search
Back to results

Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Reconstruction after total gastrectomy
Reconstruction after total gastrectomy
Sponsored by
Wakayama Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring total gastrectomy, double tract reconstruction, gastric cancer, Total gastrectomy in patients with gastric cancer

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2
  • Age 80 years or younger
  • No distant metastasis

Exclusion Criteria:

  • Carcinoma in the remnant stomach
  • Stage intravenous (IV)
  • History of laparotomy
  • History of serious heart disease
  • Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more
  • Absence of informed consent

Sites / Locations

  • Second Department of Surgery, Wakayama Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Roux-en-Y

double tract reconstruction

Outcomes

Primary Outcome Measures

The %body weight ratio

Secondary Outcome Measures

preoperative complication, PNI and QOL score

Full Information

First Posted
September 2, 2008
Last Updated
September 3, 2008
Sponsor
Wakayama Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT00746161
Brief Title
Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer
Official Title
A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wakayama Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method
Detailed Description
Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
total gastrectomy, double tract reconstruction, gastric cancer, Total gastrectomy in patients with gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Roux-en-Y
Arm Title
2
Arm Type
Experimental
Arm Description
double tract reconstruction
Intervention Type
Procedure
Intervention Name(s)
Reconstruction after total gastrectomy
Intervention Description
Roux-en-Y
Intervention Type
Procedure
Intervention Name(s)
Reconstruction after total gastrectomy
Intervention Description
double tract reconstruction
Primary Outcome Measure Information:
Title
The %body weight ratio
Time Frame
12 months after operation
Secondary Outcome Measure Information:
Title
preoperative complication, PNI and QOL score
Time Frame
within one month, and 3 and 12months after operation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2 Age 80 years or younger No distant metastasis Exclusion Criteria: Carcinoma in the remnant stomach Stage intravenous (IV) History of laparotomy History of serious heart disease Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more Absence of informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makoto Iwahashi
Organizational Affiliation
Second Department of Surgery, Wakayama Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Department of Surgery, Wakayama Medical University
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19548028
Citation
Iwahashi M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Katsuda M, Ueda K, Yamaue H. Evaluation of double tract reconstruction after total gastrectomy in patients with gastric cancer: prospective randomized controlled trial. World J Surg. 2009 Sep;33(9):1882-8. doi: 10.1007/s00268-009-0109-0.
Results Reference
derived

Learn more about this trial

Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer

We'll reach out to this number within 24 hrs