Introduction

The ‘Speedboat-RS2/SRS2’ (Creo-Medical/Wales/UK) is the first multi-modality device, incorporating bipolar-radiofrequency/BRF energy cutting, microwave energy coagulation/MWC, an integrated needle for submucosal injection and a rotatable blade with a heat insulated hull for protection.

Aims & Methods

A prospective cohort of colorectal Speedboat-assisted Submucosal Dissection (SSD) was initiated for a duration of three operational years. One experienced operator performed all cases. Short and long-term clinical outcomes were recorded. Linear regression was used to explore whether factors, such as polyp size/surface/location/morphology could implicate with the duration of the procedure in minutes.

Results

184 patients were subject to SSD using tunnelling technique. 19 abandoned (14 for muscle retraction sign, 7 advanced cancer), 5 for medical emergencies. Out of 165, endoscopically complete en-bloc resection was achieved in 91.5% (n=151), curative rate 82% (n=18). Conversion to piecemeal resection 8.5% (n=14)due to inappropriate booking and scope difficulties.Within the en-bloc group, mean polyp 5.45cm +/- 2.81 SD, mean polyp surface 22.63cm2 +/- 25.03 SD.Overall mean procedural time in minutes was 105.98 +/- 82.78 SD. Non-rectal polyps 75/151 (49.7%), non-granular polyps 51/151 (34%), high dysplastic polyps 36/151 (25.2%), cancers 20/151 (14%). Six out of 20completely excised (R0) T1 cancers had no recurrence in endoscopy (4/6) or surgery (2/6). Fourteen out of 20T1 cancers with adverse histology features had no residual malignancy in the surgical specimen with 2/4showed LN metastases requiring chemotherapy. A case of advanced NET within a benign adenoma requiredchemotherapy. Three out of 14 opted for surveillance only with no recurrence on endoscopy in two of them.First surveillance endoscopy available for 71/151 (47%) with no recurrence identified.MWC used to pre-coagulate and control bleeding in all cases. Hemostatic monopolar forceps was required in11/151 cases. Endoscopically controlled delayed bleeding occurred in 3 patients (2%). No perforation wasrecorded.Regression analysis revealed significant effect of cm2 size and fibrosis on the duration of the procedure (p <.001, R2 = .778), indicating an increase of 2.271t minutes per 1cm2 of increase in polyp surface and anincrease of 37.34 minutes when severe fibrosis is encountered; with a baseline time of 23 mins reflecting polypof 10cm2.

Conclusion

These first results demonstrate that Speedboat is an effective and safe device for submucosal colorectal dissections. SRS2 performed in a timely manner, and the preliminary correlation of the time of the procedure affected by polyp surface and degree of fibrosis warrants further analysis.

Introduction

Speedboat™ is a novel multimodal endosurgical device. It utilizes the use of advanced bipolar energy for cutting/dissection and super-high frequency microwave energy for coagulation. AirSeal® is a trans-anal access port that creates an “invisible pneumo- dissection” effect by instantaneously responding to changes in intraluminal pressure, with CO2 exchange.

Aims & Methods

This study aims to evaluate the efficacy of Speedboat assisted Endoscopic Submucosal Dissection (S-ESD) with and without AirSeal in the management of complex distal colorectal polyps as well as the speed of dissection.
Data, from a prospectively collected clinical audit and later a dedicated S-ESD registry (2018-2025) was analyzed. Cases were divided into three groups, the pre-AirSeal group (2018-2020), AirSeal group (2021-2025) and non-AirSeal (2021-2025). Lesions characteristics, long and short axis length, time of dissection and clinical outcomes were collected. Lesion surface (cm²) and Speed (cm2/hr) were calculated. Clinical outcomes and dissection speed were compared between the three groups.

