
Body composition	10 days after operation
Energy metabolism	10 days after operation
Postoperative hospital stay length	60 days after operation
Rehospitalization rate	30 days after discharge
Overall morbidity rate of early oral nutrition	60 days after operation
Overall morbidity rate of jejunostomy nutrition	60 days after operation

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China