Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer
NCT05344339 · NA · Ho Chi Minh City, Vietnam
- Condition
- Stomach Cancer
- Disease stage
- Stage I-IV
- Phase
- NA
- Study type
- PROCEDURE
- Intervention
- Distal gastrectomy
- Age
- 18 Years to 80 Years
- Gender
- All
- Sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Research institution
- University Medical Center Ho Chi Minh City (UMC)
- Facility
- University Medical Center Ho Chi Minh City
- Research center
- University Medical Center Ho Chi Minh City
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.
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
Primary outcomes
Reflux esophagistis
Secondary outcomes
Early complications; Operative time; Time for making anastomosis