Self-Completion Method of Endoscopic Submucosal Dissection Using Endosaber without Any Other Device or Assistance: An ex vivo Porcine Model Study.

BACKGROUND: Endoscopic submucosal dissection (ESD) is a standard treatment for tumors of the gastrointestinal tract. We developed a self-completion method of ESD using Endosaber to eliminate the need for an additional device or human assistance during the procedure. The aim of this study was to evaluate the technical feasibility and outcomes of this method in an ex vivo porcine training model. METHODS: This was a pilot study, and the procedures were performed by 4 experts. Mock lesions measuring 15 mm in diameter were prepared at the posterior wall in the middle or lower esophagus obtained from domestic pigs. Each operator performed ESD on the mock lesions in 3 models. The primary outcome was ESD completion rate using the self-completion method. The secondary outcomes were procedure time, en bloc resection rate, perforation rate, and number of injections during the procedure. RESULTS: All 12 ESDs were completed using the self-completion method. The median procedure time (interquartile range) was 483.5 (399-619.3) s (median incision time: 240.4 [168.3-332.5] s; median dissection time: 222 [182.8-257] s). En bloc resection rate was 100%. No perforation was noted during any of the procedures. The median number of injections was 10.5 (9-14.3). The procedure time decreased significantly with increase in experience (p = 0.020). CONCLUSIONS: The self-completion ESD method using one Endosaber without any assistance achieved a 100% en bloc resection rate without any perforation. The need for an additional device or assistance was successfully eliminated. This method may prove to be a simple and cost-effective ESD procedure for lesions in humans.

Transrectal laparoscopy using flexible endoscopy with a submucosal tunneling method: Porcine survival model.

OBJECTIVES: Transrectal laparoscopy (TRLS) using a flexible endoscope was recently proposed for peritoneal observation. Although previous studies have reported its feasibility, follow-up durations were insufficient to ascertain technical safety. Moreover, knowledge about the technical feasibility of collecting peritoneal cytological lavage or ascites during TRLS is limited. Thus, this study aimed to confirm the safety and efficacy of TRLS in a porcine survival model. METHODS: After creating artificial ascites in 10 animals, TRLS was performed as follows: submucosal tunnel creation on the anterior wall of the rectum, intentional perforation at the distal end of the tunnel, endoscopic ascites collection and intraperitoneal observation, and clip closure at the mucosal incision site. The pigs were administered antibiotics orally for 7 days after TRLS and killed for histological evaluation and bacterial culture after 28 days of observation. RESULTS: The technical success rates of insertion into the abdominal cavity, ascites collection, and clip closure were 100%. All frequent anatomical sites for peritoneal dissemination including the stomach, subdiaphragmatic space, and pelvic space were fully observable without adverse events. The median procedure time was 36.3 min. Full 28-day survival was observed in all cases without any infection. The autopsies showed no infection, including abscess formation. Bacterial cultures of the peritoneal cavity were negative 28 days after TRLS in all cases. CONCLUSIONS: Transrectal laparoscopy enabled ascites collection and intraperitoneal observation without adverse events. All animals survived without peritonitis. Therefore, TRLS can be an option for intraperitoneal examination.

The effect of scissor-type versus non-scissor-type knives on the technical outcomes in endoscopic submucosal dissection for superficial esophageal cancer: a multi-center retrospective study.

