RESUMO
BACKGROUND AND AIMS: 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 is limited. METHODS: PubMed and Cochrane databases were reviewed for relevant studies from their inception to October 31, 2023. Studies comparing T-ESD or PCM-ESD (T/PCM-ESD) to 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. RESULTS: Eight observational studies (359 patients - T/PCM-ESD, 670 patients - C-ESD) were included. T/PCM-ESD was associated with a significantly faster dissection speed (Mean Difference: 4.42 mm2/min, 95% 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% confidence interval (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%). While 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. CONCLUSION: T/PCM-ESD facilitates faster and safer gastric ESD than conventional ESD with comparable en bloc resection, R0 resection, and recurrence rates. A future randomized controlled control trial is required.
RESUMO
BACKGROUND AND AIMS: Colorectal endoscopic submucosal dissection (ESD) is challenging despite its usefulness. Underwater ESD (UESD) provides better traction and a clearer view of the submucosal layer than conventional ESD (CESD). This study compared the efficiency of UESD and CESD for large (20-50 mm) laterally spreading tumor (LST). METHODS: Preplanned sample size was calculated from our previous experience. As a results, 28 patients were required to UESD group or CESD group, respectively. The primary outcome was total procedure time while the secondary outcome was dissection speed. RESULTS: Fifty-six patients were enrolled and a total of 28 patients were assigned to each group. The mean size of LST was 31.6 mm and 31.3 mm in the UESD and CESD group, respectively. Fibrosis was observed in 67.9% and 60.7% patients in the UESD and CESD group. Total procedure time (mean [SD]) for the UESD group was significantly shorter than that for the CESD group, respectively (49.5 minutes [20.3] vs 75.7 minutes [36.1]; mean difference, -26.2 minutes; 95% CI, -42.0 to -10.5). Dissection speed of the UESD group was significantly faster than that of the CESD group (21.9 mm2/min [6.9] vs 15.2 mm2/min [7.3]; mean difference, 6.7 mm2/minutes; 95% CI, 2.8-10.4). There was no difference between groups in the R0 resection rate or en bloc resection rate. No perforations were observed in either group. CONCLUSIONS: UESD was superior to CESD in total procedure time and dissection speed. UESD can be recommended as the preferred method for the resection of large LST.
RESUMO
BACKGROUND: Endoscopic 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. METHODS: This 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. DISCUSSION: This 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 REGISTRATION: UMIN-CTR UMIN000041244 . Registered on July 29, 2020.