Sponsor study identifier
interventional
100
1 country
1
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 10, 2013
Actual (reported)January 11, 2013
Actual (reported)April 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The time to the first adjuvant chemotherapy
30 days after operation
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
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
Free oral nutrition as tolerance allows on POD 1.
Jinling Hospital
Nanjing, Jiangsu, 210002, China
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.
Biagi 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.
Qi Mao, MD/PhD
Jinling Hospital, China
First Submitted
January 10, 2013
First Posted
January 11, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
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Osland 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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 11, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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