Conventional ESD Research Articles

Traction-assisted endoscopic submucosal dissection of colonic lesions: a North American experience

Background and aimsTraction-assisted ESD (TA-ESD) is a proposed technique to improve the efficiency and efficacy of ESD. Multiple studies primarily from Asian centers yielded mixed results in terms of procedure time, en bloc resection rate and R0 resection rate in comparison to conventional ESD (C-ESD). We performed the first comparison of TA-ESD and C-ESD at a high-volume North American center. MethodsThis was a retrospective cohort matched study of all patients who underwent colonic ESD at a single center in the United States by a single operator. The study group were patients who underwent TA-ESD and were matched with a C-ESD case on a 1:1 basis based upon location within the colon, lesion size, and scope stabilization device usage. The baseline characteristics and procedure-related outcomes were compared between the groups. Results138 colonic ESD cases were included (69 TA-ESD, 69 C-ESD). There were no significant differences in the baseline characteristics between the groups. Mean procedure time was 91.0 min (SD 32.5) for TA-ESD and 85.4 min (SD 39.3) for C-ESD (p=0.36). En bloc resection was achieved in 69 (100%) of the TA-ESDs and 67 (97.1%) of the C-ESDs (p=0.15). R0 resection was achieved in 52 (75.4%) of the TA-ESDs and 48 (69.6%) of the C-ESDs (p=0.45). ConclusionWe did not show a significant difference in procedure time, en bloc resection, R0 resection, or adverse events. Further randomized prospective studies that are sufficiently powered and stratified by operator experience level are needed to further elucidate the utility of the technique.

The efficacy and safety of per-nasal "GTS partner" assisted traction technique for gastric endoscopic submucosal dissection: a prospective single-center randomized clinical trial.

Since the snare traction-assisted ESD has been proven effective in treating flat lesions of the digestive tract, we modified and innovated the process and path of the traditional snare entering the digestive tract, aiming to investigate the efficacy and safety of using the per-nasal "GTS partner" assisted traction technology in gastric ESD. Patients with superficial gastric neoplasms were prospectively enrolled between November 2022 and May 2024 and randomly assigned to a conventional ESD (C-ESD) group or per-nasal "GTS partner" traction-assisted ESD (GTS-ESD) group. The primary outcomes were procedure time and dissection speed. The GTS-ESD and C-ESD groups included 40 patients each, and all the enrolled patients underwent the assigned treatment. The median procedure time in the GTS-ESD group was shorter than that in the C-ESD group (38min vs. 48min; P < 0.001), and the mean resection speed of the GTS-ESD group was faster than that of the C-ESD group (17.95 mm2/min vs. 11.86 mm2/min; P = 0.033). The median resection speed of lesions ≥ 20mm was faster by GTS-ESD than by C-ESD (21.21 mm2/min vs. 12.83 mm2/min, P = 0.002). The en bloc resection rate (100% vs 100%) and R0 resection rate (100% vs. 97.5%) were similar between the two groups. There were no adverse events related to the per-nasal "GTS partner" assisted traction technology, and the traction technology had little interference with the endoscopist. The per-nasal "GTS partner" assisted traction technique can significantly shorten the gastric ESD procedure time and has the advantages of no damage to normal mucosa and adjustable traction direction, especially in the lower 1/3 of the stomach or lesions with a diameter of ≥ 20mm.

Conventional versus rubber band traction-assisted endoscopic submucosal dissection for rectal neuroendocrine tumors: a single-center retrospective study (with video)

