EUS-directed procedures using lumen-apposing metal stent (LAMS) have been proposed as a more effective alternative to enteroscopy-assisted ERCP for patients with post-surgical anatomy. Amongst factors that influence LAMS migration risk, stent fixation has been suggested as a protective factor. For LAMS fixation with a dedicated over-the-scope fixation device, only a proof-of-concept study within the context of EUS-directed transgastric ERCP (EDGE) is available.

The current study aimed to assess the efficacy and safety of single-session EUS-directed procedures with the dedicated over-the-scope fixation device, using a larger international cohort. 

A retrospective multicenter analysis was performed, including consecutive single-session EUS-directed procedures with the Stentfix device from 11 centers. Only 20x10mm LAMS were utilized. Single-session EUS-directed transgastric interventions (EDGI), as well as EDGE and EUS-directed transenteric ERCP (EDEE) were eligible for inclusion. The primary outcome was perprocedural distal LAMS migration and key secondary outcomes included adverse events, employing the AGREE classification, and single-session technical success rates.

Ninety-seven patients undergoing single-session EUS-directed procedures were included (mean age 57.5 [standard deviation (SD) ±11.8] years, 75.3% female) with predominantly a history of Roux-en-Y gastric bypass (86.6%), Roux-en-Y gastrectomy (4.1%) or pancreatoduodenectomy (3.1%). Procedures consisted of EDGE (n=77, 79.4%), EDGI (n=10, 10.3%) and EDEE (n=10, 10.3%). Main indications were stones or sludge (36.1%), cholangitis/sepsis (22.7%) and benign strictures (20.6%). A ‘single-session-first’-approach was used for 83 patients (85.6%), reserving dual-session procedures only for patients where excessive resistance was encountered during duodenoscope insertion.

Perprocedural distal LAMS migration occurred in 1 patient (1.0%), for which endoscopic salvage was performed using through-the-scope suturing (grade IIIa). Adverse events occurred in 15.5% of patients (n=15), consisting of grade I (n=3, 3.1%), grade II (n=2, 5.2%), grade IIIa (n=5, 5.2%), grade IIIb (n=1, 1.0%) and grade IV adverse events (n=1, 1.0%).  Bleeding (n=5, 5.2%) and pain (n=3, 3.1%) where the most frequent adverse events. One proximal LAMS dislocation occurred during duodenoscope retraction and 1 delayed LAMS dislocation occurred >12 hours after successful EDGE completion, which required endoscopic salvage utilizing an esophageal stent (grade IV) and surgical salvage (grade IIIb) respectively. Both patients with immediate (n=1) and delayed (n=1) distal LAMS migration had a history of more extensive gastric surgery beyond Roux-en-Y gastric bypass, consisting of partial gastrectomy and sleeve gastrectomy respectively.

Single-session technical success was achieved in 88.7% in a median procedure duration of 55 min (interquartile range (IQR) 43-73). After a median follow-up of 228 days (IQR 108-393), planned LAMS and Stentfix removal was performed in 68 cases (70.1%), using mainly forceps traction (n=63, 64.9%). The dedicated removal system was employed in 5 cases (5.2%).

In 14 patients, no closure techniques were applied following LAMS removal (14.4%), whereas in 42.3% of patients over-the-scope clip fistula closure was performed (n=43).

Over-the-scope LAMS fixation resulted in a low distal LAMS migration rate for single-session EUS-directed procedures and our data furthermore suggest that this technique might facilitate a ‘single-session-first’-approach in patients undergoing EUS-directed procedures. However, given distal LAMS migrations only occurred in patients with Roux-en-Y gastric bypass and a history of more extensive gastric surgery beyond gastric bypass, alternative approaches might be considered in these specific situations.