International journal of surgery (London, England) · 2025
Reconstruction after distal gastrectomy and alkaline gastritis: a multi-center three-arm randomized trial comparing Billroth-II, Billroth-II Braun, and Uncut Roux-en-Y (SDR-02).
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Seo Hoseok, Son Sang-Yong, Hur Hoon, Park Young Suk, Han Dong-Seok, Lee Han Hong
Аннотация
BACKGROUND: The optimal reconstruction method following distal gastrectomy is crucial for improving postoperative outcomes and quality of life (QOL) in gastric cancer survivors. This study aims to compare three reconstruction methods-uncut Roux-en-Y (R-Y) with Billroth-II (B-II) and B-II Braun-in terms of bile reflux, other endoscopic findings, and QOL.
METHODS: The study was a multi-center, open-label, phase 3 randomized controlled trial conducted across four hospitals. A total of 189 patients were enrolled and randomly assigned to the B-II, B-II Braun, or uncut R-Y groups in a 1:1:1 ratio. The primary endpoint was the incidence of bile reflux at 3 months postoperatively, evaluated via endoscopic examination. Secondary endpoints included additional endoscopic findings and QOL assessments using questionnaires survey.
RESULTS: The operation time was significantly longer in the uncut R-Y group compared to the other groups. There were no significant differences in short-term outcomes among the three groups. The incidence of bile reflux at 3 months was significantly lower in the uncut R-Y group (6.8%) compared to the B-II (77.6%) and B-II Braun (63.6%) groups (p < 0.001). This superiority was sustained at 12 months (10.5% vs. 86.0% vs. 67.9%, respectively; p < 0.001). The uncut R-Y group also exhibited relatively lower rates of alkaline reflux gastritis and epigastric soreness. Dietary intake increased in all three groups from 3 to 12 months postoperatively, with no significant differences between the groups.
CONCLUSIONS: Uncut R-Y is superior to B-II and B-II Braun in reducing bile reflux and related symptoms after distal gastrectomy. These findings support the adoption of uncut R-Y as a preferred reconstruction method for long-term QOL improvement in gastric cancer patients.
REGISTRATION NUMBER: KCTXXXXX (https://cris.nih.go.kr).
METHODS: The study was a multi-center, open-label, phase 3 randomized controlled trial conducted across four hospitals. A total of 189 patients were enrolled and randomly assigned to the B-II, B-II Braun, or uncut R-Y groups in a 1:1:1 ratio. The primary endpoint was the incidence of bile reflux at 3 months postoperatively, evaluated via endoscopic examination. Secondary endpoints included additional endoscopic findings and QOL assessments using questionnaires survey.
RESULTS: The operation time was significantly longer in the uncut R-Y group compared to the other groups. There were no significant differences in short-term outcomes among the three groups. The incidence of bile reflux at 3 months was significantly lower in the uncut R-Y group (6.8%) compared to the B-II (77.6%) and B-II Braun (63.6%) groups (p < 0.001). This superiority was sustained at 12 months (10.5% vs. 86.0% vs. 67.9%, respectively; p < 0.001). The uncut R-Y group also exhibited relatively lower rates of alkaline reflux gastritis and epigastric soreness. Dietary intake increased in all three groups from 3 to 12 months postoperatively, with no significant differences between the groups.
CONCLUSIONS: Uncut R-Y is superior to B-II and B-II Braun in reducing bile reflux and related symptoms after distal gastrectomy. These findings support the adoption of uncut R-Y as a preferred reconstruction method for long-term QOL improvement in gastric cancer patients.
REGISTRATION NUMBER: KCTXXXXX (https://cris.nih.go.kr).