BackgroundEndoscopic submucosal dissection (ESD) is a safe and effective technique for the treatment of gastrointestinal tumors, including rectal neuroendocrine tumors (r-NETs). However, the relative advantages of traction-assisted ESD for the treatment of small rectal lesions are still debated.AimsWe conducted a study to compare the efficacy and safety of rubber band traction-assisted ESD (RBT-ESD) to conventional ESD (C-ESD).MethodsThis study retrospectively analyzed consecutive patients with r-NET treated with ESD between October 2021 and October 2023. Our study assessed differences between the groups in the complete resection rate of lesions, muscular layer injury, surgical complications, operation time, resection speed, time to liquid diet, postoperative hospital stay, hospital cost, and recurrence rate.ResultsA total of 119 patients with r-NETs participated in this study (RBT-ESD group, n = 27; C-ESD group, n = 92). The operation time in RBT-ESD group was shorter than in C-ESD group, but the difference was not statistically significant (16.0 min [9.0–22.0 min] vs. 18.0 min [13.3–27.0 min], P = 0.056). However, the resection speed was significantly faster in the RBT-ESD group (6.7 vs. 4.1 mm2/min, P = 0.005). Furthermore, the RBT-ESD group showed significantly less muscular layer injury (P = 0.047) and faster diet recovery (P = 0.035). No significant differences were observed in the complete resection rate, surgical complications, postoperative hospital stay, hospital cost, or recurrence rate between the two groups.ConclusionFor r-NETs of < 2 cm in size, the RBT method did not significantly shorten the operation time but resulted in faster resection speed, less muscular layer injury, and earlier postoperative recovery to a liquid diet.Graphical

Tunneled or Pocket Creation Method Versus Conventional Endoscopic Submucosal Dissection for Gastric Lesions: A Systematic Review and Meta-analysis

Tunneled endoscopic submucosal dissection (T-ESD) and pocket creation-method ESD (PCM-ESD) are considered to have technical advantages over conventional ESD (C-ESD). However, data comparing these techniques for ESD of gastric lesions are limited. PubMed and Cochrane databases were reviewed for relevant studies from their inceptions to October 31, 2023. Studies comparing T-ESD or PCM-ESD (T/PCM-ESD) with C-ESD for gastric lesions were included. The primary outcomes were dissection speed and en-bloc resection. Secondary outcomes were R0 resection, recurrence, perforation, and post-ESD bleeding. A random effects meta-analysis was conducted. Eight observational studies (359 patients with T/PCM-ESD, 670 patients with C-ESD) were included. T/PCM-ESD was associated with a significantly faster dissection speed (mean difference, 4.42mm2/min; 95% confidence interval [CI], 2.05-6.79; I2= 79%). There were no significant differences between the groups in terms of en-bloc resection (risk ratio [RR], 1.01; 95% CI, 1.00-1.03; I2= 0%), R0 resection (RR, 1.03; 95% CI, 0.99-1.07; I2= 0%), and recurrence (RR, 0.73; 95% CI, 0.14-3.84; I2= 0%). Although T/PCM-ESD was associated with a significantly lower risk of perforation (RR, 0.21; 95% CI, 0.06-0.80; I2= 0%), post-ESD bleeding rates were not significantly different. T/PCM-ESD facilitates faster and safer gastric ESD than C-ESD, with similar en-bloc resection, R0 resection, and recurrence rates. A future randomized controlled control trial is required.

Hybrid Versus Conventional Colorectal Endoscopic Submucosal Dissection: A Multicenter Randomized Controlled Trial (Short-Endoscopic Submucosal Dissection).

Hybrid endoscopic submucosal dissection (H-ESD), which utilizes ESD knife along with snare-based resection, has been developed to overcome the technical complexity of conventional ESD (C-ESD). The aim of this study was to compare the therapeutic outcomes of H-ESD vs C-ESD for nonpedunculated colorectal lesions ≥20 mm in size. We conducted a multicenter randomized controlled trial to compare H-ESD and C-ESD (Short-ESD trial). Patients with colorectal lesions between 20 and 50 mm in size were randomly assigned (1:1) to H-ESD or C-ESD. Primary outcome was procedure time/speed. Secondary outcomes were en bloc and complete (R0) resection rates and adverse event rates. A total of 89 patients (median age 63 years; 49.3% women) with the median polyp size of 30 mm underwent H-ESD (n = 40) and C-ESD (n = 49). The mean procedure time of H-ESD was significantly shorter than that of C-ESD (41.1 ± 16.3 vs 54.3 ± 28.2 minutes; P = 0.007). The en bloc and R0 resection rates trended lower in the H-ESD vs C-ESD groups (77.5% vs 87.8%; P = 0.26% and 72.5% vs 79.6%; P = 0.46) without reaching statistical significance. Adverse event rate was similar between H-ESD and C-ESD (10% vs 8.2%; P = 1.00). Both H-ESD and C-ESD were safe and effective for resection of large colorectal lesions. H-ESD was associated with a shorter procedure time. H-ESD may represent a viable alternative to C-ESD, with the main advantage being easy applicability of a snare-based technique for colorectal lesions. Future studies are needed to further define the most suitable lesions for H-ESD, as to optimize efficiency and safety without compromising resection outcomes. ClinicaTrials.gov NCT NCT05347446.

