Short-term outcome of endoscopic submucosal dissection using a clutch cutter for subepithelial lesions within the esophagogastric submucosa: a Japanese prospective observational study.

Background/Aims: The efficacy and safety of endoscopic submucosal dissection using a clutch cutter (ESD-CC) for subepithelial lesions within the esophagogastric submucosa (SELEGSM) has not been investigated. This study aimed to assess the efficacy and safety of ESD-CC for the treatment of SELEGSM. Methods: This prospective study included 15 consecutive patients with 18 SELEGSMs diagnosed by endoscopic ultrasonography. The primary outcomes were short-term outcomes including en bloc resection rate, R0 resection rate, procedure time, and complication rate. The secondary outcome was final histological diagnosis. Results: Among the participants, 18 lesions were identified: 12 in the stomach (nine patients) and six in the esophagus (six patients). The en bloc resection rate was 94.4% (17/18). The R0 resection rate was 88.9% (16/18). The median operating time was 39 min, and no instances of perforation or bleeding were observed. The final diagnoses of SELEGSM included six neuroendocrine tumors (33.3%), six granular cell tumors (33.3%), two ectopic pancreases (11.1%), one inflammatory fibroid polyp (5.6%), one leiomyoma (5.6%), one lipoma (5.6%), and one leiomyosarcoma (5.6%). Conclusions: ESD-CC appears to be a technically efficient and safe approach for SELEGSM resection, suggesting its potential as a valuable treatment option.

Efficacy of Two Kinds of Scissor-Type Knives for Colorectal Endoscopic Submucosal Dissection: A Retrospective Comparative Study.

INTRODUCTION: Scissor-type knives are spreading as safe devises in endoscopic submucosal dissection (ESD). We evaluated the efficacy of two kinds of scissor-type knives (Clutch Cutter: CC, Fujifilm Co. and SB Knife Jr2: SB, SB-KAWASUMI Laboratories. Inc.) in colorectal ESD. METHODS: This single-center retrospective study analyzed 178 ESD cases treated with CC from January 2020 to August 2021 and 91 cases with SB from September 2021 to December 2023. The two groups were compared through propensity score matching. Therapeutic results, such as ESD procedure time, en bloc resection rate, perioperative bleeding frequency, and complications, were analyzed in each group. Risk factors for long ESD procedure time (≥ 90 min) were also examined. RESULTS: After matching, 87 cases in each group were analyzed. There was no significant difference in the ESD procedure time (min, median [interquartile range]) between the CC and SB groups (54.0 [36.0-72.0] vs. 53.0 [39.0-72.0], p = 0.99). Additionally, there were no differences in the en bloc resection (100% vs. 100%, p = 1.00), perioperative perforation (1.1% vs. 1.1%, p = 1.00), or delayed bleeding (1.1% vs. 0.0%, p = 1.00). There was a significant difference in perioperative bleeding frequency (mean ± standard deviation: 1.8 ± 2.6 vs. 3.0 ± 3.5, p < 0.01). The significant risk factors (odds ratio [95% confidence interval]) for long ESD procedure time in patients treated with CC or SB were antiplatelet (7.51 [1.82-31.00]), large lesion size (1.08 [1.05-1.12]), severe fibrosis (24.30 [7.60-77.90]), and perioperative bleeding frequency (1.34 [1.14-1.56]). CONCLUSIONS: CC and SB in colorectal ESD enabled high en bloc resection and low complication rates. CC showed significantly less perioperative bleeding than SB.

The usefulness of combining the pocket-creation method with a traction device using a scissor-type knife for colorectal endoscopic submucosal dissection.

