<b><i>Background:</i></b> Endoscopic submucosal dissection (ESD) is a widely accepted and minimally invasive treatment for early gastric cancer (EGC) without the risk of lymph node metastasis (LNM). However, undifferentiated-type EGC (UD-EGC) is considered to have a relatively high risk of LNM. Recently, the Japan Clinical Oncology Group conducted a nonrandomized confirmatory trial (JCOG1009/1010) to evaluate the efficacy and safety of ESD for UD-EGC. Herein, we review the results of JCOG1009/1010 and the possibility of further expanding the indications for ESD. <b><i>Summary:</i></b> JCOG1009/1010 showed excellent technical results and 5-year overall survival in patients with UD-EGC. Based on the results, ESD for UD-EGC (cT1a) of ≤2 cm without ulceration was technically feasible and acceptable for standard treatment instead of gastrectomy with lymph node dissection. A review of the EGC of mixed histological type (mixed EGC) suggested that the mixed EGC might have worse biological behavior than the pure histological type. In cases of intramucosal EGC with pure signet-ring cell carcinoma or presenting a double-layer structure, the risk of LNM might be relatively low. Thus, there is a possibility of further expanding the indications or curative evaluations. In the case of UD-EGC after noncurative resection, the data suggest that the eCura system may be applicable to UD-EGC; however, due to the small number of cases, further study is warranted. <b><i>Key Message:</i></b> This review summarizes the present knowledge regarding indications for UD-EGC and the possibility of further expanding them.
Objectives
Endoscopic submucosal dissection (ESD) has become popular, but complications such as postoperative bleeding remain an issue. Although some methods of closing a mucosal defect with a snare and clips have been reported to be effective and safe, the snare is not a dedicated device, and the procedure is difficult and time‐consuming. We aimed to find an alternative method for defect closure after ESD by developing a dedicated device.
Methods
We have improved five prototypes. The load on the stopper when starting to tighten and loosen a loop and the maximum load on the stopper and the movement distance of the thread when sliding the stopper were measured five times for each prototype. With the 5th prototype, we finalized the design and named it FLEXLOOP. Additionally, the material and shape of the outer tube were improved. Then, the usability of FLEXLOOP was evaluated in pigs. The operation time for closing mucosal defects with the snare or FLEXLOOP was measured five times.
Results
We made FLEXLOOP, which had a lower load when sliding and a higher load when loosening than the snare. The improvement of the outer tube significantly reduced the load on the sheath when sliding it. We confirmed the feasibility of mucosal defect closure with FLEXLOOP in pigs. The median operation time was 563 s (range 340–679 s) with the snare and 355 s (range 303–455 s) with FLEXLOOP (p = 0.047).
Conclusions
FLEXLOOP can be a promising option for defect closure after ESD.
Background: Endoscopy-associated pathogen transmission has been recognized as an important issue of safety. Inadequate decontamination procedures and equipment malfunction are two leading causes of post-endoscopic infection and contamination. The current guideline suggests manual cleaning, followed by highlevel disinfection(HLD) as standard reprocessing procedure. The FDA has highlighted the cross-contamination risk associated with valves(suction, air/water and biopsy valve) when used with flexible gastrointestinal endoscope accessory in 2018. Single-use valves are still in development, and the feasibility remains unclear due to cost-effectiveness. In this study, we evaluated the effectiveness of manual cleaning, and the feasibility of HLD followed by steam sterilization(SS) as a practical method in real-world for valve reprocessing to decrease contamination rate. Methods: All valves from the endoscopy were reprocessed by 3 steps. Manual cleaning was followed by HLD, and HLD was followed by SS. We performed manual cleaning in 2 situations, under and without supervision. We cultured the samples of valves from the endoscopy after each reprocessing step. The SS protocol was under 134 C-136 C and 31-32 pounds per square inch for 4 minutes. The samples for cultures were acquired from 1ml bottom layer fluid by using 40 ml sterile distilled water soaking valves, followed by vibration with a vibrating tester for 1 minutes and centrifugation under 3000rmp for 5 minutes. All samples were cultured under 35 C for 48 hours. Results: 22 sets of cultures were obtained(8 sets under real-time supervision and 14 sets without supervision when manual cleaning). The positive culture rate was 77% after manual cleaning(63% under supervision and 86% without supervision), 32% after HLD(including 9% of false negative cultures which became positive after SS, 13% under supervision and 43% without supervision) and 18% after SS(0% under supervision and 29% without supervision). The positive high-concern organisms culture rate was 59% after manual cleaning(25% under supervision and 79% without supervision), 14% after HLD(including 5% of false negative cultures which became positive after SS, 13% under supervision and 14% without supervision) and 5% after SS(0% under supervision and 7% without supervision). The major high-concern organisms were Pseudomonas, Klebsiella and Enterococcus species. The cost of SS was around 0.1 USD for 1 valve in Taiwan. Conclusion: Adequate and well-qualified manual cleaning plays a central role in decontamination procedures. However, it seems not reliable in terms of the consistency in real-word practice. HLD followed by SS is superior to HLD alone, and it could reduce 33% contamination rate in this situation. If adequate manual cleaning can be ensured, it is possible to erase all the contamination by HLD followed by SS.
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