Introduction

Endoscopic closure of mucosal defects following colorectal endoscopic submucosal dissection (ESD) helps prevent delayed complications. The Sure Clip Traction Band, a recently developed traction device for endoscopic procedures, features a silicone ring attached to the clip's base, allowing for traction between clips. We have developed a traction-band-assisted endoscopic closure (TBEC) method using the Sure Clip Traction Band [1]. In TBEC, tension between the clips at both ends of the mucosal defect narrows the defect, facilitating the placement of additional clips.

Aims & Methods

We conducted a prospective study to evaluate the feasibility of TBEC in colorectal ESD. Patients with 20-50mm colorectal neoplasms were enrolled. Patients underwent TBEC following the completion of ESD. The primary outcome was the complete closure rate. Secondary outcomes included closure time, number of devices required, and complication rate. The sample size was calculated to be 34 cases based on previous data.

Results

Thirty-four patients were enrolled across three institutions. Data are shown as median (IQR), if applicable. The median age was 75 years (72-80), with a male-to-female ratio of 19:15. Lesion locations were the right colon, left colon, and rectum in a ratio of 22:10:2, respectively. The median lesion diameter was 30 mm (25-35). All ESDs achieved en-bloc resection. The complete closure rate was 100% (34/34). The median closure time was 15 minutes (10-22). The number of devices used was one (1-2) traction band and eight (7-10) clips. Procedure-related complications included intraoperative perforation in 5.8% (2/34), delayed bleeding in 2.9% (1/34), and post-ESD electrocoagulation syndrome in 3.1% (1/32, excluding intraoperative perforation).

Conclusion

A high complete closure rate of mucosal defects following colorectal ESD was achieved using TBEC. Further studies are required to verify the efficacy of TBEC in preventing delayed complications.

References

[1] Maehara K, Esaki M, Sumida Y, Fukuda SI, Minoda Y, Ihara E, Akiho H. Complete closure of mucosal defect after colonic endoscopic submucosal dissection using clip with a silicone traction band. Endoscopy. 2022 Dec;54(S 02):E1005-E1006. doi: 10.1055/a-1889-4838. Epub 2022 Aug 4. PMID: 35926530; PMCID: PMC9736829.

Introduction

Colorectal endoscopic submucosal dissection (ESD) has become a widely used endoscopic technique for superficial colorectal tumors resection. ESD has a higher en bloc resection rate particularly for large lesions than endoscopic mucosal resection (EMR). Thus, ESD is associated with a better curability and can facilitate an adequate histological evaluation. However, the high incidence of postoperative adverse events, such as delayed bleeding, delayed perforation, and post-ESD electrocoagulation syndrome (PECS), which are associated with larger mucosal defects after ESD, has been a cause of concern. Recent meta-analyses have reported that the incidence of postoperative adverse events after ESD was higher than that after EMR.¹ Therefore, these events should be controlled. Various closure techniques have been used to close larger mucosal defects in ESD.² However, the efficacy of these closure techniques in preventing adverse events remains controversial. Furthermore, few studies have been conducted to evaluate a single closure technique with a substantial number of cases.
In some cases, closure of mucosal defects after colorectal ESD is performed using a double-layered suturing technique with conventional hemostatic clips.³ In this technique, the muscle layer is first grasped directly with clips and tented inward, and then the mucosal layer is closed. Therefore, this technique has the potential to provide more reliable closure and prevent the spread of inflammation and abdominal pain than methods that merely close the mucosal layer.

Aims & Methods

This study retrospectively evaluated the impact of closure using a double-layered suturing technique on postoperative adverse events.
In total, 370 lesions in 317 patients who underwent colorectal ESD were included in this analysis. Then, patients with 197 lesions that were completely closed were assigned to the closure group. Meanwhile, patients with 173 lesions including 55 that were partially closed and 118 that were not closed were assigned to the non-closure group. Propensity score matching was performed and 136 lesions were selected for each group.

Results

The closure group had a significantly lower overall incidence rate of postoperative adverse events including delayed bleeding, delayed perforation and post-ESD electrocoagulation syndrome than the non-closure group (2.2% vs. 9.6%, p = 0.018). The closure group had a significantly lower incidence of abdominal pain on the day after ESD than the non-closure group (2.9% vs. 11.0%, p = 0.015).

