Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer
- Conditions
- Distal GastrectomyGastric Cancer
- Interventions
- Procedure: Distal gastrectomy
- Registration Number
- NCT05344339
- Lead Sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Roux-en-Y Distal gastrectomy 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. Billroth-II modified Distal gastrectomy 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
- Primary Outcome Measures
Name Time Method Reflux esophagistis on the 12th month after surgery Findings of reflux esophagitis according to Los Angeles classification via endoscopy
- Secondary Outcome Measures
Name Time Method Operative time Intraoperative Time from first incision to finishing abdomen closure, measured by surgical nurse
Early complications 30 days after surgery Rate of any complications happened intraoperative and 30-days post-operative
Post gastrectomy syndromes from 30 days to 1 years after surgery Rate of post gastrectomy syndromes after gastrectomy
Serum total protein on the 3rd, 6th, and 12th month after surgery Changing of patient's serum total protein at the follow-up time compare to serum protein before surgery
Changing of Residual food on the 6th, and 12th month after surgery Grade of Residual food according to RGB classification via endoscopy
6th month reflux esophagistis on the 6th month after surgery Findings of reflux esophagitis according to Los Angeles classification via endoscopy
Time for making anastomosis Intraoperative Time from jejunal stapler opening (for B-II) or from jejunal separating (for R-II) to finishing enhancing suture (including duodenal stump enhancement)
Blood loss Intraoperative Weighing of sucked blood and gauze, minus weighing of dry gauze
Length of post-operative hospital stay 30 days after surgery or until mortality Number of days from date of surgery until date of discharge or mortality
Changing of bile reflux on the 6th, and 12th month after surgery Finding of bile reflux according to RGB classification via endoscopy
Bodyweight on the 3rd, 6th, and 12th month after surgery Changing of patient's weight at the follow-up time compare to weight before surgery
Serum albumin on the 3rd, 6th, and 12th month after surgery Changing of patient's serum albumin at the follow-up time compare to serum albumin before surgery
Hemoglobin on the 3rd, 6th, and 12th month after surgery Changing of patient's hemoglobin at the follow-up time compare to hemoglobin before surgery
Changing of Gastric remnant gastritis on the 6th, and 12th month after surgery Grade of gastric remnant gastritis according to RGB classification (for endoscopy) and updated Sydney classification (for histology)
Changing of GSRS score on the 3rd, 6th, and 12th month after surgery Patient's quality of life evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
Trial Locations
- Locations (1)
University Medical Center Ho Chi Minh City
🇻🇳Ho Chi Minh City, Vietnam