BACKGROUND: Most mucosal defects that occur with endoscopic submucosal dissection (ESD) can be closed completely using endoscopic clips. However, benefits of such closure in wound healing are unknown. A randomized controlled study evaluated the efficacy of closure with clips compared with no closure. METHOD: Twenty-eight patients who had undergone ESD were randomly divided into two groups: closure (n = 14) and non-closure groups (n = 14). In the closure group, the mucosal defect resulting from ESD was closed using endoscopic clips. Four weeks after ESD, defects in both groups were observed by colonoscopy. Efficacy was based on change in the area of the defect, percentage of complete healing in each group, and complications. RESULT: Data were analyzed for 26 of the 28 patients (13, closure group; 13, non-closure group). All tumors were resected en bloc by ESD without bleeding or perforation. In the closure group, the area of the defect just after ESD was 677 ± 306 mm(2) (mean ± SD) as determined by the size of the removed lesion and had decreased to 2.17 ± 4.51 mm(2) at 4 weeks after ESD (reduction, 99.7 %), but in the non-closure group that area was 790 ± 221 mm(2) and had decreased to 27.42 ± 25.72 mm(2) at 4 weeks post-ESD (reduction, 96.2 %). The reduction rate was significantly higher in the closure than in the non-closure group (99.7 vs. 96.2 %, p = 0.010). Complete healing was 69.2 % in the closure group vs. 7.7 % in the non-closure group (p = 0.005). Multivariate analysis showed that closure of the mucosal defect (OR 24.029, 95 % CI 2.09-276.15, p = 0.011) was an independent factor associated with complete healing at 4 weeks after ESD. Delayed perforation or post-ESD bleeding was not observed in any participant. CONCLUSION: Use of endoscopic clips for closure of defects after ESD is safe and efficacious in accelerating wound healing. TRIAL REGISTRATION: UMIN-CTR UMIN000009112.
RCT Entities:
BACKGROUND: Most mucosal defects that occur with endoscopic submucosal dissection (ESD) can be closed completely using endoscopic clips. However, benefits of such closure in wound healing are unknown. A randomized controlled study evaluated the efficacy of closure with clips compared with no closure. METHOD: Twenty-eight patients who had undergone ESD were randomly divided into two groups: closure (n = 14) and non-closure groups (n = 14). In the closure group, the mucosal defect resulting from ESD was closed using endoscopic clips. Four weeks after ESD, defects in both groups were observed by colonoscopy. Efficacy was based on change in the area of the defect, percentage of complete healing in each group, and complications. RESULT: Data were analyzed for 26 of the 28 patients (13, closure group; 13, non-closure group). All tumors were resected en bloc by ESD without bleeding or perforation. In the closure group, the area of the defect just after ESD was 677 ± 306 mm(2) (mean ± SD) as determined by the size of the removed lesion and had decreased to 2.17 ± 4.51 mm(2) at 4 weeks after ESD (reduction, 99.7 %), but in the non-closure group that area was 790 ± 221 mm(2) and had decreased to 27.42 ± 25.72 mm(2) at 4 weeks post-ESD (reduction, 96.2 %). The reduction rate was significantly higher in the closure than in the non-closure group (99.7 vs. 96.2 %, p = 0.010). Complete healing was 69.2 % in the closure group vs. 7.7 % in the non-closure group (p = 0.005). Multivariate analysis showed that closure of the mucosal defect (OR 24.029, 95 % CI 2.09-276.15, p = 0.011) was an independent factor associated with complete healing at 4 weeks after ESD. Delayed perforation or post-ESD bleeding was not observed in any participant. CONCLUSION: Use of endoscopic clips for closure of defects after ESD is safe and efficacious in accelerating wound healing. TRIAL REGISTRATION: UMIN-CTR UMIN000009112.
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