Safe and effective hybrid endoscopic submucosal dissection with ALL IN ONE snare in porcine gastric model (with video)

This study aimed to evaluate the safety and efficiency of hybrid endoscopic submucosal dissection (H-ESD) using a newly developed ALL IN ONE (AIO) snare. This was a matched control study in a porcine model. Five paired simulated stomach lesions 2–2.5 cm in size were removed by H-ESD using an AIO snare or conventional ESD (C-ESD) using an endoscopic knife. The outcomes of the two procedures were compared, including en-bloc resection rates, procedure times, intraprocedural bleeding volumes, muscular injuries, perforations, thicknesses of the submucosal layer in resected specimens, and stomach defects. All simulated lesions were resected en-bloc. Specimens resected by H-ESD and C-ESD were similar in size (7.68 ± 2.92 vs. 8.42 ± 2.42 cm2; P = 0.676). H-ESD required a significantly shorter procedure time (13.39 ± 3.78 vs. 25.99 ± 4.52 min; P = 0.031) and submucosal dissection time (3.99 ± 1.73 vs. 13.1 ± 4.58 min; P = 0.003) versus C-ESD; H-ESD also yielded a faster dissection speed (241.37 ± 156.84 vs. 68.56 ± 28.53 mm2/min; P = 0.042) and caused fewer intraprocedural bleeding events (0.40 ± 0.55 vs. 3.40 ± 1.95 times/per lesion; P = 0.016) than C-ESD. The thicknesses of the submucosal layer of the resected specimen (1190.98 ± 134.07 vs. 1055.90 ± 151.76 μm; P = 0.174) and the residual submucosal layer of the stomach defect (1607.94 ± 1026.74 vs. 985.98 ± 445.58 μm; P = 0.249) were similar with both procedures. The AIO snare is a safe and effective device for H-ESD and improves the treatment outcomes of gastric lesions by shortening the procedure time.

A prospective randomized trial comparing the pocket-creation method and conventional method of endoscopic submucosal dissection in early gastric cancers and precancerous lesions

BackgroundEndoscopic submucosal dissection (ESD) is widely used as a standard treatment regimen for early gastric cancers (EGCs). However, such an approach is time consuming and has a high risk of perforation and bleeding in some corner-site lesions because of the obscured view and difficulty in submucosal lifting. The newly developed pocket-creation method (PCM) provides a clearer view and better traction of the submucosal layer than conventional ESD (c-ESD). Nevertheless, no prospective randomized study has evaluated the efficacy of the PCM in EGCs and precancerous lesions. MethodsThis was a prospective randomized controlled trial. Patients with superficial gastric neoplastic lesions ≥ 20 mm were randomly assigned to the PCM-ESD group or c-ESD group. The primary outcome was dissection speed. ResultsThere were 28 patients in the PCM-ESD group and 27 in the c-ESD group. The median dissection speed was significantly higher in the PCM-ESD group than in the c-ESD group (21.5 mm2/min vs 14.3 mm2/min, P < .001). Meanwhile, the operation time in the PCM-ESD group was significantly shorter than that in the c-ESD group (30 vs 40 min, P = .047). In multiple linear regression analysis, the treatment method was independently associated with the resection speed of ESD. ConclusionPCM-ESD was an effective and safe treatment for EGCs and precancerous lesions.

