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Completed

NCT Number: NCT01065688

A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Second Department of Surgery, Wakayama Medical University

Wakayama, 641-8510, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roux-en Y reconstruction

Procedure

surgical procedure

Billroth-I reconstruction

Procedure

surgical procedure

Primary outcomes

  1. the postoperative quality of life (QOL)

    Time frame: 3 years after operation

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Wakayama Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 9, 2010
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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