Early Jejunostomy Nutrition Minimizes Time to Chemotherapy

Study Overview
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Brief Summary
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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).

Official Title
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Fast-track Surgery Recovery Program With Early Jejunostomy Nutrition Protocol Minimizes Time to Adjuvant Chemotherapy in Patients Undergoing Laparoscopic Gastrectomy for Gastric Cancer

Conditions
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Chemotherapy, Gastric Cancer, Laparoscopic Surgery

Intervention / Treatment
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* Procedure: Jejunostomy
* Other: Early oral nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early jejunostomy nutrition<br> | Procedure: Jejunostomy<br>* Routine placement of jejunostomy tube following laparoscopic gastrectomy for gastric cancer. Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube<br>|
| Active Comparator: Early oral nutrition<br> | Other: Early oral nutrition<br>* Free oral nutrition as tolerance allows on POD 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to the first adjuvant chemotherapy |  | 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall morbidity rate of jejunostomy nutrition |  | 60 days after operation | 
| Overall morbidity rate of early oral nutrition |  | 60 days after operation | 
| 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 |