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

Although endoscopic submucosal dissection (ESD) can be useful for treating early colorectal neoplasms, colorectal ESD is technically more difficult, with certain organ characteristics rendering the procedure even more challenging and increasing the risk of perforation. Herein, we used scissor-type knives (SB Knife Jr and Jr2, Sumitomo Bakelite, Japan) that enabled the maintenance of an adequate dissection layer and prevented unexpected muscular layer injuries. However, scissor-type knives demonstrated slower resection compared with needle-type knives. This drawback was overcome by using a traction device on the lesion, which facilitated accurate visualization and easier dissection as well as increased the resection speed during colorectal ESD using a needle-type knife. Nevertheless, reports regarding the effectiveness of a traction device when using a scissor-type knife for colorectal ESD remain scarce.

Aims & Methods

This study aimed to evaluate the efficacy and safety of ESD performed using a scissor-type knife with and without a traction device for treating early colorectal neoplasms. Between October 2010 and January 2023, ESD was performed for 619 lesions in 582 patients (male-to-female ratio, 332:250; mean age, 70.0 years) in the Kure medical center. ESD was performed without a traction device for 531 lesions (Group A) and with a traction device for 88 lesions (Group B). We compared the en-bloc resection rate, complete resection rate, tumor size, procedure time, resection speed, and adverse events of the groups.

Results

Five and two interruptions occurred in Groups A and B, respectively. The en-bloc resection rate was 99.0% (521/526) in Group A and 97.7% (84/86) in Group B (p = 0.26). The complete resection rate was 97.0% (510/526) and 95.3% (82/86) in Groups A and B, respectively (p = 0.51). The mean tumor diameter was 33.4 ± 16.9 and 37.2 ± 20.9 mm in Groups A and B, respectively (p = 0.11). The mean procedure time was 86.4 ± 67.6 and 73.2 ± 66.0 min in Groups A and B, respectively (p = 0.09). The mean resection speed (the resected specimen area [mm²] divided by the procedure time [min]) was 13.2 ± 10.4 and 22.9 ± 11.9 mm²/min in Groups A and B, respectively, with the speed in Group B significantly faster than that in Group A (p < 0.01). There was one case each of intraoperative perforation and delayed perforation in Group A (1/526, 0.2% each), while there were none in Group B (0/86, 0%). Both cases of perforation were treated conservatively. There were 10 cases of delayed hemorrhage in Group A (10/526, 1.9%), and none in Group B (0/86, 0%; p = 0.37). The hemorrhage was controlled with endoscopic hemostasis in all cases.

Conclusion

ESD using a scissor-type knife either with or without a traction device is technically efficient and safe. Moreover, its drawback of slow resection speed may be overcome by the use of a traction device.

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

A positive resection margin after endoscopic submucosal dissection (ESD) of a colorectal neoplasm is associated with an increased risk of recurrence. However, it may be caused by cauterization or tangential specimen cutting. We aimed to identify the clinical significance of positive resection margins in colorectal neoplasms after ESD.

Aims & Methods

We reviewed 1010 patients who underwent colorectal ESD at two hospitals between 2015 and 2020. The inclusion criteria were that the patient 1) had an en bloc resection, 2) had at least one follow-up colonoscopy. The recurrence rates and presence of residual tumors in the surgical specimens were evaluated.

Results

A total of 632 patients were enrolled. Among them, 557 patients had complete resections, and 75 had incomplete resections with positive resection margins in vertical and/or horizontal margin. The rate of additional surgery after ESD and recurrence was significantly higher in patients with incomplete resection compared to patients with complete resection. However, in patients with non-invasive colorectal neoplasm, all 411 patients, including those with complete and incomplete resection, had no recurrence. Among 221 patients with invasive lesions, 39 underwent additional surgery due to non-curative resection. Positive vertical margin and lymphovascular invasion were associated with remnant tumors in the surgical specimen. Lymphovascular invasion was associated with lymph node metastasis. However, no remnant tumor nor lymph node metastases were found in patients with only one unfavorable histological factor, including 1) positive vertical margin, 2) a submucosal invasion depth > 1000 µm, 3) lymphovascular invasion, 4) poorly differentiated cancer, and 5) high tumor-budding grade.

Conclusion

A positive resection margin after en bloc colorectal ESD for noninvasive lesions was not associated with recurrence. In T1 colorectal cancer with a positive vertical resection margin, salvage surgery can be considered in selected patients with additional risk factors.

Introduction

During endoscopic submucosal dissection (ESD) of colorectal neoplasms, an interesting feature is occasionally detected in which the muscle layer under the tumour seems to be pulled upwards into the lesion in a triangle-shape. This feature is named muscle retracting sign (MR sign) and appears to indicate a potentially difficult ESD with high risk of incomplete and non-curative resection, although data about this subject is still scarce, without current studies in western countries. The aim of this study was to evaluate whether or not MR sign is associated with worst outcomes.

Aims & Methods

A retrospective analysis, using a prospectively collected database from 2 western centres, including all patients who underwent ESD for colorectal neoplasms with positivity for MR sign from July 2017 to January 2023 was performed. The presence of MR sign was determined by the endoscopist during the procedure. The results were evaluated in terms of complete, en bloc, R0 and curative resection rates, complications and local recurrence.

