Early Jejunostomy Nutrition Minimizes Time to Chemotherapy

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01766765
• Other study ID #: EEN-001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 10, 2013
• Last updated: January 10, 2013
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2013
• Source: Jinling Hospital, China
• Contact: Qi Mao, MD/PhD
• Phone: +862580860961
• Email: maoqimdphd[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chemotherapy
• Gastric Cancer
• Laparoscopic Surgery
• Stomach Neoplasms

Intervention

Procedure:
• Jejunostomy
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

Other:
• Early oral nutrition
Free oral nutrition as tolerance allows on POD 1.

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jinling Hospital, China	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to the first adjuvant chemotherapy		30 days after operation	No
Secondary	Overall morbidity rate of jejunostomy nutrition		60 days after operation	Yes
Secondary	Overall morbidity rate of early oral nutrition		60 days after operation	Yes
Secondary	Postoperative mortality rate		60 days after operation	Yes
Secondary	Time to tolerate EJN/EON		30 days after operation	No
Secondary	Time to full oral nutrition		30 days after operation	No
Secondary	Body composition		10 days after operation	No
Secondary	Energy metabolism		10 days after operation	No
Secondary	Postoperative hospital stay length		60 days after operation	No
Secondary	Rehospitalization rate		30 days after discharge	No