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

Study Overview
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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.

Official Title
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A Superiority Study for Postoperative Reflux After Distal Gastrectomy With Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis

Conditions
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Gastric Cancer, Postoperative Complications

Intervention / Treatment
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* Procedure: Isoperistaltic Billroth II + Braun anastomosis
* Procedure: Antiperistaltic Billroth II + Braun anastomosis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antiperistaltic<br>In this group patients undergo the distal gestrectomy with antiperistaltic Billroth II + Braun anastomosis | Procedure: Antiperistaltic Billroth II + Braun anastomosis<br>* Laparoscopic distal gestrectomy will be applied with antiperistaltic Billroth II + Braun reconstruction<br>|
| Active Comparator: Isoperistaltic<br>In this group patients undergo the distal gestrectomy with isoperistaltic Billroth II + Braun anastomosis | Procedure: Isoperistaltic Billroth II + Braun anastomosis<br>* Laparoscopic distal gestrectomy will be applied with Isoperistaltic Billroth II + Braun reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Reflux Rate | The rate of bile reflux within 1yrs postoperation | 1 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | 3yrs DFS | 3yrs | 
| Overall survival | 3yrs OS | 3 yrs | 
| Surgery-related reflux gastritis rate | The rate of surgery-related reflux gastritis rate | 1yrs | 
| Surgery-related reflux esophagitis rate | The rate of surgery-related reflux esophagitis rate | 1 yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Gastrectomy, Postoperative Reflux Rate, Gastric Cance, Laparoscopic Surgery