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Comparative Study of Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis for Postoperative Reflux

NCT ID: NCT03372681

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Postoperative Complications

Keywords

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Distal Gastrectomy Postoperative Reflux Rate Gastric Cance Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Antiperistaltic

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

Group Type EXPERIMENTAL

Antiperistaltic Billroth II + Braun anastomosis

Intervention Type PROCEDURE

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

Isoperistaltic

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

Group Type ACTIVE_COMPARATOR

Isoperistaltic Billroth II + Braun anastomosis

Intervention Type PROCEDURE

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

Interventions

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Isoperistaltic Billroth II + Braun anastomosis

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

Intervention Type PROCEDURE

Antiperistaltic Billroth II + Braun anastomosis

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minhua Zheng, M.D. PhD.

Role: STUDY_DIRECTOR

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

Central Contacts

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Minhua Zheng, M.D. PhD.

Role: CONTACT

Phone: +86-13564119545

Email: [email protected]

Jing Sun, M.D. PhD.

Role: CONTACT

Phone: +86-13524284622

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 28163716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27067234 (View on PubMed)

Other Identifiers

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ShanghaiMISC-B2+Braun

Identifier Type: -

Identifier Source: org_study_id