Walradt Trent, Szvarca Daniel, Zarrella Sheri, Ryou Marvin
Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts and Harvard Medical School, 75 Francis St, Boston, MA, 02115, USA.
Surg Endosc. 2025 Jan;39(1):649-656. doi: 10.1007/s00464-024-11434-1. Epub 2024 Dec 2.
Endoscopic closure techniques are effective and safe in the management of transmural gastrointestinal defects. However, there is a paucity of data regarding their comparative effectiveness. This study aimed to compare the efficacy and safety of several new-generation, endoscopic closure devices in a pre-clinical model.
We evaluated five commercially available devices: a through-the-scope clip (TTSC), an anchor-pronged TTSC, a suturing device, helical tacking system, and over-the-scope clip. We tested closure strength using an ex-vivo porcine model. Next, live animals underwent 15 mm gastric and colonic perforations followed by immediate endoscopic closure with one of the devices. We assessed technical success, 7-day survival, time to complete closure, and National Aeronautical and Space Administration Task Load Index (NASA-TLX) task load index.
A total of 60 ex-vivo closures were conducted (12 per device). The suturing device achieved a higher closure strength than all other devices (P < 0.05 for all comparisons). Technical success was achieved in 80% of cases, and 9 of 10 animals (90%) survived to 7 days post-closure. The mean procedure time for the suturing device was longer than all other devices (P < 0.05 for all comparisons). The mean procedure time for the anchor-pronged TTSC was also faster than over-the-scope clip (P = 0.04). The total endoscopist NASA-TLX score for the suturing device and helical system were greater than all other devices (P < 0.05 for all comparisons).
Each closure device varies significantly in closure strength, closure time, and ease of use. Optimal device selection will depend on defect size, anatomic location, the viability of the surrounding tissue, and endoscopist/technician expertise.
内镜闭合技术在处理全层胃肠道缺损方面有效且安全。然而，关于它们相对有效性的数据较少。本研究旨在比较几种新一代内镜闭合装置在临床前模型中的疗效和安全性。
我们评估了五种市售装置：经内镜夹（TTSC）、带锚叉的TTSC、缝合装置、螺旋钉合系统和全层内镜夹。我们使用离体猪模型测试闭合强度。接下来，对活体动物进行15毫米的胃和结肠穿孔，然后立即用其中一种装置进行内镜闭合。我们评估技术成功率、7天生存率、完全闭合时间以及美国国家航空航天局任务负荷指数（NASA-TLX）。
共进行了60次离体闭合（每种装置12次）。缝合装置的闭合强度高于所有其他装置（所有比较P < 0.05）。80%的病例取得技术成功，10只动物中有9只（90%）在闭合后存活至7天。缝合装置的平均操作时间比所有其他装置长（所有比较P < 0.05）。带锚叉的TTSC的平均操作时间也比全层内镜夹快（P = 0.04）。缝合装置和螺旋系统的内镜医师总NASA-TLX评分高于所有其他装置（所有比较P < 0.05）。
每种闭合装置在闭合强度、闭合时间和易用性方面有显著差异。最佳装置选择将取决于缺损大小、解剖位置、周围组织的活力以及内镜医师/技术人员的专业知识。
