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

This study has been completed.
Sponsor:
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00746161
First received: September 2, 2008
Last updated: September 3, 2008
Last verified: September 2008

September 2, 2008
September 3, 2008
April 2002
January 2008   (final data collection date for primary outcome measure)
The %body weight ratio [ Time Frame: 12 months after operation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00746161 on ClinicalTrials.gov Archive Site
preoperative complication, PNI and QOL score [ Time Frame: within one month, and 3 and 12months after operation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer
A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method 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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Procedure: Reconstruction after total gastrectomy
    Roux-en-Y
  • Procedure: Reconstruction after total gastrectomy
    double tract reconstruction
  • Active Comparator: 1
    Roux-en-Y
    Intervention: Procedure: Reconstruction after total gastrectomy
  • Experimental: 2
    double tract reconstruction
    Intervention: Procedure: Reconstruction after total gastrectomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
up to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00746161
WMU-GC02
Yes
Second Department of Surgery, Wakayama Medical University
Wakayama Medical University
Not Provided
Principal Investigator: Makoto Iwahashi Second Department of Surgery, Wakayama Medical University
Wakayama Medical University
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP