NCT03372681

Brief Summary

Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the direction of anastomotic peristalsis has also been reported to affect the anastomosis and thus make difference in reflux rate. We design this study to investigate the potential effect and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction in distal gastrectomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable gastric-cancer

Status
unknown

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

First Submitted

Initial submission to the registry

December 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

4 years

First QC Date

December 10, 2017

Last Update Submit

December 10, 2017

Conditions

Gastric CancerPostoperative Complications

Keywords

Distal GastrectomyPostoperative Reflux RateGastric CanceLaparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative Reflux Rate

    The rate of bile reflux within 1yrs postoperation

    1 yrs

Secondary Outcomes (4)

  • Disease-free survival

    3yrs

  • Overall survival

    3 yrs

  • Surgery-related reflux gastritis rate

    1yrs

  • Surgery-related reflux esophagitis rate

    1 yrs

Study Arms (2)

Antiperistaltic

EXPERIMENTAL

In this group patients undergo the distal gestrectomy with antiperistaltic Billroth II + Braun anastomosis

Procedure: Antiperistaltic Billroth II + Braun anastomosis

Isoperistaltic

ACTIVE COMPARATOR

In this group patients undergo the distal gestrectomy with isoperistaltic Billroth II + Braun anastomosis

Procedure: Isoperistaltic Billroth II + Braun anastomosis

Interventions

Isoperistaltic Billroth II + Braun anastomosisPROCEDURE

Laparoscopic distal gestrectomy will be applied with Isoperistaltic Billroth II + Braun reconstruction

Isoperistaltic
Antiperistaltic Billroth II + Braun anastomosisPROCEDURE

Laparoscopic distal gestrectomy will be applied with antiperistaltic Billroth II + Braun reconstruction

Antiperistaltic

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically diagnosed as gastric cancer before surgery
  • Clinical staging: cT1-4aN0-3M0
  • Postoperative evaluation concluded B-II B anastomosis
  • Consent assigned

You may not qualify if:

  • Diagnosed with other malignancies within 2 years
  • Gastric cancer with clinical staging: cT4b or M1
  • Women with pregnancy or breast-feeding
  • Emergency procedures
  • Consent not assigned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Cui LH, Son SY, Shin HJ, Byun C, Hur H, Han SU, Cho YK. Billroth II with Braun Enteroenterostomy Is a Good Alternative Reconstruction to Roux-en-Y Gastrojejunostomy in Laparoscopic Distal Gastrectomy. Gastroenterol Res Pract. 2017;2017:1803851. doi: 10.1155/2017/1803851. Epub 2017 Jan 9.

    PMID: 28163716BACKGROUND

  • In Choi C, Baek DH, Lee SH, Hwang SH, Kim DH, Kim KH, Jeon TY, Kim DH. Comparison Between Billroth-II with Braun and Roux-en-Y Reconstruction After Laparoscopic Distal Gastrectomy. J Gastrointest Surg. 2016 Jun;20(6):1083-90. doi: 10.1007/s11605-016-3138-7. Epub 2016 Apr 11.

    PMID: 27067234BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Minhua Zheng, M.D. PhD.

    MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University

    STUDY DIRECTOR

Central Study Contacts

Minhua Zheng, M.D. PhD.

CONTACT

+86-13564119545zmhtiger@yeah.com

Jing Sun, M.D. PhD.

CONTACT

+86-13524284622sj11788@rjh.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2017

First Posted

December 14, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

December 14, 2017

Record last verified: 2017-12