Esophagus to Small Intestine
Lancet Gastroenterol Hepatol. 2024;9(2):124–32
Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): A multicenter randomized controlled trial
Background: Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is a novel endoscopic method to palliate malignant gastric outlet obstruction. The aim of this study was to assess whether the use of EUS-GE with a double balloon occluder for malignant gastric outlet obstruction could reduce the need for reintervention within 6 months compared with conventional duodenal stenting.
Methods: An international, multicenter, randomized, controlled trial was conducted at 7 sites in Hong Kong, Belgium, Brazil, India, Italy, and Spain. Consecutive patients (aged ≥ 18 years) with malignant gastric outlet obstruction due to unresectable primary gastroduodenal or pancreatobiliary malignancies, a gastric outlet obstruction score (GOOS) of 0 (indicating an inability in intake food or liquids orally), and an Eastern Cooperative Oncology Group performance status score of 3 or lower were included and randomly allocated (1:1) to receive either EUS-GE or duodenal stenting. The primary outcome was the 6-month reintervention rate, defined as the percentage of patients requiring addition-al endoscopic intervention due to stent dysfunction (i.e., restenosis of the stent due to tumor ingrowth, tumor over-growth, or food residue; stent migration; or stent fracture) within 6 months, analyzed in the intention-to-treat popu-lation. Prespecified secondary outcomes were technical success (successful placement of a stent), clinical success (1-point improvement in GOOS within 3 days), adverse events within 30 days, death within 30 days, duration of stent patency, GOOS at 1 month, and quality-of-life scores.
Findings: Between December 1, 2020, and February 28, 2022, 185 patients were screened and 97 (46 men and 51 women) were recruited and randomly allocated (48 to the EUS-GE group and 49 to the duodenal stent group). Mean age was 69.5 years (standard deviation [SD] 12.6) in the EUS-GE group and 64.8 years (SD 13.0) in the duo-denal stent group. All randomly allocated patients completed follow-up and were analyzed. Reintervention within 6 months was required in 2 patients (4%) in the EUS-GE group and 14 (29%) in the duodenal stent group (p = 0.0020; risk ratio = 0.15; 95% confidence interval [CI]: 0.04–0.61). Stent patency was longer in the EUS-GE group (median not reached in either group; hazard ratio = 0.13; 95% CI: 0.08–0.22; log-rank p < 0.0001). 1-month GOOS was sig-nificantly better in the EUS-GE group (mean 2.41 [SD 0.7]) than the duodenal stent group (1.91 [SD 0.9], p = 0.012). There were no statistically significant differences between the EUS-GE and duodenal stent groups in death within 30 days (10 [21%] vs. 6 [12%] patients, respectively, p = 0.286), technical success, clinical success, or quality-of-life scores at 1 month. Adverse events occurred in 11 patients (23%) in the EUS-GE group and in 12 (24%) in the duodenal stent group within 30 days (p = 1.00); 3 cases of pneumonia (2 in the EUS-GE group and 1 in the duodenal stent group) were considered to be procedure related.
Interpretation: In patients with malignant gastric outlet obstruction, endoscopic ultrasonography-guided gastroen-terostomy can reduce the frequency of reintervention, improve stent patency, and result in better patient-reported eating habits compared with duodenal stenting, and the procedure should be used preferentially over duodenal stenting when expertise and required devices are available.