Affiliation:
1. Endoscopy Division National Cancer Center Hospital Tokyo Japan
2. Cancer Screening Center National Cancer Center Hospital Tokyo Japan
3. Biostatistics Section, Clinical Research Support Office National Cancer Center Hospital Tokyo Japan
4. Division of Endoscopy Shizuoka Cancer Center Shizuoka Japan
Abstract
ObjectivesEndoscopic 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.MethodsThis 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.ResultsWe 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.ConclusionEHS 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.