A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065688
• Other study ID #: WMU-GC03
• Status: Completed
• Phase: Phase 3
• Start date: January 2009
• Est. completion date: November 2013

Study information

• Verified date: October 2018
• Source: Wakayama Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Roux-en Y reconstruction
surgical procedure
• Billroth-I reconstruction
surgical procedure

Locations

Country	Name	City	State
Japan	Second Department of Surgery, Wakayama Medical University	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

References & Publications (4)

Iwahashi M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Katsuda M, Ueda K, Yamaue H. Evaluation of double tract reconstruction after total gastrectomy in patients with gastric cancer: prospective randomized controlled trial. World J Surg. 2009 Sep;33(9):1882-8. doi: 10.1007/s00268-009-0109-0. — View Citation

Ojima T, Iwahashi M, Nakamori M, Nakamura M, Naka T, Ishida K, Ueda K, Katsuda M, Iida T, Tsuji T, Yamaue H. Influence of overweight on patients with gastric cancer after undergoing curative gastrectomy: an analysis of 689 consecutive cases managed by a single center. Arch Surg. 2009 Apr;144(4):351-8; discussion 358. doi: 10.1001/archsurg.2009.20. — View Citation

Ojima T, Iwahashi M, Nakamori M, Nakamura M, Naka T, Katsuda M, Iida T, Hayata K, Yamaue H. Association of allogeneic blood transfusions and long-term survival of patients with gastric cancer after curative gastrectomy. J Gastrointest Surg. 2009 Oct;13(10):1821-30. doi: 10.1007/s11605-009-0973-9. Epub 2009 Aug 5. — View Citation

Ojima T, Iwahashi M, Nakamori M, Nakamura M, Naka T, Katsuda M, Iida T, Tsuji T, Hayata K, Takifuji K, Yamaue H. Clinicopathological characteristics of remnant gastric cancer after a distal gastrectomy. J Gastrointest Surg. 2010 Feb;14(2):277-81. doi: 10.1007/s11605-009-1090-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the postoperative quality of life (QOL)		3 years after operation
Secondary	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