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).

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).