A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Wakayama Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT01065688
First received: February 8, 2010
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer.


Condition Intervention Phase
Gastric Cancer
Procedure: Roux-en Y reconstruction
Procedure: Billroth-I reconstruction
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Comparing Billroth-I Reconstruction With Roux-en Y Reconstruction After Distal Gastrectomy for Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • the postoperative quality of life (QOL) [ Time Frame: 3 years after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis [ Time Frame: 1, 3 and 5 years after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Roux-en Y
Roux-en Y reconstruction after distal gastrectomy
Procedure: Roux-en Y reconstruction
surgical procedure
Experimental: Billroth-I
Billroth-I reconstruction after distal gastrectomy
Procedure: Billroth-I reconstruction
surgical procedure

Detailed Description:

The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer. There is no prospective randomized study of the two operative procedures focusing on postoperative QOL. The investigators conducted a prospective randomized trial on 120 patients who underwent distal gastrectomy comparing Billroth-I reconstruction and Roux-en Y reconstruction.

The primary endpoint was the postoperative QOL. The secondary endpoints were the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis. Patients were recruited into this study before surgery, on the basis of whether distal gastrectomy was anticipated at Wakayama Medical University Hospital(WMUH) for gastric cancer, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients with history of other organ malignancies, 3) patients who were diagnosed inadequacy for this study by a physician, and 4) patients without an informed consent.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of stomach
  • Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
  • Tumor located in the antrum or the angle or the lower body of stomach
  • Appropriate informed consent was obtained.

Exclusion Criteria:

  • Patients with severe complications which were possible to prolong hospital stay
  • Patients with history of other organ malignancies
  • Patients who were diagnosed inadequacy for this study by a physician
  • Patients without an informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065688

Contacts
Contact: Hiroki Yamaue, MD +81-73-441-0612 yamaue-h@wakayama-med.ac.jp

Locations
Japan
Second Department of Surgery, Wakayama Medical University Recruiting
811-1 Kimiidera, Wakayama, Japan, Wakayama
Contact: Masaki Nakamura, MD    +81-73-441-0613    twins@wakayama-med.ac.jp   
Principal Investigator: Masaki Nakamura, MD         
Sponsors and Collaborators
Wakayama Medical University
Investigators
Principal Investigator: Masaki Nakamura, MD Second Department of Surgery, Wakayama Medical University
  More Information

Publications:
Responsible Party: Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT01065688     History of Changes
Other Study ID Numbers: WMU-GC03
Study First Received: February 8, 2010
Last Updated: September 8, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Wakayama Medical University:
distal gastrectomy
Billroth-I reconstruction
gastric cancer
QOL

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

ClinicalTrials.gov processed this record on August 28, 2014