Malignant gastric outlet obstruction (GOO) is a debilitating symptom experienced by patients with locally advanced pancreatobiliary or gastroduodenal malignancy.¹ As only a small percentage of these malignancies are resectable, palliative measures such as surgical gastrojejunostomy or endoscopic stenting are usually performed to manage GOO.^1,2 Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is a novel non-surgical procedure that simulates a gastrojejunostomy and has been associated with better clinical outcomes compared to duodenal stenting.¹ In a multicenter, randomized, controlled trial led by researchers from The Chinese University of Hong Kong’s Faculty of Medicine, the improved stent patency and a reduction in reinterventions that EUS-GE offers was presented.¹

Malignant GOO is the mechanical malignant blockage of the upper digestive tract, leading to abdominal pain, repeated vomiting, and an inability to consume foods orally, resulting in a general decrease in patients’ quality-of-life.^1,2,3 Conventional treatments for GOO like surgical gastrojejunostomy offer a wide cross-luminal anastomosis, but are highly invasive and incur increased morbidity.^1,2,3 Conversely, endoscopic stenting is less invasive but is associated with a high risk of stent obstruction which requires reintervention.³ The EUS-GE is a novel method that allows endoscopic placement of a stent between the stomach and the duodenum or jejunum, simulating a surgical gastrojejunostomy without incurring the risks of an invasive surgery.^1,3 Prior to the captioned study, no randomized trials had compared the use of EUS-GE and duodenal stent for malignant GOO.^1,3

This international, multicenter, randomized controlled trial was conducted at seven sites across Hong Kong, Belgium, Brazil, India, Italy, and Spain.¹ Adult patients unable to orally consume food or liquid due to malignant GOO and had an Eastern Cooperative Oncology Group performance status (ECOG-PS) score of ≤3 were included in this study.¹ They were randomized 1:1 to receive EPASSassisted EUS-GE (n=48) or an uncovered duodenal stent (n=49) after guidewire cannulation of the obstruction.¹ All randomized participants completed 6 months of follow-up and were assessed on symptoms of obstruction and their quality-of-life.¹

The primary outcome was the 6-month reintervention rate, defined as the percentage of patients requiring additional endoscopic intervention due to stent dysfunction within 6 months of randomization.¹ Causes of stent dysfunctions requiring restenosis included stent migration, stent fracture, tumor ingrowth, tumor overgrowth, or the presence of food residue.¹ The study found that the EUS-GE group had a significantly lower 6-month reintervention rate compared with the duodenal stent group (4% vs. 29%; p=0.002; RR=0.15; 95% CI: 0.04-0.61).¹ Secondary outcomes included technical success (defined as successful placement of the stent), clinical success [defined as at least 1-point improvement in gastric outlet obstruction score (GOOS) within 3 days after stent insertion], 30-day adverse event rate, 30-day mortality, duration of stent patency, post-stent GOOS, and changes in quality-of-life scores.1 Stent patency also lasted longer in the EUS-GE group (HR=0.13; 95% CI: 0.08-0.22; p<0.0001) and they scored better on the 1-month GOOS (mean=2.41; SD=0.7) than the duodenal stent group (mean=1.91; SD=0.9; p=0.012).¹ No statistically significant differences between the two groups were observed in technical success, clinical success, 30-day mortality, or quality-of-life scores at 1 month.¹

The rates of adverse events within 30 days were also similar (p=1.00) with 2 cases of pneumonia in the EUS-GE group and 1 in the duodenal stent group considered to be procedure-related.¹ The use of the EPASS device might also be associated with a longer procedural time which could increase the risk of aspiration pneumonia.¹ Post-hoc analysis revealed that the median procedural time was significantly longer in the EUS-GE group (35 min vs. 19.5 min; p<0.001) but the median length of hospital stay was significantly shorter (4 days vs. 6 days; p=0.013) compared to patients who received the duodenal stent.¹

The advantages of EUS-GE over duodenal stenting in patients with malignant GOO have been affirmed in this randomized trial.¹ In settings where the expertise and required devices are available, EUS-GE should be considered preferentially over duodenal stenting.¹ However, as the EPASS device has yet to become widely available, whether similar outcomes can be reproduced with the free-hand or other device-assisted techniques remains unclear.¹