NCT01065688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at below P25 for phase_3 gastric-cancer

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

4.7 years

First QC Date

February 8, 2010

Last Update Submit

October 6, 2018

Conditions

Gastric Cancer

Keywords

distal gastrectomyBillroth-I reconstructiongastric cancerQOL

Outcome Measures

Primary Outcomes (1)

  • the postoperative quality of life (QOL)

    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

    1, 3 and 5 years after operation

Study Arms (2)

Roux-en Y

ACTIVE COMPARATOR

Roux-en Y reconstruction after distal gastrectomy

Procedure: Roux-en Y reconstruction

Billroth-I

EXPERIMENTAL

Billroth-I reconstruction after distal gastrectomy

Procedure: Billroth-I reconstruction

Interventions

Roux-en Y reconstructionPROCEDURE

surgical procedure

Roux-en Y
Billroth-I reconstructionPROCEDURE

surgical procedure

Billroth-I

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Department of Surgery, Wakayama Medical University

Wakayama, 641-8510, Japan

Location

Related Publications (6)

  • 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.

    PMID: 19911236BACKGROUND

  • 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.

    PMID: 19655208BACKGROUND

  • 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.

    PMID: 19548028BACKGROUND

  • 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.

    PMID: 19380649BACKGROUND

  • 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.

    PMID: 34523717DERIVED

  • 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.

    PMID: 26840944DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Masaki Nakamura, MD

    Second Department of Surgery, Wakayama Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Second Department of Surgery, Wakayama Medical University

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

January 1, 2009

Primary Completion

September 1, 2013

Study Completion

November 1, 2013

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

JP(1)