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Completed

NCT Number: NCT00746161

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

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Second Department of Surgery, Wakayama Medical University

Wakayama, 641-8510, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reconstruction after total gastrectomy

Procedure

Roux-en-Y

Primary outcomes

  1. The %body weight ratio

    Time frame: 12 months after operation

Secondary outcomes

  1. preoperative complication, PNI and QOL score

    Time frame: within one month, and 3 and 12months after operation

Sponsors and collaborators

Lead sponsor

Wakayama Medical University

Other

Registry information

Official study title

A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 3, 2008
Registry last updated
Sep 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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