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

NCT ID: NCT00746161

Last Updated: 2008-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2008-04-30

Brief Summary

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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

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Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.

Conditions

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Gastric Cancer

Keywords

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total gastrectomy double tract reconstruction gastric cancer Total gastrectomy in patients with gastric cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Roux-en-Y

Group Type ACTIVE_COMPARATOR

Reconstruction after total gastrectomy

Intervention Type PROCEDURE

Roux-en-Y

2

double tract reconstruction

Group Type EXPERIMENTAL

Reconstruction after total gastrectomy

Intervention Type PROCEDURE

double tract reconstruction

Interventions

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Reconstruction after total gastrectomy

Roux-en-Y

Intervention Type PROCEDURE

Reconstruction after total gastrectomy

double tract reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wakayama Medical University

OTHER

Sponsor Role lead

Responsible Party

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Wakayama Medical University

Principal Investigators

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Makoto Iwahashi

Role: PRINCIPAL_INVESTIGATOR

Second Department of Surgery, Wakayama Medical University

Locations

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Second Department of Surgery, Wakayama Medical University

Wakayama, Wakayama, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 19548028 (View on PubMed)

Other Identifiers

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WMU-GC02

Identifier Type: -

Identifier Source: org_study_id