Efficacy of the traction method for gastric endoscopic submucosal dissection: a randomized controlled trial (with videos)

Background/AimsTo overcome the technical difficulties associated with gastric ESD, a novel traction device that can alter the direction of traction was developed. Here, we compared the efficacy and safety of conventional ESD with that of traction-assisted gastric ESD. MethodsPatients with a single gastric epithelial neoplasm were randomized to receive conventional (n=75) or traction-assisted (n=73) gastric ESD. The primary outcome was ESD procedure time. ResultsThere were no differences between the conventional and traction-assisted groups with respect to treatment results or complications. The mean procedure time was similar for both groups (78.9 vs. 88.3 min, respectively; p=0.3); however, times for the traction device tended to be shorter for lesions in the lesser curvature of the upper or middle stomach (84.6 vs. 123.2 min, respectively; p=0.057). ConclusionsTraction-assisted ESD for lesions in the lesser curvature of the upper or middle stomach were shorter, thereby reducing the procedure time of conventional ESD.

Planned Hybrid Endoscopic Submucosal Dissection as Alternative for Colorectal Neoplasms: A Propensity Score-Matched Study.

Hybrid endoscopic submucosal dissection (H-ESD), a modified ESD with a snare, has become increasingly utilized to overcome the limitations of conventional ESD (C-ESD). This study aimed to compare the efficacy and safety of Planned H-ESD and C-ESD for colorectal lesions. Propensity score matching was performed to control for confounding variables in this retrospective study. Outcomes included en bloc resection and complete resection (R0) rates, procedure time, adverse event rates, and local recurrence rate. 1286 lesions were enrolled in the study. After matching, 263 lesions were assigned to each group. The Planned H-ESD group has lower en bloc rate but similar R0 resection rate compared to the C-ESD group (90.9% vs 98.1%, P = 0.001; 77.2% vs 77.9%, P = 0.917). The median procedure time was shorter in the Planned H-ESD group (27.0 min vs 35.0 min, P = 0.001). There were no significant differences in adverse events rates or local recurrence rate. Subgroup analysis based on lesion size revealed that a significantly lower en bloc resection rate in the Planned H-ESD group compared to the C-ESD group for lesions ≥ 40mm (71.0% vs 94.3%, P = 0.027), but there was no significant difference for lesions < 40mm. The Planned H-ESD has a lower en bloc resection rate but a similar R0 resection rate, adverse event rates, local recurrence rate, and shorter procedure duration. Compared to C-ESD, Planned H-ESD presents advantages for managing colorectal neoplasms below 40mm.

Hybrid endoscopic submucosal dissection as a salvage option for difficult colorectal conventional endoscopic submucosal dissection.

When total submucosal dissection is difficult to achieve during conventional colorectal endoscopic submucosal dissection (C-ESD), the lesion can be resected by final snaring through salvage hybrid ESD (SH-ESD). This study aimed to examine the outcomes of SH-ESD and identify its indications that could achieve en bloc resection. We recruited 1039 consecutive patients with colorectal lesions that underwent ESD at Hiroshima University Hospital between January 2015 and December 2020. C-ESD was attempted thoroughly in 924 lesions (C-ESD group, including 9 lesions in which ESD was discontinued), and SH-ESD was performed owing to some difficulties in 115 lesions (SH-ESD group). Risk factors for incomplete resection by SH-ESD and ESD discontinuation were evaluated using multivariate analysis. The outcomes were compared between cases with remaining undissected submucosa of < 20mm in diameter in the SH-ESD and C-ESD groups, using propensity score matching. Multivariate analysis revealed that a procedure time > 80min and remaining undissected submucosa ≥ 20mm in diameter were significant risk factors for incomplete resection after SH-ESD and ESD discontinuation. By propensity score matching analysis, procedure time was significantly shorter in the SH-ESD group with remaining undissected submucosa < 20mm in diameter than in the C-ESD group (71min vs. 90min, p = 0.0053), although no significant difference was found in the en bloc resection rate (94% vs. 87%, p = 0.0914). SH-ESD can be an alternative surgical method when conventional ESD is difficult to continue in cases in which the remaining undissected submucosa is < 20mm in diameter.