INTRODUCTION: Technical issues and long procedure time still remain a concern in colorectal endoscopic submucosal dissection (ESD). We examined the usefulness of combining the pocket-creation method (PCM) with a traction device (S-O clip; SO) using a scissor-type knife (Clutch Cutter 3.5 mm; CC) for decreasing ESD procedure time. METHODS: We retrospectively analyzed 95 ESD cases of PCM + SO + CC managed from August 2017 to April 2020 and 103 cases of PCM + CC treated from July 2016 to July 2017. We compared these two groups through propensity score matching. The main outcome was the analysis of the ESD procedure times under various conditions in each group. RESULTS: After matching, 52 cases in the PCM + SO + CC and PCM + CC groups were analyzed. The PCM + SO + CC group showed a significantly shorter ESD procedure time than the PCM + CC group (57.8 ± 31.4 vs. 81.7 ± 33.5 min, p < 0.01). Additionally, the ESD procedure time was significantly shorter in the PCM + SO + CC group than in the PCM + CC group: tumor size (tumor size < 40 mm: 45.6 ± 15.8 vs. 72.7 ± 22.9 min, p < 0.01; tumor size ≥ 40 mm: 83.1 ± 40.1 vs. 111.8 ± 45.3 min, p = 0.04), tumor location (right side: 64.7 ± 33.3 vs. 81.0 ± 29.7 min, p = 0.03; left side: 50.5 ± 28.0 vs. 82.3 ± 36.9 min, p < 0.01), tumor morphology (polypoid: 39.2 ± 18.6 vs. 74.7 ± 28.6 min, p < 0.01; nonpolypoid: 62.3 ± 32.3 vs. 84.5 ± 35.2 min, p < 0.01), endoscopist (expert: 67.3 ± 41.2 vs. 91.9 ± 40.2 min, p = 0.02; nonexpert: 50.4 ± 18.3 vs. 73.6 ± 24.9 min, p < 0.01), and fibrosis (severe fibrosis: 82.0 ± 20.5 vs. 99.8 ± 40.4 min, p = 0.169; non-severe fibrosis: 52.1 ± 23.8 vs. 75.6 ± 29.0 min, p < 0.01). CONCLUSIONS: The combination of the PCM and SO using CC achieved a reduction in the colorectal ESD procedure time.

Advances in endoscopic therapy using grasping-type scissors forceps (with video).

Endoscopic submucosal dissection (ESD) is a globally accepted minimally invasive therapy for early-stage gastrointestinal tract tumors. Although numerous electrosurgical knives have been developed for ESD, technical difficulties and high complication rates (bleeding and perforation) have limited their use worldwide. The grasping-type scissors forceps [clutch cutter (CC)] is the first forceps-type resection device developed with reference to hemostatic forceps. The aim was to allow easy and safe ESD throughout the gastrointestinal tract, as a biopsy technique, using one device. The CC can grasp the target tissue accurately and pull it away from the underlying muscle layer prior to energizing the tissue, for safe and effective incision and hemostasis during ESD. Reported clinical studies showed that ESD using the CC (ESD-CC) is a safe (perforation rate: 0%-3.6%; delayed bleeding rate: 0%-4.2%), technically efficient (en-bloc resection rate: 88.9%-100%), and single-device method for dissecting early-stage gastrointestinal tract tumors. The ESD-CC technique is simple and easy to learn because it can be completed simply by repeating the grasp, pull, and coagulate and/or incise actions using an electrosurgical current. The reported self-completion rate by non-experts was significantly better with the CC than with conventional knives (61.7% vs 24.5%, respectively; P < 0.001). Furthermore, the CC is used for other endoscopic therapies, such as endoscopic polypectomy for large pedunculated polyps, endoscopic myotomy for Zenker's diverticulum, endoscopic treatment of buried bumper syndrome, and endoscopic necrosectomy for wall-off pancreatic necrosis. The initial reports using CC for these therapies have shown favorable results. In this review, we describe the structural features of the CC, how to use the instrument, efficacies of ESD-CC, and other unique endoscopic therapies using the CC.

Assistant skill in gastric endoscopic submucosal dissection using a clutch cutter.

BACKGROUND: A clutch cutter is a scissor-type knife used in endoscopic submucosal dissection (ESD) for gastrointestinal tract tumors. The assistant during the ESD using a clutch cutter (ESD-C) needs to rotate the device and grasp the target tissue appropriately; therefore, the assistant's skill may affect the technical outcomes of ESD-C. AIM: To determine how assistant skill level affected the technical outcomes of gastric ESD-C using an ex vivo porcine training model. METHODS: In this pilot study, mock lesions of 15-30 mm in diameter were created in the middle or lower third of the porcine stomach. A total of 32 ESD-C procedures were performed by 16 trainees. Each trainee operator performed two ESD-C procedures; one ESD-C was assisted by an expert (ESD-C-E), and the other was assisted by a non-expert (ESD-C-NE). The total procedure time of the ESD was set as the primary outcome, and en bloc resection rate, complete procedure rate, perforation rate, and each procedure time/speed for mucosal incision or submucosal dissection were set as the secondary outcomes. In addition, we investigated factors associated with the difficulty of ESD including incompletion of ESD procedure, a long procedure time (≥ 20 min) or intraoperative perforation. RESULTS: The median total procedure time of the ESD-C-E was significantly shorter than that of the ESD-C-NE (12.9 min vs 21.9 min, P = 0.001). The en bloc resection rate was 100% in both groups. Complete resection rates of the ESD-C-E and ESD-C-NE groups were 100% and 93.8%, respectively. No intraoperative perforation was observed in both groups. In the multivariate analysis, assistant skill was significantly associated with the difficulty of ESD, with the highest odds ratio of 16.5. CONCLUSION: Assistance by an expert is an important factor when trainees perform ESD-C procedures.

