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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

Tracking Information
First Submitted Date  ICMJE September 2, 2008
First Posted Date  ICMJE September 3, 2008
Last Update Posted Date September 4, 2008
Study Start Date  ICMJE April 2002
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2008)
The %body weight ratio [ Time Frame: 12 months after operation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00746161 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2008)
preoperative complication, PNI and QOL score [ Time Frame: within one month, and 3 and 12months after operation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer
Official Title  ICMJE A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Procedure: Reconstruction after total gastrectomy
    Roux-en-Y
  • Procedure: Reconstruction after total gastrectomy
    double tract reconstruction
Study Arms  ICMJE
  • Active Comparator: 1
    Roux-en-Y
    Intervention: Procedure: Reconstruction after total gastrectomy
  • Experimental: 2
    double tract reconstruction
    Intervention: Procedure: Reconstruction after total gastrectomy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2008)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00746161
Other Study ID Numbers  ICMJE WMU-GC02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Second Department of Surgery, Wakayama Medical University
Study Sponsor  ICMJE Wakayama Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Makoto Iwahashi Second Department of Surgery, Wakayama Medical University
PRS Account Wakayama Medical University
Verification Date September 2008

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