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Early Jejunostomy Nutrition Minimizes Time to Chemotherapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Qi Mao, Jinling Hospital, China.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766765
First Posted: January 11, 2013
Last Update Posted: January 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Qi Mao, Jinling Hospital, China
  Purpose

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).


Condition Intervention Phase
Gastric Cancer Laparoscopic Surgery Chemotherapy Procedure: Jejunostomy Other: Early oral nutrition Phase 4

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

Resource links provided by NLM:


Further study details as provided by Qi Mao, Jinling Hospital, China:

Primary Outcome Measures:
  • The time to the first adjuvant chemotherapy [ Time Frame: 30 days after operation ]

Secondary Outcome Measures:
  • Overall morbidity rate of jejunostomy nutrition [ Time Frame: 60 days after operation ]
  • Overall morbidity rate of early oral nutrition [ Time Frame: 60 days after operation ]
  • Postoperative mortality rate [ Time Frame: 60 days after operation ]
  • Time to tolerate EJN/EON [ Time Frame: 30 days after operation ]
  • Time to full oral nutrition [ Time Frame: 30 days after operation ]
  • Body composition [ Time Frame: 10 days after operation ]
  • Energy metabolism [ Time Frame: 10 days after operation ]
  • Postoperative hospital stay length [ Time Frame: 60 days after operation ]
  • Rehospitalization rate [ Time Frame: 30 days after discharge ]

Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early jejunostomy nutrition 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
Active Comparator: Early oral nutrition Other: Early oral nutrition
Free oral nutrition as tolerance allows on POD 1.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766765


Contacts
Contact: Qi Mao, MD/PhD +862580860961 maoqimdphd@gmail.com
Contact: Yousheng Li, MD/PhD +862580860137 liys@medmail.com.cn

Locations
China, Jiangsu
Jinling Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210002
Principal Investigator: Qi Mao, MD/PhD         
Sponsors and Collaborators
Jinling Hospital, China
National Natural Science Foundation of China
Investigators
Principal Investigator: Qi Mao, MD/PhD Jinling Hospital, China