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A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer

W

Wakayama Medical University

Status and phase

Completed
Phase 3

Conditions

Gastric Cancer

Treatments

Procedure: Roux-en Y reconstruction
Procedure: Billroth-I reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT01065688
WMU-GC03

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Roux-en Y
Active Comparator group
Description:
Roux-en Y reconstruction after distal gastrectomy
Treatment:
Procedure: Roux-en Y reconstruction
Billroth-I
Experimental group
Description:
Billroth-I reconstruction after distal gastrectomy
Treatment:
Procedure: Billroth-I reconstruction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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