A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Roux-en Y reconstruction
Billroth-I reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring distal gastrectomy, Billroth-I reconstruction, gastric cancer, QOL
Eligibility 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
Sites / Locations
- Second Department of Surgery, Wakayama Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Roux-en Y
Billroth-I
Arm Description
Roux-en Y reconstruction after distal gastrectomy
Billroth-I reconstruction after distal gastrectomy
Outcomes
Primary Outcome Measures
the postoperative quality of life (QOL)
Secondary Outcome Measures
the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis
Full Information
NCT ID
NCT01065688
First Posted
February 8, 2010
Last Updated
October 6, 2018
Sponsor
Wakayama Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01065688
Brief Title
A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer
Official Title
A Prospective Randomized Controlled Trial Comparing Billroth-I Reconstruction With Roux-en Y Reconstruction After Distal Gastrectomy for Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wakayama Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
distal gastrectomy, Billroth-I reconstruction, gastric cancer, QOL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Roux-en Y
Arm Type
Active Comparator
Arm Description
Roux-en Y reconstruction after distal gastrectomy
Arm Title
Billroth-I
Arm Type
Experimental
Arm Description
Billroth-I reconstruction after distal gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Roux-en Y reconstruction
Intervention Description
surgical procedure
Intervention Type
Procedure
Intervention Name(s)
Billroth-I reconstruction
Intervention Description
surgical procedure
Primary Outcome Measure Information:
Title
the postoperative quality of life (QOL)
Time Frame
3 years after operation
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaki Nakamura, MD
Organizational Affiliation
Second Department of Surgery, Wakayama Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Department of Surgery, Wakayama Medical University
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19911236
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.
Results Reference
background
PubMed Identifier
19655208
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.
Results Reference
background
PubMed Identifier
19548028
Citation
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.
Results Reference
background
PubMed Identifier
19380649
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.
Results Reference
background
PubMed Identifier
34523717
Citation
Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.
Results Reference
derived
PubMed Identifier
26840944
Citation
Nakamura M, Nakamori M, Ojima T, Iwahashi M, Horiuchi T, Kobayashi Y, Yamade N, Shimada K, Oka M, Yamaue H. Randomized clinical trial comparing long-term quality of life for Billroth I versus Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Br J Surg. 2016 Mar;103(4):337-47. doi: 10.1002/bjs.10060. Epub 2016 Feb 3.
Results Reference
derived
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A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer
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