Conclusion

Prophylactic closure of mucosal defects after colorectal ESD using a double-layered suturing technique could prevent postoperative adverse events and abdominal pain on the day after ESD.

References

1 Wang N, Shu L, Liu S, et al. Comparing endoscopic mucosal resection with endoscopic submucosal dissection in colorectal adenoma and tumors: Meta-analysis and system review. PLoS One 2023;18:e0291916.
2 Kobara H, Tada N, Fujihara S, Nishiyama N, Masaki T. Clinical and technical outcomes of endoscopic closure of postendoscopic submucosal dissection defects: Literature review over one decade. Dig Endosc 2023;35:216-231.
3 Tanaka S, Toyonaga T, Obata D, Ishida T, Morita Y, Azuma T. Endoscopic double-layered suturing: a novel technique for closure of large mucosal defects after endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). Endoscopy 2012;44 Suppl 2 UCTN:E153-154.

Introduction

Colorectal endoscopic submucosal dissection (C-ESD) has been established as a standard treatment for colorectal neoplasms which need to be resected in an en bloc fashion. However, the dissection of thin submucosa under inadequate visualization is still technically demanding. A traction device is a key to this problem.

Aims & Methods

We recently developed a novel traction device (multi-loop traction device, MLTD; Boston Scientific Co. Ltd., Tokyo, Japan). The present study focuses on evaluating the effectiveness and safety of MLTD during C-ESD. A multicenter randomized controlled trial was conducted involving patients aged 20 years or older with colorectal lesions (≥ 20 mm) suspected of non-invasive carcinoma. Participants were randomly assigned in 1:1 ratio to undergo ESD with MLTD (MLTD-ESD group) or without any traction device (control group). In both groups, the operators were given the option to convert the treatment to the other group if endoscopist found it difficult to continue treatment under the conditions given in each group for more than 10 minutes. The primary endpoint was dissection speed, with key secondary endpoints being technical success rate and adverse events. The technical success rate was defined as the proportion of cases in which the protocol treatment was completed in each group.

Results

A total of 108 participants were randomized into the MLTD-ESD group (n = 53) and the control group (n = 55). Median dissection speeds were not significantly different between the MLTD-ESD group and the control group (14.8 [IQR: 8.9-23.9] vs. 13.3 [IQR: 8.9-18.8] mm²/min; P = 0.30). However, the technical success rate was significantly higher in the MLTD-ESD group (96.2%) compared to the control group (71.0%). There were two cases in which treatment was converted in the MLTD-ESD group, and 16 cases in which treatment was converted in the control group. There was no significant difference between the MLTD-ESD group and the control group in the en bloc resection rate (98.1% vs. 100%, P = 0.31), R0 resection rate (94.3% vs. 91.0%, P = 0.46) and the incidence of adverse events (7.5% vs. 9.1%, P = 0.77). Two intraoperative perforations, one delayed bleeding, and one delayed perforation occurred in the MLTD-ESD group. All patients recovered with nonsurgical management. The subgroup analysis among expert endoscopists with over 200 clinical ESD experiences showed a faster dissection speed in the MLTD-ESD group compared to the control group (21.6 [IQR: 15.5-28.8] vs. 14.4 [IQR: 9.9-21.2] mm²/min; P = 0.009).

Conclusion

The use of MLTD did not lead to a faster dissection speed during C-ESD in this multicenter randomized controlled trial. However, it was associated with a higher technical success rate, and faster ESD procedures among expert endoscopists. To better define its role in C-ESD, further research with a more targeted approach is warranted.

Disclosure

Kazuki Sumiyama is named as an inventor in patent licensing of the “Multi-Loop Traction Device.”

