A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Controlled Trial Comparing Billroth-I Reconstruction With Roux-en Y Reconstruction After Distal Gastrectomy for Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Roux-en Y reconstruction
* Procedure: Billroth-I reconstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Roux-en Y<br>Roux-en Y reconstruction after distal gastrectomy | Procedure: Roux-en Y reconstruction<br>* surgical procedure<br>|
| Experimental: Billroth-I<br>Billroth-I reconstruction after distal gastrectomy | Procedure: Billroth-I reconstruction<br>* surgical procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the postoperative quality of life (QOL) |  | 3 years after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis |  | 1, 3 and 5 years after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal gastrectomy, Billroth-I reconstruction, gastric cancer, QOL