A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
distal gastrectomy, Billroth-I reconstruction, gastric cancer, QOL
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Roux-en Y reconstruction Type: Procedure
Name: Billroth-I reconstruction Type: Procedure
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
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
Location
Second Department of Surgery, Wakayama Medical University
811-1 Kimiidera, Wakayama, Japan
Status: Recruiting
Contact: Masaki Nakamura, MD - +81-73-441-0613 - twins@wakayama-med.ac.jp
Start Date
January 2009
Completion Date
December 2013
Sponsors
Wakayama Medical University
Source
Wakayama Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page