Long-term Outcomes of EUS-guided Gastroenterostomy (LONG-RANGE study): a prospective cohort study tracking symptoms recurrence, reintervention timelines and stent changes over time

Aims EUS-guided Gastroenterostomy (EUS-GE) represents a recent breakthrough in therapeutic endosonography, with most existing data derived from retrospective studies focused on short-term technical outcomes. Limited information is available on long-term outcomes, the need for reinterventions and modifications of Lumen Apposing Metal Stents (LAMS) over time.

Methods All consecutive EUS-GE performed in a single institution with the Wireless Simplified Technique (WEST) between 2020 and 2024 were enrolled in a prospective registry (PROTECT, ClinicalTrials.gov NCT04813055), with efficacy and safety outcomes assessed every 60 days. The primary outcomes were symptom recurrence after initial clinical success (rate, proportion) and dysfunction-free survival (DyFS) estimated using Kaplan Meier curves. Endoscopic LAMS reassessments were used to calculate the time to first modification of the stent and surrounding tissues, whilst Radiologic imaging was used to estimate the change in stent calibre (linear regression).

Results 164 EUS-GEs (median age 66 [60-74], male 52.4%, malignant indication 99.4% [pancreatic cancer 73.2%, metastatic 58.3%]) were included. A 20 mm LAMS was used in 98.8%, dilated up to 18 mm in 98.8% of cases. Technical and Clinical success rates were 98.8% and 96.3%, respectively. Adverse events (AEs) were registered in 15.2% (procedure-related 6.1%, severe/fatal 3.7%).

Over a median follow-up of 112 [40-190] days, symptom recurrence occurred in 9.1%, but was related to stent dysfunctions in 10/154 (6.5%) cases. Stent dysfunctions happened after a median of 231 [67-321] days from the procedure, all of which (100%) were successfully managed endoscopically. Estimated DyFS at 6 and 12 months was 97.5% and 82.6%, respectively.

Among 38 patients undergoing endoscopic LAMS re-evaluation for different reasons, tissue reactions on the gastric or jejunal side were observed in 34.2% after a median of 190 [33-351] days, and LAMS ingrowth was seen in 13.2% after a median of 421 [250-560] days. A total of 132 CT scans from 75 patients were analyzed, with regression analysis revealing a reduction in LAMS diameter of≈0.25 mm + 0.03 every 2 months (F-test p<.0001)

Conclusions In the natural history of EUS-GE, subclinical LAMS changes and tissue reactions can be frequently detected during follow-up along with a progressive narrowing of LAMS diameter. However, most of these modifications are asymptomatic, with a 6.5% rate of endoscopic reinterventions, all performed successfully. Analysis of these curves may be helpful to plan scheduled reinterventions, especially in cases with benign indication or in long-term survivors.

 

MissingLinkText

Conflicts of Interest

Authors do not have any conflict of interest to disclose.

Publication History

Article published online:
27 March 2025