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Early Jejunostomy Nutrition Minimizes Time to Chemotherapy

Primary Purpose

Gastric Cancer, Laparoscopic Surgery, Chemotherapy

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Jejunostomy
Early oral nutrition
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jinling Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early jejunostomy nutrition

Early oral nutrition

Arm Description

Outcomes

Primary Outcome Measures

The time to the first adjuvant chemotherapy

Secondary Outcome Measures

Overall morbidity rate of jejunostomy nutrition
Overall morbidity rate of early oral nutrition
Postoperative mortality rate
Time to tolerate EJN/EON
Time to full oral nutrition
Body composition
Energy metabolism
Postoperative hospital stay length
Rehospitalization rate

Full Information

First Posted
January 10, 2013
Last Updated
January 10, 2013
Sponsor
Jinling Hospital, China
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT01766765
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
Collaborators
National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Laparoscopic Surgery, Chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early jejunostomy nutrition
Arm Type
Experimental
Arm Title
Early oral nutrition
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Jejunostomy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Early oral nutrition
Intervention Description
Free oral nutrition as tolerance allows on POD 1.
Primary Outcome Measure Information:
Title
The time to the first adjuvant chemotherapy
Time Frame
30 days after operation
Secondary Outcome Measure Information:
Title
Overall morbidity rate of jejunostomy nutrition
Time Frame
60 days after operation
Title
Overall morbidity rate of early oral nutrition
Time Frame
60 days after operation
Title
Postoperative mortality rate
Time Frame
60 days after operation
Title
Time to tolerate EJN/EON
Time Frame
30 days after operation
Title
Time to full oral nutrition
Time Frame
30 days after operation
Title
Body composition
Time Frame
10 days after operation
Title
Energy metabolism
Time Frame
10 days after operation
Title
Postoperative hospital stay length
Time Frame
60 days after operation
Title
Rehospitalization rate
Time Frame
30 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Mao, MD/PhD
Phone
+862580860961
Email
maoqimdphd@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yousheng Li, MD/PhD
Phone
+862580860137
Email
liys@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Mao, MD/PhD
Organizational Affiliation
Jinling Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Mao, MD/PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20442389
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.
Results Reference
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PubMed Identifier
21642686
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.
Results Reference
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PubMed Identifier
21628607
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.
Results Reference
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Early Jejunostomy Nutrition Minimizes Time to Chemotherapy

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