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

Not Applicable

• Conditions: Postoperative Complications; Gastric Cancer
• Interventions: Procedure: Isoperistaltic Billroth II + Braun anastomosis; Procedure: Antiperistaltic Billroth II + Braun anastomosis

• Registration Number: NCT03372681
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-10
• Study First Submitted QC: 2017-12-10
• Last Update Submitted: 2017-12-10
• Study First Posted: 2017-12-14
• Last Update Posted: 2017-12-14
• Study Start: 2018-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isoperistaltic	Isoperistaltic Billroth II + Braun anastomosis	In this group patients undergo the distal gestrectomy with isoperistaltic Billroth II + Braun anastomosis
Antiperistaltic	Antiperistaltic Billroth II + Braun anastomosis	In this group patients undergo the distal gestrectomy with antiperistaltic Billroth II + Braun anastomosis

Primary Outcome Measures

Name	Time	Method
Postoperative Reflux Rate	1 yrs	The rate of bile reflux within 1yrs postoperation

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	3yrs	3yrs DFS
Surgery-related reflux gastritis rate	1yrs	The rate of surgery-related reflux gastritis rate
Surgery-related reflux esophagitis rate	1 yrs	The rate of surgery-related reflux esophagitis rate
Overall survival	3 yrs	3yrs OS