Efficacy of the pocket-creation method with a traction device in endoscopic submucosal dissection for residual or recurrent colorectal lesions.

BACKGROUND/AIMS: Endoscopic submucosal dissection (ESD) for residual or recurrent colorectal lesions after incomplete resection is challenging because of severe fibrosis. This study aimed to compare the efficacy of the pocket-creation method (PCM) with a traction device (TD) with that of conventional ESD for residual or recurrent colorectal lesions. METHODS: We retrospectively studied 72 patients with residual or recurrent colorectal lesions resected using ESD. Overall, 31 and 41 lesions were resected using PCM with TD and conventional ESD methods, respectively. We compared patient background and treatment outcomes between the PCM with TD and conventional ESD groups, respectively. The primary endpoints were en bloc resection and R0 resection rates. The secondary endpoints were the dissection speed and incidence of adverse events. RESULTS: En bloc resection was feasible in all cases with PCM with TD, but failed in 22% of cases of conventional ESD. The R0 resection rates for PCM with TD and conventional ESD were 97% and 66%, respectively. Dissection was significantly faster in the PCM with TD group (13.0 vs. 7.9 mm2/min). Perforation and postoperative bleeding were observed in one patient in each group. CONCLUSION: PCM with TD is an effective method for treating residual or recurrent colorectal lesions after incomplete resection.

Training program using a traction device improves trainees' learning curve of colorectal endoscopic submucosal dissection.

BACKGROUND: Colorectal endoscopic submucosal dissection (ESD) requires advanced endoscopic skill. For safer and more reliable ESD implementation, various traction devices have been developed in recent years. The purpose of this research was to evaluate whether an ESD training program using a traction device (TD) would contribute to the improvement of trainees' skill acquisition. METHODS: The differences in treatment outcomes and learning curves by the training program were compared before and after the introduction of TD (control group: January 2014 to March 2016; TD group: April 2016 to June 2018). RESULTS: A total of 316 patients were included in the analysis (TD group: 202 cases; control group: 114 cases). The number of cases required to achieve proficiency in ESD techniques was 10 in the TD group and 21 in the control group. Compared to the control group, the TD group had a significant advantage in ESD self-completion rate (73.8% vs. 58.8%), dissection speed (19.5 mm2/min vs. 15.9 mm2/min), en bloc resection rate (100% vs. 90%), and R0 resection rate (96% vs. 83%). CONCLUSIONS: The rate of colorectal ESD self-completion by trainees improved immediately after the start of the training program using a traction device compared to the conventional method, and the dissection speed tended to increase linearly with ESD experience. We believe that ESD training using a traction device will help ESD techniques to be performed safely and reliably among trainees.

Clinical utility of the pocket-creation method with a traction device for colorectal endoscopic submucosal dissection.

BACKGROUND: Colorectal endoscopic submucosal dissection (ESD) is technically demanding while ensuring safety, especially in cases with fibrosis and/or poor maneuverability. To overcome such difficulties, we developed a novel method called the pocket-creation method with a traction device (PCM with TD). We then evaluated the effectiveness and safety of PCM with TD in colorectal ESD compared to other conventional methods. METHODS: In total, 324 colorectal lesions treated with ESD from July 2018 to June 2019 were included. The following three treatment strategies were used: conventional ESD (CE), CE with TD, and PCM with TD. Patient backgrounds and treatment outcomes were retrospectively compared and analyzed. RESULTS: As ESD methods, CE, CE with TD, and PCM with TD account for 58% (187/324), 24% (78/324), and 18% (59/324), respectively. No significant difference was observed among the three groups in en bloc and R0 resection rates or adverse events. The rate of lesions with fibrosis and poor maneuverability was significantly higher in the PCM with TD group (CE group vs CE with TD group vs PCM with TD group: fibrosis, 24% vs 47% vs 64%, p < 0.001; poor maneuverability, 5.3% vs 13% vs 20%, p = 0.002). Dissection speed was significantly higher in the PCM with TD than in the CE with TD group (p = 0.003). CONCLUSIONS: PCM with TD can achieve a stable en bloc resection rate and R0 dissection rate without adverse events even in the hands of trainees, irrespective of the size and location of the lesion, presence of fibrosis, and under poor maneuverability conditions.

