1. Initial multicenter experience using a novel endoscopic tack and suture system for challenging GI defect closure and stent fixation (with video)
- Author
-
Louis M. Wong Kee Song, Mainor R. Antillon-Galdamez, Tarek H. Alansari, Stavros N. Stavropoulos, Michael Bejjani, Christopher A Marshall, Prashanth Rau, Vinay Chandrasekhara, Neil B. Marya, Andrew C. Storm, Hemchand Ramberan, Gregory B. Haber, Mouen A. Khashab, Hiroyuki Aihara, Bachir Ghandour, Norio Fukami, Tala Mahmoud, and Barham K. Abu Dayyeh
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,Endoscopy, Gastrointestinal ,Defect closure ,Suture (anatomy) ,Interquartile range ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,CLIPS ,Adverse effect ,Aged ,Retrospective Studies ,Fixation (histology) ,computer.programming_language ,Sutures ,business.industry ,Suture Techniques ,Gastroenterology ,Stent ,Middle Aged ,Surgery ,Treatment Outcome ,Multicenter study ,Female ,Stents ,business ,computer - Abstract
Background and Aims Closure of endoscopic resection defects can be achieved with through-the-scope clips, over-the-scope clips or endoscopic suturing. However, these devices are often limited by their inability to close large, irregular, and difficult to reach defects. Thus, we aimed to assess the feasibility and safety of the novel through-the-scope suture-based closure system that was developed to overcome these limitations. Methods This is a retrospective multicenter study involving 8 centers in the United States. Primary outcomes included feasibility and safety of early use of the device. Secondary outcomes included assessment of need for additional closure devices, prolonged procedure time, and technical feasibility of performing the procedure with an alternative device(s). Results A total of 93 patients (48.4% female) with mean age 63.6 ± 13.1 years were included. Technical success was achieved in 83 patients (89.2%) and supplemental closure was required in 24.7% (n=23) of patients with a mean defect size of 41.6 ± 19.4 mm. Closure with an alternative device was determined to be impossible in 24.7% of patients due to location, size, or shape of the defect. The use of the tack and suture device prolonged the procedure in 8.6% of the cases but was considered acceptable. Adverse events occurred in 2 patients (2.2%) over a duration of follow-up of 34 days (interquartile range: 13-93.5 days) and were mild and moderate in severity. No serious adverse events or procedure-related deaths occurred. Conclusions The novel endoscopic through-the-scope tack and suture system is safe, efficient, and permits closure of large, and irregularly shaped defects that were not possible with predicate devices.
- Published
- 2022
- Full Text
- View/download PDF