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

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ClinicalTrials.gov Identifier: NCT00746161
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : September 4, 2008
Sponsor:
Information provided by:
Wakayama Medical University

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: Reconstruction after total gastrectomy Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2002
Actual Primary Completion Date : January 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Roux-en-Y
Procedure: Reconstruction after total gastrectomy
Roux-en-Y

Experimental: 2
double tract reconstruction
Procedure: Reconstruction after total gastrectomy
double tract reconstruction




Primary Outcome Measures :
  1. The %body weight ratio [ Time Frame: 12 months after operation ]

Secondary Outcome Measures :
  1. preoperative complication, PNI and QOL score [ Time Frame: within one month, and 3 and 12months after operation ]


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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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): NCT00746161


Locations
Japan
Second Department of Surgery, Wakayama Medical University
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Wakayama Medical University
Investigators
Principal Investigator: Makoto Iwahashi Second Department of Surgery, Wakayama Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00746161     History of Changes
Other Study ID Numbers: WMU-GC02
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: September 4, 2008
Last Verified: September 2008

Keywords provided by Wakayama Medical University:
total gastrectomy
double tract reconstruction
gastric cancer
Total gastrectomy in patients with gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases