Early Jejunostomy Nutrition Minimizes Time to Chemotherapy
Fast-track Surgery Recovery Program With Early Jejunostomy Nutrition Protocol Minimizes Time to Adjuvant Chemotherapy in Patients Undergoing Laparoscopic Gastrectomy for Gastric Cancer
1 other identifier
interventional
100
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 gastric-cancer
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2013
CompletedFirst Posted
Study publicly available on registry
January 11, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJanuary 11, 2013
January 1, 2013
1 year
January 10, 2013
January 10, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The time to the first adjuvant chemotherapy
30 days after operation
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
Early jejunostomy nutrition
EXPERIMENTALEarly oral nutrition
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- Primary gastric cancer
- R0 resection
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinling Hospital
Nanjing, Jiangsu, 210002, China
Related Publications (3)
GASTRIC (Global Advanced/Adjuvant Stomach Tumor Research International Collaboration) Group; Paoletti X, Oba K, Burzykowski T, Michiels S, Ohashi Y, Pignon JP, Rougier P, Sakamoto J, Sargent D, Sasako M, Van Cutsem E, Buyse M. Benefit of adjuvant chemotherapy for resectable gastric cancer: a meta-analysis. JAMA. 2010 May 5;303(17):1729-37. doi: 10.1001/jama.2010.534.
PMID: 20442389BACKGROUNDBiagi JJ, Raphael MJ, Mackillop WJ, Kong W, King WD, Booth CM. Association between time to initiation of adjuvant chemotherapy and survival in colorectal cancer: a systematic review and meta-analysis. JAMA. 2011 Jun 8;305(22):2335-42. doi: 10.1001/jama.2011.749.
PMID: 21642686BACKGROUNDOsland E, Yunus RM, Khan S, Memon MA. Early versus traditional postoperative feeding in patients undergoing resectional gastrointestinal surgery: a meta-analysis. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):473-87. doi: 10.1177/0148607110385698. Epub 2011 May 31.
PMID: 21628607BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qi Mao, MD/PhD
Jinling Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Resident
Study Record Dates
First Submitted
January 10, 2013
First Posted
January 11, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
January 11, 2013
Record last verified: 2013-01