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DOI: 10.1055/s-0045-1805554
Using a Novel Clip with Anchoring Prongs for Third-Space Endoscopy and Full-Thickness Defect Closure
Autoren
Aims This study evaluates the performance of a novel rotatable, anchor-pronged through-the-scope endoscopic clip (TTSC) in managing third-space endoscopy and full-thickness defect closure.
Methods We conducted a multicenter, prospective cohort study of the anchor-pronged MANTIS clip (Boston Scientific Corporation, Marlborough, Massachusetts, USA) used at 10 sites in 6 countries (ClinicalTrials.gov number, NCT05653843). Cases involving prophylactic clipping after polypectomy, EMR, or ESD were excluded from the current analysis, which focused solely on more complex indications such as third-space procedures (submucosal myotomy, STER), and full-thickness resection or full-thickness defect closure. The outcomes were 1) complete defect closure without delayed bleeding at the original site, 2) rate of delayed bleeding requiring intervention within 30 days, and 3) incidence of device- or procedure-related serious adverse events (SAEs).
Results Among 49 enrolled participants with 50 lesions, the mean age was 55.6±16.6 (range 23-80) years, and 24 (49.0%) were male. Indications for clipping included myotomy (n=21 lesions, 42.0%, including 11 per oral endoscopic myotomies [POEM], 7 gastric POEM [G-POEM], 1 Zenker POEM [Z-POEM], 2 bariatric endoscopic antral myotomies [BEAM]), bleeding (n=9, 18.0%), full-thickness resection (n=8, 16.0%), submucosal tunneling endoscopic resection (STER; n=6 lesions, 12.0%), endoscopic anti-reflux mucosectomy (ARMS; n=3, 6.0%), duodenal perforation closure or post-ERCP perforation prophylaxis (n=3, 6.0%). Complete defect closure was achieved in 49 (98.0%) lesions. No delayed bleeding occurred by 30 days after the index procedure. Three (6.0%) patients had 4 related SAEs, including colonic fistula bleeding in an ischemic colitis patient (1), submucosal leak in a POEM procedure (1), and septic shock and gastrointestinal mucosal injury associated with a G-POEM procedure (1). All related SAEs resolved by 10 days after onset.
Conclusions The anchor-pronged TTSC demonstrated efficacy in third-space endoscopy and full-thickness defect closure, with high rates of successful defect closure and no delayed bleeding. The rate of SAEs further supports the clip's safety profile, making it a promising tool for managing third-space endoscopy and full-thickness defect closure.
Publikationsverlauf
Artikel online veröffentlicht:
27. März 2025
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