Clinical trial NCT01766765: Early Jejunostomy Nutrition Minimizes Time to Chemotherapy
Official title: Fast-track Surgery Recovery Program With Early Jejunostomy Nutrition Protocol Minimizes Time to Adjuvant Chemotherapy in Patients Undergoing Laparoscopic Gastrectomy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastric Cancer
Laparoscopic Surgery
Chemotherapy
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2013-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility 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

Primary outcomes:
measure: The time to the first adjuvant chemotherapy
timeFrame: 30 days after operation
Secondary outcomes:
measure: Overall morbidity rate of jejunostomy nutrition
timeFrame: 60 days after operation
measure: Overall morbidity rate of early oral nutrition
timeFrame: 60 days after operation
measure: Postoperative mortality rate
timeFrame: 60 days after operation
measure: Time to tolerate EJN/EON
timeFrame: 30 days after operation
measure: Time to full oral nutrition
timeFrame: 30 days after operation
measure: Body composition
timeFrame: 10 days after operation
measure: Energy metabolism
timeFrame: 10 days after operation
measure: Postoperative hospital stay length
timeFrame: 60 days after operation
measure: Rehospitalization rate
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Qi Mao, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.