Introduction

Prophylactic clip closure is known to avoid delayed adverse events post colorectal endoscopic submucosal dissection (ESD).¹ It may also improve reduce the duration of hospitalization.² However, endoscopic clips have limitation of defect size that can be completely closed due to their limited opening width. Other studies have suggested methods to completely close a mucosal defect using special devices^{3, 4} which have limitations of availability, learning curve, scope removal and reinsertion, and negotiation in narrow spaces. An ideal closure technique has been described as a technique which is technically easy, requiring no special accessories or endoscopes, managed through accessory channel without endoscope removal, possible in narrow space, creating no dead space, and being economical.⁵ We recently developed a Clip with Line Pulley Securing (CLiPS) technique to completely close large mucosal defect which fulfils the criteria for an ideal closure technique.⁶

Aims & Methods

The aim of this study was to report the feasibility and efficacy of CLiPS technique for closure of large mucosal defects following colorectal ESD. This study retrospectively evaluated 53 consecutive patients who underwent closure using CLiPS technique post colorectal ESD. CLiPS technique involves deployment of a clip with nylon line on the edges of the ulcer which are approximated using external counter traction. An endoloop is deployed to fix the line. The principle is supporting the clip line with an endoloop and creating a pulley system by giving external countertraction to the line, to facilitate a strong, stable approximation of edges, thereby making the defect more linear. The line is cut and final closure is completed with conventional clips. The primary outcomes were complete closure rate and adverse events. The secondary outcomes were closure time and defect size.

Results

The lesion characteristics are given in the 'table'. Complete closure was achieved in 94.3%(50/53) of cases. The mean defect size was 48.2­+18.8 mm and median closure time was 14(5-58) minutes. There was one case each of delayed bleeding and perforation which were managed by endoscopic clipping.

Conclusion

CLiPS technique has reasonable outcomes and can be considered to be a safe and effective closure method for large post ESD colorectal defects. Further prospective study may be undertaken to establish wider acceptability of this method.

References

1. Liu M, Zhang Y, Wang Y, et al. Effect of prophylactic closure on adverse events after colorectal endoscopic submucosal dissection: A meta‐analysis. Journal of Gastroenterology and Hepatology. 2020 Nov;35(11):1869-77.
2. Abe S, Saito Y, Tanaka Y, et al. A novel endoscopic hand-suturing technique for defect closure after colorectal endoscopic submucosal dissection: a pilot study. Endoscopy. 2020 Sep;52(09):780-5.
3. Farha J, Ramberan H, Aihara H, et al. A novel through-the-scope helix tack-and-suture device for mucosal defect closure following colorectal endoscopic submucosal dissection: a multicenter study. Endoscopy. 2023 Jun;55(06):571-7.
4. Keihanian T, Zabad N, Khalaf M, et al. Safety and efficacy of a novel suturing device for closure of large defects after endoscopic submucosal dissection (with video). Gastrointestinal Endoscopy. 2023 Sep 1;98(3):381-91.
5. Nomura T, Sugimoto S, Temma T, et al. Suturing techniques with endoscopic clips and special devices after endoscopic resection. Digestive Endoscopy. 2023 Mar;35(3):287-301.
6. Minato Y, Ohata K, Kimoto Y, et al. A modified approach for closing endoscopic submucosal dissection defects using clip with line pulley securing technique and endoloop. VideoGIE. 2024 Mar 27.
   

Introduction

Traction strategies are increasingly becoming the standard approach for endoscopic submucosal dissection (ESD). 'Natural' traction forces, such as gravity, remain valuable during ESD, helping to optimize dissection and improve procedural speed. However, mechanical traction, particularly the adaptive traction strategy, has recently shown promising results in terms of efficacy and safety, including the highest resection speeds reported in the literature for colorectal ESD (1,2).
The aim of our study was to evaluate resection speed based on initial gravitational force in a prospective cohort of patients undergoing colorectal ESD with adaptive traction strategy.

Aims & Methods

Consecutive patients undergoing ESD of conventional colorectal lesions with an adaptive traction strategy at a tertiary referral center between 2023 and 2025 were prospectively enrolled. The initial gravity was classified as favorable/neutral and unfavorable. The primary endpoint was resection speed. A non-inferiority analysis was conducted for the primary endpoint, with the non-inferiority margin set at a 20% reduction in resection speed. Secondary endpoints included the rate of En Bloc resection, the rate of R0 resection and the rate of adverse events.

