Multicenter prospective randomized controlled clinical trial comparing the pocket-creation method with and without single-clip traction of colonic endoscopic submucosal dissection.

BACKGROUND: The pocket-creation method (PCM) was developed to overcome the technical difficulties of endoscopic submucosal dissection (ESD), although opening the pocket remains challenging. We developed a novel technique of PCM with single-clip traction (PCM-CT), which uses a reopenable clip as a traction device to maintain stability during the procedure. No prospective study has compared the efficacy of PCM-CT and PCM. This study aimed to investigate the effectiveness of PCM-CT vs. PCM in a randomized controlled trial. METHODS: This randomized controlled clinical trial was conducted at four Japanese institutions. Patients with superficial colorectal neoplastic lesions were included following Japanese guidelines for colorectal cancer. Seven moderately experienced endoscopists performed the ESD procedures using either PCM-CT or PCM. RESULTS: 100 patients were enrolled in the study. Compared with PCM, PCM-CT achieved significantly faster mean (SD) dissection speed (21.4 [10.8] vs. 27.0 [14.5] mm2/min [95%CI 0.5 to 10.7], P = 0.03), and reduced the mean procedure time (81.8 [57.9] vs. 64.8 [47.6] minutes [95%CI -38.2 to 4.3], P = 0.12) and pocket-opening time (37.8 [33.0] vs. 30.0 [28.9] minutes [95%CI -20.2 to 4.6], P = 0.22). En bloc and R0 resection rates were not significantly different between the two groups (100% vs. 100%, P >0.99; 100% vs. 96%, P = 0.50, respectively). No significant differences were observed in adverse events between the two groups. CONCLUSION: ESD facilitated by the novel PCM-CT method appeared to be significantly faster than PCM. Both methods achieved high R0 resection rates.

Reopenable clip-over-the-line method for closing large mucosal defects following gastric endoscopic submucosal dissection: Prospective feasibility study.

OBJECTIVES: Large mucosal defects following gastric endoscopic submucosal dissection (ESD) cause postoperative bleeding. To address this limitation and ensure closure of large mucosal defects, we developed the reopenable clip-over-the-line method (ROLM) using a reopenable clip and nylon line. The purpose of this study was to evaluate the feasibility of the ROLM for closure of large mucosal defects following gastric ESD in a prospective, consecutive series of cases. METHODS: We performed the ROLM on 50 consecutive patients with gastric mucosal defects at the Ise Red Cross Hospital and Mie Prefectural Shima Hospital. The time to complete the ROLM, numbers of clips and lines required, size of defect, and closure success rate were measured, and postoperative adverse events were recorded. RESULTS: In all, 50 lesions were included in this study period between July 2021 and March 2022. The success rates of defect closure and defect closure without submucosal dead space of the ROLM were both 100% (50/50), with a median ROLM time of 30 (range, 14-35) min and a median resected specimen major axis of 45 (range, 31-73) mm. The median number of reopenable clips used was 31 (range, 10-93). Following gastric ESD, two cases of post-ESD bleeding were observed during the follow-up periods. CONCLUSION: Our results suggest that ROLM is a feasible strategy for complete closure of mucosal defects post-ESD without submucosal dead space. Future comparative studies with post-ESD bleeding rate as the main outcome are desirable to evaluate the efficacy of ROLM.

Suturing techniques with endoscopic clips and special devices after endoscopic resection.

Endoscopic submucosal dissection is an established method for complete resection of large and early gastrointestinal tumors. However, methods to reduce bleeding, perforation, and other adverse events after endoscopic resection (ER) have not yet been defined. Mucosal defect closure is often performed endoscopically with a clip. Recently, reopenable clips and large-teeth clips have also been developed. The over-the-scope clip enables complete defect closure by withdrawing the endoscope once and attaching the clip. Other methods involve attaching the clip-line or a ring with an anchor to appose the edges of the mucosal defect, followed by the use of an additional clip for defect closure. Since clips are limited by their grasping force and size, other methods, such as endoloop closure, endoscopic ligation with O-ring closure, and the reopenable clip over-the-line method, have been developed. In recent years, techniques often utilized for full-thickness ER of submucosal tumors have been widely used in full-thickness defect closure. Specialized devices and techniques for defect closure have also been developed, including the curved needle and line, stitches, and an endoscopic tack and suture device. These clips and suture devices are applied for defect closure in emergency endoscopy, accidental perforations, and acute and chronic fistulas. Although endoscopic defect closure with clips has a high success rate, endoscopists need to simplify and promote endoscopic closure techniques to prevent adverse events after ER.

Clip-on-clip closure method for a mucosal defect after colorectal endoscopic submucosal dissection: a prospective feasibility study.

BACKGROUND: The closure of mucosal defects after colorectal endoscopic submucosal dissection (ESD) remains difficult. Therefore, various methods and devices have been developed to aid in this procedure. However, a standard method for mucosal defect closure after ESD has not been established. We aimed to examine the efficiency and safety of our clip-on-clip closure method (CCCM) after colorectal ESD. METHODS: The CCCM is a novel method for colorectal mucosal defect closure that uses a conventional clip on the handle of another clip, with the gap as an anchor. The CCCM was prospectively used for closing mucosal defects in 30 patients with 32 lesions after colorectal ESD at the Japanese Ise Red Cross Hospital, Yokkaichi Municipal Hospital, and Medical Corporation Yamashita Hospital between March 2018 and July 2018. Outcome measures were closure success rates of CCCM, procedural closure time, and postoperative adverse events. RESULTS: The median resected specimen size was 34 mm (range 28-73 mm) and the median CCCM defect closure success rate was 97% (31/32). The median procedural time was 8 min (range 3.5-29.2 min), and the median number of clips used was 12 pieces (range 5-20). None of the patients had postoperative adverse events. CONCLUSIONS: CCCM is an efficient, safe, and simple method for the closure of mucosal defects after colorectal ESD that can be performed using only conventional clips.

Feasibility and safety of duodenal covered self-expandable metallic stent fixation: an experimental study.

BACKGROUND AND AIMS: Migration of duodenal covered self-expandable metallic stents (C-SEMS) is the main cause of stent dysfunction in patients with malignant gastric outlet obstruction. However, the ideal method to prevent migration has not been clarified. We aimed to evaluate the feasibility and safety of duodenal C-SEMS fixation in this experimental study. METHODS: We used the over-the-scope clip (OTSC), suture, and clip methods to fix duodenal C-SEMS and evaluated the gripping force of each device and invasion depth based on pathological findings. RESULTS: The OTSC and suturing systems had a significantly higher mean gripping force compared with the clipping system (OTSC vs. clip: 13.2 vs. 1.0 Newtons [N], P < 0.001; suture vs. clip: 8.5 vs. 1.0 N, P < 0.001). OTSC compression was stronger compared with suturing (OTSC vs. suture: 13.2 vs. 8.5 N, P = 0.006). The submucosal layer, but not the muscle layer, was compressed more widely and deeply by OTSC compared with clips based on pathological findings by hematoxylin and eosin staining. CONCLUSION: Both OTSC and suturing methods used for duodenal C-SEMS fixation were feasible compared with the clipping method. The pathological evaluation of invasion depth indicated that OTSC may be safe even for preventive use. This study suggested that these methods can be applied clinically for duodenal C-SEMS fixation.