Results

Over the study period, a total of 253 consecutive patients [56.1% male, age 72 (IQR: 65-77)] had a distal colorectal lesion completely excised using S-ESD with median surface of 12.95cm² (IQR:6.87-21.68), long axis 5,0 cm (IQR: 3.5-7.0) and speed 9.42cm2/hr (IQR:6.97-15.75).
Pre-AirSeal group included 58 patients [58.6% male, age 72 (IQR 65-77)] with median surface of 9.81cm² (IQR:6.72-15.89), long axis 4.5cm (IQR: 3.5-6.1) and speed 7.15 (IQR: 6.86-9.31). Since AirSeal introduction in 2020 195 patients with distal polyps had S-ESD [55.4%male, age 72 (IQR: 64-76)] with median surface of 14.19 cm² (IQR:6.91-27.47), long axis 5.0cm (IQR: 3.5-7.0) and speed 11.41 (IQR: 6.17-18.00)].
In the AirSeal group 127 patients underwent S-ESD [58.3% male, age 71(IQR: 63-76), median surface 15.70 (IQR: 8.24-30.90) and speed 11.41 (IQR: 7.06-16.63). In the non-AirSeal group 68 patients were subject to S-ESD [50% male, age 72 (IQR: 66-78), median surface 11.38 (IQR: 5.15-19.28)].
There was not a significant difference in dissection speed between AirSeal and non-AirSeal group (p=0.158) but the median surface of the polyps removed were significantly larger in the AirSeal group (p=0.005). Overall, the speed and surface were significantly increased in the period when AirSeal was used when compared with the pre-Airseal group (p<0.001 and p=0.012 respectively). No statistically significant difference in regards with age and gender was found among any of the groups.

Conclusion

The use of AirSeal combined with S-ESD appears to facilitate excision of distal lesions with larger surface with reasonable speed over time. A randomized trial to investigate the role of pneumo-dissection is warranted.

Introduction

Endoscopic submucosal dissection (ESD) is emerging as the standard treatment for suspected superficial submucosal invasion lesions. Considering the global population ageing, understating the feasibility of this approach in elderly patients is of the utmost importance. Studies in this field have shown a tendency towards reduced resection rates and higher rates of complications.

Aims & Methods

We sought to assess the effectiveness and safety of colorectal ESD for patients aged ≥ 80 yo compared to 65-79 yo patients. We prospectively enrolled consecutive patients aged >64 years undergoing colorectal ESD between January 2019 and December 2023 from ten Italian Tertiary Referral Centres. Patients were classified as Elderly Group (E-Group, age >80 yo) and non-elderly group (NE-Group, 65-79 yo). Procedure outcomes and adverse events were compared between E-Group and NE-Group and between patients with comorbidities and healthy (1-CM-Group and H-Group).

Results

A total of 980 patients were included [269 (27.5%) in the E-Group and 711 (72.5%) in the NE-Group]. Table 1 summarises the principal data and outcomes.

En-bloc resection and R0 rate did not statistically differ (p=0.30; p=0.05) between E and NE-Groups. Oncological curative resection was achieved in the two groups without significant differences (p=0.41). Histological outcomes were comparable between the two groups, except for lymphovascular invasion [E:14 (5.2%) vs NE:14 (2.0%); p=0.007 – OR:2.9 (CI:1.3-6-6)]. Regarding clinical course, intraprocedural and 14 days-adverse events (AEs), no statistically significant differences were found between the two groups, except for a higher rate of post-procedure delirium in the E-Group [6 (2.2%) vs 1 (0.1%); p=0.001–OR:16.2 (CI:1.9-135.2)]. 1-CM-Group showed a higher rate of intraprocedural bleeding (p=0.001), fever onset (p<0.001), C-reactive protein (p=0.006) and procalcitonin increase (p=0.02), delayed perforation (p=0.03) and systemic infections (p=0.02) compared to the H-Group. The presence of one or more comorbidity, but not the age, was associated with a poorer clinical course [p<0.001; OR:2.3 (CI:1.5-3.6)] and poor overall course (poor clinical course combined with 14 days AEs) [p=<0.001; OR:2.1 (CI:1.4-3.0)]. ASA classification (OR: 1.36; CI:1.01-1.83), the presence of one comorbidity (OR: 1.73; CI:1.14-2.63), and procedure time (OR: 1.01; CI:1.00-1.01) were poor outcome predictors. After excluding patients with at least one comorbidity, still no differences in terms of poor overall course (p=0.21) were registered between E and NE-Group.

Conclusion

Colorectal ESD is an effective and safe procedure in elderly patients. Physicians should ackowledge delirium as a possible AE in patients aged over 80. The presence of comorbidities should drive the execution of a comprehensive pre-procedural assessment and post-procedural care, to optimize outcomes and minimize complications.

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

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

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.