Background and aims: Limited information is available on long-term outcomes of EUS-guided Gastroenterostomy (EUS-GE) and modifications of Lumen Apposing Metal Stents (LAMS) over time. Methods: All consecutive EUS-GEs for malignant indications between 2020-2024 were enrolled in a single-centre prospective registry (PROTECT, ClinicalTrials.gov NCT04813055). The primary outcomes were EUS-GE dysfunctions and dysfunction-free survival (DyFS) using Kaplan Meier curves. Endoscopic and Radiologic reassessments were used to estimate local modifications and LAMS diameter over time (linear regression). Results: 166 EUS-GEs (age 66 [interquartile range 60-73], male 53.6%, pancreatic cancer 74.1%) were included. A 20mm LAMS dilated to 18mm was used in 98.8%. Technical and Clinical success rates were 98.8 and 95.7%, respectively. Adverse events were registered in 16.3% (procedure-related 7.2%). Over a median follow-up of 128 [64-245] days, symptom recurrence occurred in 11%, but was related to EUS-GE dysfunctions in 13/154 (8.4%) cases, after a median of 209 [85-347] days. All endoscopic reinterventions were successful. Estimated DyFS at 6 and 12 months was 96.7% and 82%, respectively. At endoscopic reevaluations (47 patients, 61 endoscopies), peri-LAMS tissue reactions were observed in 38.3% after 269 [79-390] days, whilst LAMS modifications (mostly ingrowth) in 19.1% after 421 [231-560] days. Radiologic follow-up (89 patients, 168 CT scans) revealed a reduction in LAMS diameter of ≈ 0.21 mm + 0.03 every month (F-test p <.0001). Conclusions: Clinically overt EUS-GE dysfunctions are rare and successfully endoscopically amenable, discouraging scheduled surveillance in malignancies. However, LAMS shows predictable narrowing, sustained by subclinical local reactions, which might inform surveillance in benign indications.
Long-term Outcomes of EUS-guided Gastroenterostomy (LONG-RANGE study): a prospective cohort study tracking symptom recurrence, reintervention timelines and stent modifications over time
Balzano, Gianpaolo;
2026-01-01
Abstract
Background and aims: Limited information is available on long-term outcomes of EUS-guided Gastroenterostomy (EUS-GE) and modifications of Lumen Apposing Metal Stents (LAMS) over time. Methods: All consecutive EUS-GEs for malignant indications between 2020-2024 were enrolled in a single-centre prospective registry (PROTECT, ClinicalTrials.gov NCT04813055). The primary outcomes were EUS-GE dysfunctions and dysfunction-free survival (DyFS) using Kaplan Meier curves. Endoscopic and Radiologic reassessments were used to estimate local modifications and LAMS diameter over time (linear regression). Results: 166 EUS-GEs (age 66 [interquartile range 60-73], male 53.6%, pancreatic cancer 74.1%) were included. A 20mm LAMS dilated to 18mm was used in 98.8%. Technical and Clinical success rates were 98.8 and 95.7%, respectively. Adverse events were registered in 16.3% (procedure-related 7.2%). Over a median follow-up of 128 [64-245] days, symptom recurrence occurred in 11%, but was related to EUS-GE dysfunctions in 13/154 (8.4%) cases, after a median of 209 [85-347] days. All endoscopic reinterventions were successful. Estimated DyFS at 6 and 12 months was 96.7% and 82%, respectively. At endoscopic reevaluations (47 patients, 61 endoscopies), peri-LAMS tissue reactions were observed in 38.3% after 269 [79-390] days, whilst LAMS modifications (mostly ingrowth) in 19.1% after 421 [231-560] days. Radiologic follow-up (89 patients, 168 CT scans) revealed a reduction in LAMS diameter of ≈ 0.21 mm + 0.03 every month (F-test p <.0001). Conclusions: Clinically overt EUS-GE dysfunctions are rare and successfully endoscopically amenable, discouraging scheduled surveillance in malignancies. However, LAMS shows predictable narrowing, sustained by subclinical local reactions, which might inform surveillance in benign indications.
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