Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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There are Billroth-I, Billroth-II, Billroth-II with Braun, and Roux-en-Y reconstruction after distal gastrectomy. Hypothesis: Billroth-II modified method is non-inferior to Roux-en-Y method in terms of reducing reflux esophagitis after distal gastrectomy for gastric cancer patients.

Detailed Description
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Since the first gastrectomy by Theodore Billroth in 1881, this procedure remained a curative treatment for gastric cancer. Reconstruction method after gastrectomy may affect complication rates, post-operative nutritional status, and quality of life (QoL). There are several reconstruction methods for distal gastrectomy, including Billroth I (B-I), Billroth II (B-II), Roux-en-Y (R-Y). B-I and B-II were considered better than R-Y in terms of shorten operation time and lessen blood loss due to technical simplicity. In contrast, R-Y was better in terms of preventing bile reflux and remnant gastritis, which can increase remnant stomach cancer and worsen QoL. However, long term QoL was similar between B-I and R-Y in some randomized controlled trials. Although bile reflux was higher in B-I and B-II groups, remnant gastric cancer was similar between 3 groups in this study. In brief, which one is the ideal reconstruction after distal gastrectomy is still controversial. At our center, reconstruction after distal and sub-total gastrectomy including B-I, B-II, B-II with Braun anastomosis, and R-Y, depended mostly on surgeons' preferences. From 2018, to decrease bile reflux rate while not increasing operation time, we applied modified B-II technique with 3-5 sutures between the afferent loop to the gastric remnant. This study was conducted to evaluate the efficacy of this method by comparing it with the R-Y method.

Official Title
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Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial

Conditions
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Gastric Cancer, Distal Gastrectomy

Intervention / Treatment
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* Procedure: Distal gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients confirmed with gastric cancer Indicated for radical distal gastrectomy (cT1 to cT4a, any N, M0; according to AJCC/UICC 8th TNM staging for gastric cancer) Age from 18- to 80-year-old Agreed to participate in study with written inform consent Exclusion Criteria: Pregnant patients An American Society of Anesthesiology (ASA) score of higher than 4 Concurrent cancer or history of previous other cancers Previous gastrectomy Complications including bleeding, perforation required emergency gastrectomy

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
Interventional Model Description: Open label randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Billroth-II modified<br>An opening will be made at jejunum 25 cm from Treitz's ligament. Another at greater curvature of the stomach right above transected line. A straight stapling device will be used to make isoperistaltic anastomosis at posterior wall of the stomach. After checking for bleeding, common entry hole will be closed using running suture and 3 -5 sutures to attach afferent loop to the remnant stomach | Procedure: Distal gastrectomy<br>* Reconstruction after Distal Gastrectomy<br>|
| Active Comparator: Roux-en-Y<br>Jejunum will be transected 25 to 30 cm from Treitz's ligament. Marginal vessels will be transected if needed to make sure the loop will reach the stomach without tension. Isoperistaltic gastrojejunostomy will be made at posterior wall of the stomach. After checking for bleeding, common entry hole will be closed using running suture. Jejunojejunal mesenteric defect and Petersen's defect will be closed. | Procedure: Distal gastrectomy<br>* Reconstruction after Distal Gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux esophagistis | Findings of reflux esophagitis according to Los Angeles classification via endoscopy | on the 12th month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early complications | Rate of any complications happened intraoperative and 30-days post-operative | 30 days after surgery | 
| Operative time | Time from first incision to finishing abdomen closure, measured by surgical nurse | Intraoperative | 
| Time for making anastomosis | Time from jejunal stapler opening (for B-II) or from jejunal separating (for R-II) to finishing enhancing suture (including duodenal stump enhancement) | Intraoperative | 
| Blood loss | Weighing of sucked blood and gauze, minus weighing of dry gauze | Intraoperative | 
| Length of post-operative hospital stay | Number of days from date of surgery until date of discharge or mortality | 30 days after surgery or until mortality | 
| Post gastrectomy syndromes | Rate of post gastrectomy syndromes after gastrectomy | from 30 days to 1 years after surgery | 
| Bodyweight | Changing of patient's weight at the follow-up time compare to weight before surgery | on the 3rd, 6th, and 12th month after surgery | 
| Serum total protein | Changing of patient's serum total protein at the follow-up time compare to serum protein before surgery | on the 3rd, 6th, and 12th month after surgery | 
| Serum albumin | Changing of patient's serum albumin at the follow-up time compare to serum albumin before surgery | on the 3rd, 6th, and 12th month after surgery | 
| Hemoglobin | Changing of patient's hemoglobin at the follow-up time compare to hemoglobin before surgery | on the 3rd, 6th, and 12th month after surgery | 
| Changing of Gastric remnant gastritis | Grade of gastric remnant gastritis according to RGB classification (for endoscopy) and updated Sydney classification (for histology) | on the 6th, and 12th month after surgery | 
| Changing of Residual food | Grade of Residual food according to RGB classification via endoscopy | on the 6th, and 12th month after surgery | 
| Changing of bile reflux | Finding of bile reflux according to RGB classification via endoscopy | on the 6th, and 12th month after surgery | 
| Changing of GSRS score | Patient's quality of life evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire | on the 3rd, 6th, and 12th month after surgery | 
| 6th month reflux esophagistis | Findings of reflux esophagitis according to Los Angeles classification via endoscopy | on the 6th month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, Distal gastrectomy, Reconstruction, Gastric adenocarcinoma, Roux-en-Y