The Clutch Cutter was invented as a scissor-type knife for endoscopic submucosal dissection (ESD) of gastrointestinal neoplasms. ESD with the scissor-type knife (ESD-S) may be considered a technically easier procedure than ESD with non-scissor-type knives (ESD-NS). Therefore, this study aimed to compare the technical outcomes of ESD-S with those of ESD-NS for superficial esophageal cancer. This was a multicenter retrospective study. Patients with superficial esophageal cancer treated with ESD between October 2015 and March 2018 at three hospitals were retrospectively reviewed. The ESD-S group had 48 patients and the ESD-NS group had 114 patients. A propensity score matching analysis was performed to compensate for the confounding bias between both groups. Multivariate analyses and propensity score matching were used to adjust for age, sex, the tumor size, tumor location, tumor depth, degree of tumor circumference, operator level, usage of the traction method, and the sedation method. The primary outcome was the procedure time of the ESD. Secondary outcomes were the rate of en-bloc/complete resection and the rate of complications including perforation, delayed bleeding, and stricture. Propensity score matching analysis provided 36 matched pairs. Median procedure time in the ESD-S group was significantly shorter than that in the ESD-NS group (44.0 min vs. 66.5 min, P = 0.020). In addition, the treatment outcomes were similar in both groups (en-bloc resection: 100% vs. 97.2%, P = 1; complete resection: 88.9% vs. 86.1%, P = 1; curative resection: 80.6% vs. 77.8%, P = 1; perforation: 0% vs. 5.6%, P = 0.49; delayed bleeding: 0% in both groups; stricture: 2.8% vs. 8.3%, P = 0.61). ESD-S was associated with a shorter procedure time than ESD-NS, without an increase in the incidence of complications. Therefore, the scissor-type knife should be considered as an endo-knife for ESD of superficial esophageal cancers.

Ex vivo porcine model study on the treatment outcomes of scissor-type knife versus needle-type knife in endoscopic submucosal dissection performed by trainees.

BACKGROUND: Endoscopic submucosal dissection (ESD) for gastrointestinal neoplasms can be technically difficult for trainee endoscopists. Presently, there is no consensus for trainees to select the endo-knife type in ESD. Therefore, we conducted a comparison study of treatment outcomes between scissors-type and needle-type knives in ESD performed by trainees in an ex vivo porcine model. METHODS: This study was conducted on trainee endoscopists who participated in ESD hands-on seminars held in August 2018 and September 2019. A total of 22 trainees from 13 institutions were divided into two groups according to their endoscopic experience. Under expert supervision, each trainee performed two ESDs in porcine models, namely, scissor-type knife (ESD-S) and needle-type knife (ESD-N). The efficacy and safety, including the procedure time and rates of self-completion, en bloc resection, and complications, were compared between ESD-S and ESD-N. In subgroup analysis, we also investigated the predictors associated with the difficulty of ESD for trainees using multivariate logistic regression analysis. RESULTS: Eight trainees had an experience of over 1000 endoscopies (senior trainee: S-Trainee), whereas the others had an experience of less than 1000 endoscopies (junior trainee: J-Trainee). Among the S-Trainees, no significant differences were observed in any treatment outcome between ESD-S and ESD-N. Among the J-Trainees, the total procedure and mucosal incision times were significantly shorter in ESD-S than in ESD-N [total procedure time: 16.5 min (range 10.0-31.0) vs. 22.3 min (range 10.0-38.0), P = 0.018; circumferential incision time: 10.0 min (range 6-16) vs. 17.0 min (range 5.0-31.5); P = 0.019]. Regarding complications, muscular injury occurred in two patients during ESD-N performed by J-Trainees; however, no muscular injury occurred during ESD-S. In subgroup analysis, ESD-N was an independent predictive factor of difficult ESD (odds ratio 5.28, 95% confidence interval 1.25-22.30; P = 0.024). CONCLUSIONS: This study revealed that trainees, particularly those who have experienced less than 1000 endoscopies, should opt for the scissor-type knife to perform ESD.

Self-completion method of endoscopic submucosal dissection using the Endosaber for treating colorectal neoplasms (with video).

Endoscopic submucosal dissection (ESD) is effective for the treatment of colorectal neoplasms. We have developed a self-completion ESD (S-ESD) using Endosaber without requiring additional instruments or assistance. This prospective cohort study was conducted to investigate the feasibility of S-ESD for colorectal neoplasms. Patients with colorectal neoplasms measuring 20-40 mm in size were enrolled. A single operator, without assistance, performed ESD using only the Endosaber. The primary outcome was the success rate of S-ESD. Secondary outcomes included procedure time, the rates of en bloc, complete, and curative resection, and complication rates, including the incidence of perforation and delayed bleeding. In total, 15 patients with 15 lesions were enrolled. The median size of the resected lesions was 28 mm (interquartile range 25-29 mm). S-ESD success rate of 100% was achieved. The median procedure time was 44 min (29.5-53.5 min). We observed en bloc, complete, and curative resection rates of 100%, 93.3%, and 86.7%, respectively, and a complication rate of 6.7% (perforation: 0%, delayed bleeding: 6.7%). S-ESD for colorectal neoplasms was successfully performed with favorable treatment outcomes and low complication rates. S-ESD reduces the number of devices and extent of assistance, making S-ESD a simple and cost-effective procedure.

