Abstract：
OBJECTIVE: Endoscopic hand suturing (EHS) is a novel technique for closing a mucosal defect after endoscopic submucosal dissection (ESD). We investigated the technical feasibility of colorectal EHS using a modified flexible through-the-scope needle holder.
METHODS: This was a prospective multicenter study conducted at two referral centers between June 2022 and April 2023. This study included colorectal neoplasms 20-50 mm in size located in the sigmoid colon or rectum. A modified flexible through-the-scope needle holder, with an increased jaw width to facilitate needle grasping, was used for colorectal EHS. The primary end-points were sustained closure rate on second-look endoscopy (SLE) performed on postoperative days 3-4 and suturing time for colorectal EHS. Secondary end-points included complete closure rate and delayed adverse events.
RESULTS: We enrolled 20 colorectal neoplasms in 20 patients, including four patients receiving antithrombotic agents. The tumor location was as follows: lower rectum (n = 8), upper rectum (n = 2), rectosigmoid colon (n = 4), and sigmoid colon (n = 6), and the median mucosal defect size was 37 mm (range, 21-65 mm). The complete closure rate was 90% (18/20 [95% confidence interval (CI) 68.3-98.8%]), and the median suturing time was 49 min (range, 23-92 min [95% CI 35-68 min]). Sustained closure rate on SLE was 85% (17/20 [95% CI 62.1-96.8%]). No delayed adverse events were observed.
CONCLUSIONS: EHS demonstrated a high sustained closure rate. Given the long suturing time and technical difficulty, EHS should be reserved for cases with a high risk of delayed adverse events.
METHODS: This was a prospective multicenter study conducted at two referral centers between June 2022 and April 2023. This study included colorectal neoplasms 20-50 mm in size located in the sigmoid colon or rectum. A modified flexible through-the-scope needle holder, with an increased jaw width to facilitate needle grasping, was used for colorectal EHS. The primary end-points were sustained closure rate on second-look endoscopy (SLE) performed on postoperative days 3-4 and suturing time for colorectal EHS. Secondary end-points included complete closure rate and delayed adverse events.
RESULTS: We enrolled 20 colorectal neoplasms in 20 patients, including four patients receiving antithrombotic agents. The tumor location was as follows: lower rectum (n = 8), upper rectum (n = 2), rectosigmoid colon (n = 4), and sigmoid colon (n = 6), and the median mucosal defect size was 37 mm (range, 21-65 mm). The complete closure rate was 90% (18/20 [95% confidence interval (CI) 68.3-98.8%]), and the median suturing time was 49 min (range, 23-92 min [95% CI 35-68 min]). Sustained closure rate on SLE was 85% (17/20 [95% CI 62.1-96.8%]). No delayed adverse events were observed.
CONCLUSIONS: EHS demonstrated a high sustained closure rate. Given the long suturing time and technical difficulty, EHS should be reserved for cases with a high risk of delayed adverse events.
摘要：
目的：内镜手缝合术（EHS）是一种用于在内镜粘膜下剥离术（ESD）后闭合粘膜缺损的新技术。我们使用改良的柔性透镜针固定器研究了结直肠EHS的技术可行性。
方法：这是一项前瞻性多中心研究，于2022年6月至2023年4月在两个转诊中心进行。这项研究包括位于乙状结肠或直肠的20-50毫米大小的结直肠肿瘤。一种改进的柔性透镜针架，增加下巴的宽度，以方便针的抓握，用于结直肠EHS。主要终点是术后第3-4天进行二次内窥镜检查（SLE）的持续闭合率和结直肠EHS的缝合时间。次要终点包括完全闭合率和延迟不良事件。
结果：我们在20例患者中纳入了20例结直肠肿瘤，包括4名接受抗血栓治疗的患者.肿瘤位置如下：直肠下部（n=8），上直肠（n=2），直肠乙状结肠（n=4），和乙状结肠（n=6），中位粘膜缺损大小为37mm(范围，21-65毫米）。完全闭合率为90%(18/20[95%置信区间(CI)68.3-98.8%])，缝合时间中位数为49分钟(范围，23-92分钟[95%CI35-68分钟])。SLE的持续闭合率为85%(17/20[95%CI62.1-96.8%])。未观察到延迟不良事件。
结论：EHS显示出较高的持续闭合率。考虑到缝合时间长、技术难度大,EHS应保留给具有延迟不良事件高风险的病例。
方法：这是一项前瞻性多中心研究，于2022年6月至2023年4月在两个转诊中心进行。这项研究包括位于乙状结肠或直肠的20-50毫米大小的结直肠肿瘤。一种改进的柔性透镜针架，增加下巴的宽度，以方便针的抓握，用于结直肠EHS。主要终点是术后第3-4天进行二次内窥镜检查（SLE）的持续闭合率和结直肠EHS的缝合时间。次要终点包括完全闭合率和延迟不良事件。
结果：我们在20例患者中纳入了20例结直肠肿瘤，包括4名接受抗血栓治疗的患者.肿瘤位置如下：直肠下部（n=8），上直肠（n=2），直肠乙状结肠（n=4），和乙状结肠（n=6），中位粘膜缺损大小为37mm(范围，21-65毫米）。完全闭合率为90%(18/20[95%置信区间(CI)68.3-98.8%])，缝合时间中位数为49分钟(范围，23-92分钟[95%CI35-68分钟])。SLE的持续闭合率为85%(17/20[95%CI62.1-96.8%])。未观察到延迟不良事件。
结论：EHS显示出较高的持续闭合率。考虑到缝合时间长、技术难度大,EHS应保留给具有延迟不良事件高风险的病例。
