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Early Jejunostomy Nutrition Minimizes Time to Chemotherapy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Jinling Hospital, China
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Qi Mao, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01766765
First received: January 10, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Jinling Hospital, China:

Primary Outcome Measures:
  • The time to the first adjuvant chemotherapy [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall morbidity rate of jejunostomy nutrition [ Time Frame: 60 days after operation ] [ Designated as safety issue: Yes ]
  • Overall morbidity rate of early oral nutrition [ Time Frame: 60 days after operation ] [ Designated as safety issue: Yes ]
  • Postoperative mortality rate [ Time Frame: 60 days after operation ] [ Designated as safety issue: Yes ]
  • Time to tolerate EJN/EON [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]
  • Time to full oral nutrition [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 10 days after operation ] [ Designated as safety issue: No ]
  • Energy metabolism [ Time Frame: 10 days after operation ] [ Designated as safety issue: No ]
  • Postoperative hospital stay length [ Time Frame: 60 days after operation ] [ Designated as safety issue: No ]
  • Rehospitalization rate [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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