ESD with elastic ring traction is more effective and safer than conventional ESD in large proximal colon neoplastic lesions: a retrospective cohort study (with video)

Background and aimsColorectal endoscopic submucosal resection (ESD), especially ESD in proximal colon, has always been challenging. We invented a novel elastic ring as a traction method to facilitate ESD. Our study aims to compare the safety and effectiveness of ESD with in vivo traction and conventional ESD without traction in the treatment of large proximal colon neoplastic lesions.MethodsThis retrospective cohort study included consecutive patients with large (≥ 20 mm in their maximal diameter) proximal colon neoplastic lesions who underwent ESD with in vivo elastic ring traction or conventional ESD without traction in our endoscopy center between June 2018 and April 2022 by one experienced endoscopist.ResultsThe ESD with traction group has lower overall complication rate and lower perforation rate than those in the conventional ESD group (0% vs 14.71%, P = 0.021; 0% vs 11.76%, P = 0.048, respectively), and the differences are statistically significant. Although there are no significant differences in the rates of en bloc resection and R0 resection and bleeding rate, ESD with traction group still had higher en bloc resection and R0 resection rates and lower bleeding rate than conventional ESD group without traction (100% vs 94.12%, P = 0.226; 94.59% vs 85.29%, P = 0.189, 8.82% vs 2.70%, P = 0.276, respectively).ConclusionESD with elastic ring traction is potentially more effective and safer than conventional ESD in the treatment of large proximal colon neoplastic lesions. Further large, prospective controlled studies are needed to fully evaluate this novel method.

321. ESD AND ELPS A NOVEL MINIMALLY INVASIVE TREATMENT FOR MULTI-EPISODE SUPERFICIAL ESOPHAGEAL SCC AND 2ND PRIMARY HYPOPHARYNGEAL SCC:A CASE REPORT

Abstract Background Esophageal SCC is a common cancer worldwide. Major risk factors were tobacco and alcohol use. It’s also a cause of head and neck cancers, particularly hypopharyngeal SCC. ESD was established as standard procedure for curative early esophageal SCC. However, conventional ESD for hypopharyngeal lesions is technically difficult. This report describes a patient who had superficial hypopharyngeal SCC following multiple esophageal ESD sessions. This VDO presentation shows how to perform safe ELPS and achieve oncological purposes. Methods A 77-year-old Thai man. He had primary cervical esophageal SCC and 1 month after complete response from definite CCRT, he began presenting four other recurrent episodes of superficial esophageal SCC in the lower, middle, and two times of cervical regions over a 3-year period. ESD and APC were applied and showed a complete response. The last endoscopic finding also revealed of superficial hypopharyngeal SCC and ELPS was decided by the following step: curve laryngoscope placement, laryngeal packing, lesion identification and marking, submucosal injection, circumferential incision, submucosal dissection, and bleeding control. The specimen was removed transorally and sent for pathological examination. Result The operation was successful without complications. The patient was able to start a liquid diet on day 1 and a soft meal on second day post operation. He was discharged on 3rd day without any complications. The pathological report was moderated differentiate SCC with positive deep margin, so he was planned for further RT. Conclusion ELPS provided good visualization, which led to a sufficient working space for resection. The procedure was safe and feasible for superficial hypopharyngeal lesions and exhibited good oncological outcomes, preserving both swallowing and phonation functions.