Intra-abdominal pressure during endoscopic full-thickness resection comparing manual and automatic control insufflation: a block-randomized porcine study.

BACKGROUND AND STUDY AIMS: An automatic carbon dioxide (CO2) insufflating system (SPACE) was developed to stabilize intra-lumenal pressure (ILP) during endoscopic interventions. This study investigated whether SPACE could improve the control and monitoring of extra-lumenal intra-abdominal pressure (IAP) after establishing a perforation during endoscopic full-thickness resection (EFTR) of the gastric wall in porcine models. MATERIALS AND METHODS: After first establishing the optimal preset pressure for gastric EFTR in four pigs, we compared IAP dynamics during EFTR between manual insufflation and SPACE using a block-randomized study (n = 10). IAP was percutaneously monitored and plotted on a timeline graph every 5 s. The maximal IAP and the area under the IAP curve exceeding 10 mmHg (AUC≥10 mmHg) were compared between groups, with the agreement between IAP and endolumenally monitored ILP also analyzed for animals in the SPACE group. RESULTS: In the first study, 8 mmHg was identified as the most preferable preset pressure after establishment of the perforation. In the randomized study, the mean maximal IAP in the SPACE group was significantly lower than that in the manual insufflation group (11.0 ± 2.0 mmHg vs. 17.0 ± 3.5 mmHg; P = 0.03). The mean AUC≥10 mmHg was also significantly smaller in the SPACE group. Bland-Altman analysis demonstrated agreement between IAP and ILP within a range of ± 1.0 mmHg. CONCLUSIONS: SPACE could be used to control and safely monitor IAP during gastric EFTR by measuring ILP during perforation of the gastric wall.

Colorectal endoscopic submucosal dissection can be efficiently performed by a trainee with use of a simple traction device and expert supervision.

Background and study aims Colorectal endoscopic submucosal dissection (ESD) is technically challenging owing to submucosal fibrosis and difficult endoscope manipulation. Therefore, various traction methods have been reported. We often use a simple looped nylon thread attached to a clip to assist with dissection. We assessed the feasibility of mentor-guided colorectal ESD using this traction device (TD). Patients and methods From December 2017 to March 2018, we retrospectively reviewed outcomes of 101 colorectal ESDs performed by two groups of endoscopists (A, 5 endoscopists with colorectal ESD experience of < 50 cases; B, 5 endoscopists with experience of > 300 cases). Group A was further divided into two subgroups that performed ESD with or without TD. Results No significant difference was observed in ESD completion rates (86.1 % [62/72] vs. 96.6 % [28/29]; odds ratio [OR], 0.22; 95 % confidence interval [CI], 0.005 - 1.71; P  = 0.17) or procedure times (52.0 min vs. 40.0 min; P  = 0.27) and adverse event rates between groups A and B. The rate of TD use was significantly higher in group A than in group B (44.4 % [32/72] vs. 20.7 % [6/29]; OR, 3.03; CI, 1.04 - 10.23; P  = 0.03). The completion rate was not different between the two subgroups of group A (with vs. without TD) (81.2 % [26/32] vs. 90.0 % [36/40]; OR, 0.49; CI, 0.09 - 2.29; P  = 0.32); however, the proportion of fibrosis cases was significantly higher in the TD-use group (46.8 % [15/32] vs. 22.5 % [9/40]; OR, 2.99; CI, 0.98 - 9.59; P  = 0.03). Conclusion Mentor-guided colorectal ESD using TD was performed efficiently, safely, and in a manner comparable to that of experts.

Short- and long-term outcomes of endoscopically treated superficial non-ampullary duodenal epithelial tumors.