Current Challenge: Endoscopic Submucosal Dissection of Superficial Non-ampullary Duodenal Epithelial Tumors.

OPINION STATEMENT: With the widespread use of esophagogastroduodenoscopy in recent years, the detection rate of superficial non-ampullary duodenal epithelial tumors (SNADETs) is increasing. Most SNADETs are early-stage adenocarcinoma or benign conditions, including adenoma. Therefore, endoscopic resection is desirable from the perspective of quality of life. However, endoscopic resection for SNADETs has not yet been established. Endoscopic submucosal dissection (ESD) is the most promising method for the treatment of SNADETs, because ESD provides a high rate of en bloc resection and a low rate of recurrence regardless of the tumor size. However, the difficulty of the procedure and a high rate of severe adverse events including perforation and bleeding have become major problems. Various preventive countermeasures for adverse events, such as use of specific devices, endoscope stabilization methods, and endoscopic closure of the post-ESD ulcer using clips, are reported to reduce the risk of the adverse events of ESD for SNADETs. This article reviews and highlights the current state of ESD for SNADETs and new challenges towards safe and effective ESD.

Endoscopic submucosal dissection with a grasping-type scissors for early colorectal epithelial neoplasms: a large single-center experience.

BACKGROUND AND AIMS: The Clutch Cutter (CC) can grasp, pull, coagulate, and incise targeted tissue with the use of electrosurgical current. It was developed as a biopsy technique to reduce the technical difficulty of endoscopic submucosal dissection (ESD) with knives. The aim of this study was to evaluate the efficacy and safety of ESD using the CC (ESD-CC) for early colorectal epithelial neoplasms (ECENs). METHODS: In this prospective study, we enrolled 437 consecutive patients with a diagnosis of ECEN between January 2009 and January 2018. They all satisfied the Japanese colorectal cancer treatment guidelines for ESD; namely, confirmation by preliminary endoscopy, EUS, and endoscopic biopsy. The CC was used for all steps of ESD (mucosal incision, submucosal dissection, and hemostatic treatment); therapeutic efficacy and safety were assessed. RESULTS: The en bloc resection rate was 99.3% (434/437), and the R0 resection rate was 87.0% (380/437). The mean operating time was 88.3 minutes. Perforation occurred in 10 cases (2.3%) and was managed with conservative medical treatment. Post-ESD-CC bleeding occurred in 10 cases (2.3%) and was successfully treated by endoscopic hemostatic treatment. CONCLUSIONS: ESD-CC is a technically efficient, safe, and easy method for resecting ECEN.

Clutch Cutter knife efficacy in endoscopic submucosal dissection for early gastric neoplasms.

AIM: To compare the outcomes of endoscopic submucosal dissection (ESD) for gastric neoplasms using Clutch Cutter (ESD-C) or other knives (ESD-O). METHODS: This was a single-center retrospective study. Gastric neoplasms treated by ESD between April 2016 and October 2017 at Kitakyushu Municipal Medical Center were reviewed. Multivariate analyses and propensity score matching were used to reduce biases. Covariates included factors that might affect outcomes of ESD, including age, sex, underlying disease, anti-thrombotic drugs use, tumor location, tumor position, tumor size, tumor depth, tumor morphology, tumor histology, ulcer (scar), and operator skill. The treatment outcomes were compared among two groups. The primary outcome was ESD procedure time. Secondary outcomes were en bloc, complete, and curative resection rates, and adverse events rates including perforation and delayed bleeding. RESULTS: A total of 155 patients were included in this study; 44 pairs were created by propensity score matching. Background characteristics were quite similar among two groups after matching. Procedure time was significantly shorter for ESD-C (median; 49 min) than for ESD-O (median; 88.5 min) (P < 0.01). However, there was no significant difference in treatment outcomes between ESD-C and ESD-O including en bloc resection rate (100% in both groups), complete resection rate (100% in both groups), curative resection rate (86.4% vs 88.6%, P = 0.730), delayed bleeding (2.3% vs 6.8%, P = 0.62) and perforation (0% in both groups). CONCLUSION: ESD-C achieved shorter procedure time without an increase in complication risk. Therefore, ESD-C could become an effective ESD option for gastric neoplasms.

Clinical outcomes of Clutch Cutter endoscopic submucosal dissection for older patients with early gastric cancer.