Results

In a total of 411 lesions treated by ESD, 26 presented MR sign (6.3%, mean size 62,3mm, range 20-180mm): 9 colonic and 17 rectal, corresponding to 26 patients (male 61.5%, mean age 70 years): 9 in colon and 17 in rectum. Morphologically and according to Paris classification, 13 were 0-Is (50%), 10 LST-G-M (38.5%), 1 0-Isp, 1 LST-G-N and 1 LST-NG-F. Technical success was achieved in 24 lesions (24/26, 92.3%) with 2 procedures aborted due to the perception of high perforation risk, both located in the colon (2/9, 22%). In the rectum, there was the need to perform intramuscular dissection in 3 procedures to complete the resection (3/17, 17.6%). Among resected lesions, en bloc and R0 resection rates were 100% and 66.7% (16/24). According to ESGE 2022 criteria, resection was considered curative in 66.7% (16/24), non-curative with high risk in 8.3% (2/24) and with local-risk recurrence in 25% (6/24). Intraprocedure complications were recorded in 2 resections (8%), both in the rectum and both perforations endoscopically managed. No recurrence was recorded in a mean follow-up time of 7 months (range 1-22 months).

Conclusion

This analysis show that MR sign is mostly present in large bulky protruding lesions and seems associated with a higher incomplete resection procedure rate in colon lesions but in rectum. Also, it seems associated with higher complication rate, namely perforations, and non-curative resection rates among resected lesions. Therefore, in the colon, an anticipated switch for surgery in clinically fit patients should be considered in the presence of this sign or even before initiating ESD when lesion morphology suggests its presence. To the authors’ best knowledge, this is the first study of the impact of the present of MRS in ESD in the West.

References

Toyonaga T, Tanaka S, Man-I M, East J, Ono W, Nishino E, et al. Clinical significance of the muscle-retracting sign during colorectal endoscopic submucosal dissection. Endosc Int Open. 2015;3(03):E246–51.
Suzuki N, Dhillon A, Seward E, Humphries A. CLIP MUSCLE PROTECTION (CLIMP) METHOD IN MUSCLE-RETRACTING SIGN DURING COLONIC ENDOSCOPIC SUBMUCOSAL DISSECTION. Gut. 2021;70(Suppl 1):A1–A262.

Disclosure

Toyonaga T, Tanaka S, Man-I M, East J, Ono W, Nishino E, et al. Clinical significance of the muscle-retracting sign during colorectal endoscopic submucosal dissection. Endosc Int Open. 2015;3(03):E246–51.

Introduction

Endoscopic submucosal dissection (ESD) is an advanced technique that can provide a successful ‘en-bloc’ and R0 resection rate for large gastrointestinal (GI) lesions. To date, several ESD techniques have been proposed, but their comparative efficacy is still unclear.

Aims & Methods

This network meta-analysis aims to investigate and compare the efficacy and safety of different ESD techniques for resection of colonic lesions. MEDLINE, Embase, Scopus, and the Cochrane Library were systematically searched for randomized controlled trials (RCTs) comparing different ESD techniques through March 2024. The primary outcomes were ‘en-bloc’ and R0 resection rates. The secondary outcome was the incidence of procedure-related AEs. Direct and indirect comparisons were performed among different ESD techniques. Results were expressed as risk ratio (RR) and 95% confidence interval (CI), using the DerSimonian and Laird random-effects model. The relative ranking of the interventions for achieving the aforementioned outcomes was calculated as their surface under the cumulative ranking curve (SUCRA). The study quality was evaluated using the revised Cochrane risk-of-bias (RoB2) tool for randomized trials.

Results

After selection of studies, 9 RCTs were included in the systematic review.
On network meta-analysis for ‘en-bloc’ resection (9 RCTs, 872 patients, 5 techniques assessed), pocked with traction ESD (PT-ESD) (RR=1.02 - 95%CI=0.96-1.07) and pocket ESD (P-ESD) (RR=1.02 - 95%CI=0.98-1.05) showed higher efficacy, whereas hybrid ESD (H-ESD) (RR=0.94 - 95%CI=0.87-1.02) lower efficacy compared to conventional ESD (C-ESD).
On network meta-analysis for R0 resection (7 RCTs, 732 patients, 4 techniques assessed), PT-ESD (RR=1.05 - 95%CI=0.96-1.16) showed higher efficacy, and H-ESD (RR=0.97 - 95%CI=0.84-1.13) lower efficacy compared to C-ESD. Overall, P-ESD resulted the best technique for ‘en-bloc’ resection (SUCRA 0.70) and PT-ESD for R0 (SUCRA 0.83), while H-ESD showed the poorest performance for both outcomes (SUCRA 0.06 and 0.30, respectively) (Table 1).
On network meta-analysis for AEs (9 RCTs, 872 patients, 5 techniques assessed), PT-ESD (RR=0.35 - 95%CI=0.05-2.48) was associated with a lower incidence of AEs, and H-ESD (RR=1.22 - 95%CI=0.30-5.01) with higher incidence of AEs, compared to C-ESD. Overall, PT-ESD resulted as the safest technique (SUCRA 0.83), followed by T-ESD (SUCRA 0.60), whereas H-ESD showed the poorest performance (SUCRA 0.28).
According to the RoB2 tool, none of the studies included was of poor methodological quality except for one.


Table 1. SUCRA score ranking of different interventions in terms of ‘en-bloc’ resection rate, R0 resection rate and incidence of AEs.

Conclusion

The results of this network meta-analysis show a trend towards greater effectiveness and safety of PT-ESD for the removal of colonic lesions. H-ESD was associated with worse results and should be avoided, preferring other techniques.