Results

The study included 118 patients, of whom 78 (66%) had favorable or moderate initial lesion severity and 40 (34%) had unfavorable initial gravity. The mean resection speed in the favorable and moderate gravity group was 37.4 versus 35.8 (p = 0.6067) in the unfavorable group, the R0 resection rate was 86.2% versus 86.8% (p > 0.99), and the perforation rate was 5.9% versus 7.0% (p = 0.7015).
After adjustment for lesion location, operator and lesion area, the resection rate in the unfavorable severity group was very close to the non-inferiority margin (p = 0.07).

Conclusion

In our cohort of patients undergoing colorectal ESD using an adaptive traction strategy, initial gravity did not alter the speed and quality of resection. We can assume that the use of a mechanical adaptive traction strategy allows overcoming the need for the natural traction force provided by gravity, thus avoiding the need to mobilize patients during the procedure to achieve a more favorable gravitational force.

References

(1) Grimaldi J, Masgnaux LJ, Lafeuille P, et al. Endoscopic submucosal dissection with adaptive traction strategy: first prospective multicenter study (with video). Gastrointest Endosc. 2024 Sep;100(3):517-523.
(2) Masgnaux LJ, Grimaldi J, Rivory J, et al. Endoscopic submucosal dissection assisted by adaptive traction: results of the first 54 procedures. Endoscopy. 2024 Mar;56(3):205-211

Disclosure

Jean Grimaldi, Louis-Jean Masgnaux, Romain Legros, Jérome Rivory, Timothée Wallenhorst, Jérémie Jacques and Mathieu Pioche are co-founder of Atract Device & Co.
The other authors have no competing interests related to this study.

Introduction

Delayed perforation (DP) is a serious complication after colorectal endoscopic submucosal dissection (CESD), often requiring emergent surgery. Traditionally, DP has been managed conservatively or surgically. Recently, successful endoscopic closures have been reported. Since 2021, we have attempted endoscopic closure in patients meeting the following: (1) localized symptoms with stable condition, (2) no or minimal oral intake, and (3) endoscopic accessibility and feasibility of closure.

Aims & Methods

To compare clinical outcomes before and after the introduction of endoscopic closure for DP and to examine closure techniques. Among Among 4,848 CESD procedures (April 2008–December 2024), 16 cases (0.3%) of DP were identified. In Analysis 1, patients were divided into Group A (before closure: 2008–2020) and Group B (after closure: 2021–). In Analysis 2, closure techniques were reviewed. DP was defined as a perforation undetected during ESD but confirmed postoperatively by imaging or endoscopy.

Results

Analysis 1: Group A: 9 patients; Group B: 7. Median age: 72 vs. 70 years; male/female: 5/4 vs. 4/3. Lesion locations (cecum/ascending/transverse/sigmoid/rectum): Group A, 3/2/1/1/2; Group B, 1/3/2/1/0. Median specimen size: 48 mm vs. 46 mm.
Ulcer base closure (complete/partial/none): Group A, 2/2/5; Group B, 2/4/1. Histology (adenoma/serrated lesion/carcinoma in situ/adenocarcinoma/others): Group A, 3/4/1/1; Group B, 4/1/1/1. Median time to DP diagnosis: 63 vs. 55 hours.
Treatment in Group A was determined case-by-case; Group B applied defined criteria. Initial treatments (conservative/surgical/endoscopic): Group A, 5/4/0; Group B, 1/0/6. One case in each group initially managed conservatively required surgery later. Of 7 surgical cases, all underwent partial colectomy or drainage without stoma creation. All 6 endoscopic closure cases avoided surgery. Surgical avoidance rate: 33% vs. 86% (p=0.06).
Median time to oral intake: 8 vs. 7 days (p=0.67). Median hospitalization: 16 vs. 11 days (p<0.05).
Analysis2: All 6 closures were performed without bowel preparation. Two patients had resumed oral intake, but endoscopy was performed early.
Perforation diameter: median 10 mm (5–15). Closure methods: over-the-scope clip (OTSC; n=1), hemostatic clips (n=4), clips with polyglycolic acid (PGA) sheet (n=1).

Conclusion

Endoscopic closure for DP was associated with higher surgical avoidance and shorter hospitalization, without worsening outcomes. It may offer an effective treatment option for selected patients.​