Clinical outcomes of esophageal granular cell tumors with different endoscopic resection methods

Esophageal granular cell tumors (GCTs), the second most common subepithelial tumors (SETs) of the esophagus, are potentially malignant with no definite management guidelines available. We retrospectively enrolled 35 patients with endoscopically resected esophageal GCTs between December 2008 and October 2021 and evaluated the clinical outcomes from the various methods performed. Several modified endoscopic mucosal resections (EMRs) were performed for treating esophageal GCTs. Clinical and endoscopic outcomes were evaluated. Mean age of patients was 55.8 ± 8.2, with majority being men (57.1%). Mean tumor size was 7.2 ± 2.6 mm, most (80.0%) were asymptomatic and present in the distal third of the esophagus (77.1%). Endoscopic characteristics predominantly included broad-based (85.7%) and whitish-to-yellowish color changes (97.1%). Endoscopic ultrasound (EUS) of 82.9% of the tumors revealed homogeneous hypoechoic SETs originating from the submucosa. The five endoscopic treatment methods used were: ligation-assisted (77.1%), conventional (8.7%), cap-assisted (5.7%), and underwater (5.7%) EMRs and ESD (2.9%). Mean procedure time was 6.6 ± 2.1 min, and no procedure-associated complications were noted. The en-bloc and complete histologic resection rates were 100% and 94.3%, respectively. No recurrences were noted during follow-up, and no significant differences in the clinical outcomes of the different methods of endoscopic resection were found. Based on tumor characteristics and therapeutic outcomes, modified EMR methods can be effective and safe. However, there were no significant differences in the clinical outcomes of the different methods of endoscopic resection.

Underwater endoscopic submucosal dissection for colorectal tumors decreases the incidence of post-electrocoagulation syndrome.

Underwater endoscopic submucosal dissection (U-ESD) is a recently developed procedure that has the potential to prevent post-ESD coagulation syndrome (PECS) owing to its heat-sink effect. We aimed to clarify whether U-ESD decreases the incidence of PECS compared with conventional ESD (C-ESD). A total of 205 patients who underwent colorectal ESD (C-ESD: 125; U-ESD: 80) were analyzed. Propensity score matching analysis was performed to adjust for patient backgrounds. Ten C-ESD and two U-ESD patients with muscle damage or perforation during ESD were excluded when comparing PECS. The primary outcome was to compare the incidence of PECS between the U-ESD and C-ESD groups (54 matched pairs). Secondary outcomes were to compare procedural outcomes between the C-ESD and U-ESD groups (62 matched pairs). Among the 78 patients who underwent U-ESD, PECS occurred in only one patient (1.3%). Adjusted comparisons between the U-ESD and C-ESD groups demonstrated a significantly lower incidence of PECS in the U-ESD group (0% vs 11.1%; P=0.027). Median dissection speed was significantly faster in the U-ESD than in the C-ESD group (10.9mm2 /min vs 6.9mm2 /min; P<0.001). En bloc and complete resection rates were 100% in the U-ESD group. Although perforation and delayed bleeding occurred in one patient each (1.6%) as adverse events in the U-ESD group, there were no differences compared with the C-ESD group. Our study demonstrates that U-ESD effectively decreases the incidence of PECS and is a faster and safer method for colorectal ESD.

Comparison of efficiency and safety between dual-clip and rubber band-assisted ESD and conventional ESD for colonic lateral spreading tumors (LSTs) with different levels of technical difficulty: a retrospective case–control study

