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 additional endoscopic intervention due to stent dysfunction (i.e., restenosis of the stent due to tumor ingrowth, tumor overgrowth, or food residue; stent migration; or stent fracture) within 6 months, analyzed in the intention-to-treat population. Prespecified secondary outcomes were technical success (successful placement of a stent), clinical success (1-point improvement in gastric outlet obstruction score [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 (SD 12.6) in the EUS-GE group and 64.8 years (13.0) in the duodenal stent group. All randomly allocated patients completed follow-up and were analyzed. Reintervention within 6 months was required in 2 (4%) patients 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 ration = 0.3; 95% CI: 0.08–0.22; log-rank p < 0.0001). 1-month GOOS was significantly better in the EUS-GE group (mean 2.41 [SD 0.7]) than the duodenal stent group (1.91 [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, EUS-GE 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.