AIM: To evaluate the clinical outcome of endoscopic submucosal dissection using the Clutch Cutter (ESDCC) in older patients. METHODS: We reviewed 232 consecutive patients with early gastric cancer who underwent ESDCC between June 2010 and February 2014 at Aso Iizuka Hospital. We divided patients into two groups according to age: Older patients (> 80 years, n = 64) and non-older patients (≤ 80 years, n = 168). We retrospectively compared the prevalence rates of pre-existing comorbidities, anticoagulant therapy, en bloc resection, mean duration of hospitalization, incidence of ESDCC-related complications, change in performance status (PS) before and after ESDCC, and financial cost of admission. RESULTS: The older group comprised 64 patients with a mean age of 84.1 years, and the non-older group comprised 168 patients with a mean age of 69.5 years. Older patients had significantly more pre-existing comorbidities than did non-older patients, specifically heart disease (P < 0.05). The en bloc resection rate in non-older patients was significantly higher than that in older patients (100% vs 95.3%, P = 0.02). There were no significant differences between the older and non-older groups in the incidence of ESDCC-related complications (i.e., postoperative bleeding and perforation) and the post-ESDCC change in PS. There were also no significant differences between the older and non-older groups in the mean duration of hospitalization (11.4 and 10.7 d, respectively) and financial cost of admission (657040 JPY and 574890 JPY, respectively). CONCLUSION: ESDCC has a good clinical outcome in older patients.

Endoscopic submucosal dissection of gastric adenomas using the clutch cutter.

AIM: To evaluate the efficacy and safety of endoscopic submucosal dissection (ESD) using the clutch cutter (CC) (ESD-CC) for gastric adenoma (GA). METHODS: From June 2007 to August 2015, 122 consecutive patients with histological diagnoses of GA from specimens resected by ESD-CC were enrolled in this prospective study. The CC was used for all ESD steps (marking, mucosal incision, submucosal dissection, and hemostatic treatment), and its therapeutic efficacy and safety were assessed. RESULTS: Both the en-bloc resection rate and the R0 resection rate were 100% (122/122). The mean surgical time was 77.4 min, but the time varied significantly according to tumor size and location. No patients suffered perforation. Post-ESD-CC bleeding occurred in six cases (4.9%) that were successfully resolved by endoscopic hemostatic treatment. CONCLUSION: ESD-CC is a technically efficient, safe, and easy method for resecting GA.

Endoscopic submucosal dissection for rectal carcinoid tumour using the Clutch Cutter.

BACKGROUND: To reduce the risk of complications related to endoscopic submucosal dissection (ESD) using knives, we developed the Clutch Cutter (CC), which can grasp and incise the target tissue similarly to biopsy techniques using an electrosurgical current. The aim of this study was to evaluate the efficacy and safety of ESD using the CC for removal of rectal carcinoid tumours. METHODS: Between December 2009 and December 2011, we prospectively enrolled seven patients (seven lesions) on 7 different days. Patients were endoscopically diagnosed with rectal subepithelial lesions (upper rectum, n = 3; lower rectum, n = 4) within the level 3 layer and without lymph node involvement, with the diagnosis confirmed by preliminary endoscopy, endoscopic ultrasound and endoscopic biopsies. ESD using the CC was performed in all cases, and the therapeutic efficacy, safety and tumour recurrence were assessed. RESULTS: All lesions were treated easily and safely, and there were no inadvertent incisions. En bloc resection was obtained in all cases, and histologic tumour-free lateral/basal margins were obtained in six of the seven patients. No delayed haemorrhage, perforation or tumour recurrence occurred. CONCLUSION: ESD using the CC appears to be an easy, safe and technically efficient method for resecting rectal carcinoid tumour.

Endoscopic submucosal dissection for esophageal granular cell tumor using the clutch cutter.

Endoscopic submucosal dissection (ESD) with a knife is a technically demanding procedure associated with a high complication rate. The shortcomings of this method are the deficiencies of fixing the knife to the target lesion, and of compressing it. These shortcomings can lead to major complications such as perforation and bleeding. To reduce the risk of complications related to ESD, we developed a new grasping type scissors forceps (Clutch Cutter®, Fujifilm, Japan) which can grasp and incise the targeted tissue using an electrosurgical current. Esophagogastroduodenoscopy on a 59-year-old Japanese man revealed a 16mm esophageal submucosal nodule with central depression. Endoscopic ultrasonography demonstrated a hypoechoic solid tumor limited to the submucosa without lymph node involvement. The histologic diagnosis of the specimen obtained by biopsy was granular cell tumor. It was safely and accurately resected without unexpected incision by ESD using the CC. No delayed hemorrhage or perforation occurred. Histological examination confirmed that the granular cell tumor was completely excised with negative resection margin.We report herein a case of esophageal granular cell tumor successfully treated by an ESD technique using the CC.