BackgroundDual-clip and rubber band-assisted endoscopic submucosal dissection (DCRB-ESD) is a useful technique in the management of lateral spreading tumors (LSTs) of the colon and is suggested by researchers compared with conventional ESD (C-ESD). The aim of this retrospective study is to further analyze the efficiency and safety of DCRB-ESD in a setting with varying technical difficulties.MethodsPatients who underwent endoscopic treatment (DCRB-ESD or C-ESD) due to LSTs between Jan 1st, 2019 and Jan 1st, 2022, were retrospectively collected. Patients were classified into the following two groups: the DCRB-ESD group (n = 46) and the C-ESD group (n = 81). Baselines were compared and propensity score matching (PSM) was employed to manage the heterogeneity. The technical difficulty and outcomes of the two groups were evaluated based on a semiquantitative model (CS-CRESD) previously described.ResultsThe baseline characteristics of the two groups were balanced except sex and LST classification before PSM and were corrected after PSM. The median ESD operation time of DCRB-ESD was shorter than that of C-ESD (32 vs 41 and 30 vs 44 before and after PSM respectively, P < 0.05). The operation durations of cases with different CS-CRESD scores were different (P < 0.05). In the subgroup with a score of 0, DCRB-ESD showed no advantage than C-ESD in terms of operation duration before and after PSM. In subgroups with a score of 1–3, DCRB-ESD was faster than C-ESD. In subgroups with a score of 4–5, the between-group operation duration was not significantly different due to the limited number of cases, although the median time of DCRB-ESD was shorter. The R0 resection rates, curative resection, complications, and additional surgery in both groups were not significantly different. No adverse events, such as a clip falling off or rubber band rupturing occurred during this study.ConclusionDCRB-ESD was an efficient and safe procedure in the management of colonic LSTs. With DCRB-ESD, the operation duration of difficult cases can be shortened without sacrificing complication risk. However, not all cases would benefit from DCRB-ESD. For easy cases (CS-CRESD score = 0), DCRB-ESD may not be prior to C-ESD by experienced endoscopists. A pre-ESD technical difficulty evaluation was recommended to decide whether to perform DCRB-ESD or not.

“String-to-ring” traction technique for endoscopic submocosal dissection in the treatment of rectal tumors

The results for “string-to-ring” ESD and conventional ESD were compared in present study. The “string-to-ring” method was developed to create traction using a thread, fixed to the edge of the tumor, that is moved through a ring, located on the clip on the opposite wall. The study included 41 ESDs of the lesions larger than 3 cm in the rectum, that were performed from October 2016 to June 2021. Patients were divided into two groups (“string-to-ring” ESD, n = 19; conventional ESD, n = 22). Time of the procedure and the frequency of complications were evaluated. Analyzing the obtained data, the “string-to-ring” method allowed to shorten the operation time (from 85,8 ± 17,5 to 63,6 ± 15,3 min), reduce the rate of intraoperative bleeding and perforations from 19% to 0%. At the conclusion, ESD with “string-to-ring” traction—a promising technique with potential for clinical application. The advantage of this method provide better visualizing the submucosal layer due to the direction of gravity. This method facilitates ESD, reduces procedure time and the number of intraoperative complications—bleeding and perforation.

Comparison of the procedure time differences between hybrid endoscopic submucosal dissection and conventional endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for a multi-center randomized controlled trial (Hybrid-G trial)

BackgroundEndoscopic submucosal dissection (ESD) is widely accepted as a local treatment for gastrointestinal tract tumors. As a simplified endoscopic procedure, hybrid ESD (H-ESD) has been performed for colorectal neoplasms in recent times. However, whether H-ESD is superior to conventional ESD (C-ESD) for patients with early gastric neoplasms (EGN) remains unclear. In this trial, we will compare the treatment outcomes of H-ESD and C-ESD. We hypothesize that the procedure time for H-ESD is shorter than that for C-ESD.MethodsThis is an investigator-initiated, multi-center, prospective, randomized, open-label, parallel-group trial to be conducted beginning in August 2020 at nine institutions in Japan. We will determine if H-ESD is superior to C-ESD in terms of procedure time in patients with EGN diagnosed as macroscopically intramucosal (T1a) differentiated carcinoma ≤ 20 mm in diameter without ulcerative findings according to current Japanese gastric cancer treatment guidelines. A total of 82 patients will be recruited and randomly assigned to either the C-ESD or the H-ESD group. The primary outcome is ESD procedure time. Secondary outcomes include mucosal incision, time and speed of submucosal dissection, en bloc resection, complete resection, curability, adverse events related to the ESD procedure, extent of dissection before snaring, volume of injection solution, number and time of hemostasis, thickness of the submucosal layer in the resected specimen, and handover to another operator. The stated sample size was determined based on the primary outcome. According to a previous report comparing the procedure times of C-ESD and H-ESD, we hypothesized that H-ESD would provide a 0.2 reduction in logarithmically concerted procedure time (−37%). We estimated that a total of 82 participants were needed to reach a power of 80% for a t-test with a significance level of 0.05 and considering a 10% dropout.DiscussionThis trial will provide high-quality data on the benefits and risks of H-ESD for EGN patients. The results of this study could lead to improved outcomes in patients with EGN undergoing ESD. The results will be presented at national and international meetings and published in peer-reviewed journals.Trial registrationUMIN-CTR UMIN000041244. Registered on July 29, 2020.

