Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video)

Abstract

Background and aims Endoscopic resections are associated with bleeding and perforation and may be managed with through-the-scope (TTS) clips, over-the-scope clips and endoscopic suturing. The aim of this preclinical study was to compare technical success of closure using a novel TTS tissue helix tack and suture device (X-Tack) to TTS clips in a porcine model.

Materials and methods Four subjects underwent 40 mucosal resections, diameter range 25–50 mm, in the stomach (n = 24) and colon (n = 16). Closures were randomized to X-Tack (n = 24) or clip (n = 16). Animals underwent weekly endoscopic follow-up for 4 weeks.

Results Technical closure with X-Tack was successful in 24 of 24 (100 %) cases and with clips in 13 of 16 cases (81.3 %) (P = 0.0001). One colonic perforation occurred and was successfully managed using X-Tack. The rate of healing was not statistically different between the groups, and all sites healed at 4 weeks including the perforation and were confirmed by histology.

Conclusions Compared to TTS clip, X-Tack is superior for effecting large mucosal defect closure, including durable sealing of full-thickness perforation. There was no difference in rate of healing between devices.

Publication History

Received: 16 September 2020

Accepted: 23 November 2020

Article published online:
12 April 2021

• References

• 1 Raju GS. Closure of defects and management of complications. Gastrointest Endosc Clin N Am 2019; 29: 705-719
• 2 Albeniz E, Alvarez MA, Espinos JC. et al. Clip closure after resection of large colorectal lesions with substantial risk of bleeding. Gastroenterology 2019; 157: 1213-1221.e4
• 3 Sakurai T, Adachi T, Kono M. et al. Prophylactic suturing closure is recommended after endoscopic treatment of colorectal tumors in patients with antiplatelet/anticoagulant therapy. Oncology 2017; 93: 27-29
• 4 Wang ZJ, Li SY, Zhang YH. et al. Endoscopic closure of large colonic perforations with a novel endoscopic clip device: An animal study (with videos). J Gastroenterol Hepatol 2019; 34: 2152-2157
• 5 Watson A, Zuchelli T. Repair of upper-GI fistulas and anastomotic leakage by the use of endoluminal vacuum-assisted closure. VideoGIE 2019; 4: 40-44
• 6 Al-Bawardy B, Rajan E, Wong Kee Song LM. Over-the-scope clip-assisted endoscopic full-thickness resection of epithelial and subepithelial GI lesions. Gastrointest Endosc 2017; 85: 1087-1092
• 7 Lopez-Nava G, Asokkumar R, Rull A. et al. Safety and feasibility of a novel endoscopic suturing device (EndoZip TM) for treatment of obesity: first-in-human study. Obes Surg 2020; 30: 1696-1703
• 8 Tang SJ. Zipper clip closure of colonoscopic perforations. Gastrointest Endosc 2017; 85: 867-869
• 9 Forrest JA, Finlayson ND, Shearman DJ. Endoscopy in gastrointestinal bleeding. Lancet 1974; 2: 394-397
• 10 Hart SG, Staveland LE. Development of NASA-TLX (Task Load Index): Results of empirical and theoretical research. Advance Psychol 1988; 52: 39-183
• 11 Shin EJ, Ko CW, Magno P. et al. Comparative study of endoscopic clips: duration of attachment at the site of clip application. Gastrointest Endosc 2007; 66: 757-761