Reduction in the procedure time of hybrid endoscopic submucosal dissection for early gastric neoplasms: a multi-center retrospective propensity score-matched analysis.

BACKGROUND: Endoscopic submucosal dissection (ESD) for early gastric neoplasms is still a technically difficult and time-consuming procedure. Hybrid ESD (H-ESD) involves circumferential incision with partial submucosal dissection combined with subsequent mucosal resection by snaring, wherein the newly developed device allows us to perform H-ESD using a single device. This study aimed to determine the clinical outcomes of H-ESD compared with conventional ESD (C-ESD) for early gastric neoplasms. METHODS: In this multi-center, retrospective study, using propensity score-matched analysis, we reviewed the charts of patients with early gastric neoplasms smaller than 20 mm treated with H-ESD or C-ESD at three hospitals between January 2017 and October 2018. The primary outcome was the procedure time, and the secondary outcomes were other factors, including the en bloc resection rate, complete resection rate, curative resection rate, and rate of adverse events. RESULTS: Among 215 patients, 29 underwent H-ESD and 186 underwent C-ESD; 29 pairs were created by propensity score matching. In the H-ESD group, 82.8% of lesions met the absolute indication [mucosal lesions limited to 20-mm diameter, dominated by differentiated adenocarcinoma without ulcer (scar)] for endoscopic resection (ER). As a result, the procedure time of H-ESD was significantly shorter than that of C-ESD [20 (interquartile range, 12-27) min versus 40 (30-50) min; p < 0.001]. There was no significant difference in the secondary outcomes between the two groups. CONCLUSION: H-ESD contributed to reduced procedure time. Therefore, H-ESD could be an alternative endoscopic treatment for gastric neoplasms when the lesion fulfils the absolute indication for ER.

Efficacy of traction, using a clip-with-thread, for esophageal endoscopic submucosal dissection for esophageal lesions with fibrosis in an ex vivo pig training model.

BACKGROUND/AIMS: Endoscopic submucosal dissection (ESD) of recurrent esophageal carcinoma is technically difficult to perform due to submucosal fibrosis that develops after definitive chemoradiation therapy. Therefore, our aim was to evaluate the usefulness of clip-with-thread traction for ESD of esophageal lesions with submucosal fibrosis. MATERIALS AND METHODS: Four endoscopists excised 16 lesions by ESD in an ex vivo pig training model. Mock lesions (30 mm in diameter) were created, including a 10-mm area of submucosal fibrosis in the center of each lesion. Each endoscopist performed two ESDs with traction (ESD-T) and two without traction (ESD-N). The primary outcome was the time required for submucosal dissection. Secondary outcomes were the rate of en bloc (complete) resection and perforation during the procedure, and the total amount of solution injected. RESULTS: All esophageal ESDs were completed. The median dissection time was significantly shorter for the ESD-T group (median 12.5 min, interquartile range 10.2-14.5) when comparing to the ESD-N group (median 18.0 min, interquartile range 14.6-19.2) (P=0.040). The en bloc resection rate was 100% in both groups, with a rate of complete resection of 87.5% and a rate of perforation of 37.5% for both groups. The median amount of solution injected was not significantly different between the ESD-T (18.0 ml) and ESD-N (20.5 ml) groups (P=0.526). CONCLUSION: Clip-with-thread traction improved the performance of ESD for lesions with submucosal fibrosis. However, the method might not reduce the risk of perforation, which remains an important clinical issue to resolve.

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.