Comparisons of outcomes between ProKnife injection endoscopic submucosal dissection and conventional endoscopic submucosal dissection for large gastric lesions in ex vivo porcine model study: A randomized controlled trial

ObjectiveTo compare treatment outcomes between injection endoscopic submucosal dissection using ProKnife (P‐ESD) and conventional ESD (C‐ESD) for gastric lesions.MethodsIn this randomized controlled trial, we compared treatment outcomes of P‐ESD and C‐ESD for simulated gastric lesions ≥3 cm in resected porcine stomachs. Predictive factors associated with ESD difficulties were investigated using logistic regression analysis.ResultsSeventy lesions were screened; however, two lesions were excluded. A total of 12 endoscopists performed 68 ESDs: 34 P‐ESDs and 34 C‐ESDs. The ESD procedure time of P‐ESD (36.3 [28.4–46.8] min) was significantly shorter than that of C‐ESD (46 [36.4–64.6] min; p = 0.0014). The technical success rates did not differ between the P‐ESD and C‐ESD groups (en bloc resection rate, 100% in both groups; complete resection rate, 94.1% and 85.3%, respectively; p = 0.23). The number of injections during P‐ESD (7.5 [6–10] times) was significantly higher than during C‐ESD (4 [3–5] times; p < 0.001), but the total volume of injected solution during P‐ESD (20 [16–26.3] ml) was significantly smaller than during C‐ESD (27.5 [20–31.5] ml; p = 0.0019). In multivariate analysis, less ESD experience (odds ratio [OR], 3.9) and selection of C‐ESD as the ESD method (OR, 3.8) were independent predictive factors associated with ESD difficulties.ConclusionsCompared with C‐ESD, P‐ESD had a shorter procedure time but also allowed for notable technical success and safety.

Multi-loop traction device facilitates gastric endoscopic submucosal dissection: ex vivo pilot study and an inaugural clinical experience

BackgroundEndoscopic submucosal dissection (ESD) is technically difficult and requires considerable training. The authors have developed a multi-loop traction device (MLTD), a new traction device that offers easy attachment and detachment. We aimed to evaluate the utility of MLTD in ESD.MethodsThis ex vivo pilot study was a prospective, block-randomized, comparative study of a porcine stomach model. Twenty-four lesions were assigned to a group that undertook ESD using the MLTD (M-ESD group) and a group that undertook conventional ESD (C-ESD group) to compare the speed of submucosal dissection. In addition, the data of consecutive 10 patients with eleven gastric lesions was collected using electronic medical records to clarify the inaugural clinical outcomes of gastric ESD using MLTD.ResultsThe median (interquartile range) speed of submucosal dissection in the M-ESD and C-ESD groups were 141.5 (60.9–177.6) mm2/min and 35.5 (20.8–52.3) mm2/min, respectively; submucosal dissection was significantly faster in the M-ESD group (p < 0.05). The rate of en bloc resection and R0 resection was 100% in both groups, and there were no perforation in either group. The MLTD attachment time was 2.5 ± 0.9 min and the MLTD extraction time was 1.0 ± 1.1 min. Clinical outcomes of MLTD in gastric ESD were almost the same as those of ex vivo pilot study.ConclusionsMLTD increased the speed of submucosal dissection in ESD and was similarly effective when used by expert and trainee endoscopists without perforation. MLTD can potentially ensure a safer and faster ESD.

S1007 Length of Stay for Double Balloon Interventional Platform Assisted ESD vs Conventional ESD: A Comparative Analysis

S1007 Length of Stay for Double Balloon Interventional Platform Assisted ESD vs Conventional ESD: A Comparative Analysis