Early Jejunostomy Nutrition Minimizes Time to Chemotherapy
Conditions
Gastric Cancer - Laparoscopic Surgery - Chemotherapy
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Jejunostomy Type: Procedure
Name: Early oral nutrition Type: Other
Overall Status
Not yet recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Jinling Hospital
Nanjing, Jiangsu, China
Status: Not yet recruiting
Start Date
April 2013
Completion Date
June 2014
Sponsors
Jinling Hospital, China
Source
Jinling Hospital, China
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page