BACKGROUND: It is widely recognized that endoscopic resection (ER) of superficial non-ampullary duodenal epithelial tumors (SNADETs) is technically challenging and may carry high risks of intraoperative and delayed bleeding and perforation. These adverse events could be more critical than those occurring in other levels of the gastrointestinal tract. Because of the low prevalence of the disease and the high risks of severe adverse events, the curability including short- and long-term outcomes have not been standardized yet. AIM: To investigate the curability including short- and long-term outcomes of ER for SNADETs in a large case series. METHODS: This retrospective study included cases that underwent ER for SNADETs at our university hospital between March 2004 and July 2017. Short-term outcomes of ER were measured based on en bloc and R0 resection rates as well as adverse events. Long-term outcomes included local recurrence detected on endoscopic surveillance and disease-specific mortality in patients followed up for ≥ 12 mo after ER. RESULTS: In the study, 131 patients with 147 SNADETs were analyzed. The 147 ERs consisted of 136 endoscopic mucosal resections (EMRs) (93%) and 11 endoscopic submucosal dissections (ESDs) (7%). The median tumor diameter was 10 mm. The pathology diagnosis was adenocarcinoma (56/147, 38%), high-grade intraepithelial neoplasia (44/147, 30%), or low-grade intraepithelial neoplasia (47/147, 32%). The R0 resection rate was 68% (93/136) in the EMR group and 73% (8/11) in the ESD group, respectively. Cap-assisted EMR (known as EMR-C) showed a higher rate of R0 resection compared to the conventional method of EMR using a snare (78% vs 62%, P = 0.06). No adverse event was observed in the EMR group, whereas delayed bleeding, intraoperative perforation, and delayed perforation in 3, 3, and 5 patients occurred in the ESD group, respectively. One patient with perforation required emergency surgery. In the 43 mo median follow-up period, local recurrence was found in four EMR cases and all cases were treated endoscopically. No patient died due to tumor recurrence. CONCLUSION: Our findings suggest that ER provides good long-term outcomes in the patients with SNADETs. EMR is likely to become the safe and reliable treatment for small SNADETs.

Closure of iatrogenic large mucosal and full-thickness defects of the stomach with endoscopic interrupted sutures in in vivo porcine models: are they durable enough?

BACKGROUND: In this study, we evaluated the technical feasibility of mucosal approximation of large ulcers via an endoscopic suturing system after endoscopic submucosal dissection (ESD), assessed the durability of these sutures, and compared this technique with serosal apposition of full-thickness gastric wall defects using the same device. METHODS: Post-ESD ulcers were closed with mucosal apposition in 7 pigs, and endoscopic full-thickness resection (EFTR) defects were closed with serosal apposition in 3 pigs. Pigs recovered for 1 week; they were then euthanized and necropsies were performed. RESULTS: Primary defect closure was achieved in 85.7% of the post-ESD closures and in 100% of the post-EFTR closures (p = 0.67). All pigs survived for 1 week. At necropsy, sutures had loosened in the post-ESD animals, although only minor deformity of the ulcer edges was observed in all repaired post-ESD ulcers. Meanwhile, all of the post-EFTR defect closures were sustained for 1 week. CONCLUSIONS: Primary closure of post-therapeutic defects can be accomplished using the device. Inverted serosal apposition provides a more durable and reliable repair than everted mucosal apposition.

A prospective randomized trial of lafutidine vs rabeprazole on post-ESD gastric ulcers.

AIM: To compare the effects of rabeprazole and lafutidine on post-endoscopic submucosal dissection (ESD) gastric ulcers. METHODS: Patients with gastric tumors indicated for ESD were prospectively studied. After ESD, all patients were treated with intravenous omeprazole for the first 3 d. Patients were then randomly assigned to oral lafutidine or rabeprazole. Ulcer size, ulcer size reduction rate, and ulcer stage were evaluated 4 wk later. Occurrence of complication was monitored throughout the 4-wk period. RESULTS: Sixty five patients were enrolled in the study, and 60 patients were subjected to the final analysis. In the lafutidine group (30 lesions in 29 patients), initial and 4-wk post-ESD ulcer sizes were 33.3 ± 9.2 and 10.5 ± 4.8 mm, respectively. In the rabeprazole group (34 lesions in 31 patients), the values were 34.7 ± 11.3 and 11.8 ± 6.7 mm, respectively. Ulcer size reduction rates in lafutidine and rabeprazole groups were 32.3% and 33.5%, respectively (P = 0.974). Ulcer stage 4 wk post-ESD did not differ significantly between the two groups (P = 0.868). Two cases in the rabeprazole group and no cases in the lafutidine group developed ulcer bleeding during the oral dose period, although the difference of bleeding rate between the two groups was not statistically significant (P = 0.157). CONCLUSION: Lafutidine and rabeprazole have equivalent therapeutic effects on post-ESD gastric ulcers.