Self-Completion Method of Endoscopic Submucosal Dissection Using Endosaber without Any Other Device or Assistance: An ex vivo Porcine Model Study.

BACKGROUND: Endoscopic submucosal dissection (ESD) is a standard treatment for tumors of the gastrointestinal tract. We developed a self-completion method of ESD using Endosaber to eliminate the need for an additional device or human assistance during the procedure. The aim of this study was to evaluate the technical feasibility and outcomes of this method in an ex vivo porcine training model. METHODS: This was a pilot study, and the procedures were performed by 4 experts. Mock lesions measuring 15 mm in diameter were prepared at the posterior wall in the middle or lower esophagus obtained from domestic pigs. Each operator performed ESD on the mock lesions in 3 models. The primary outcome was ESD completion rate using the self-completion method. The secondary outcomes were procedure time, en bloc resection rate, perforation rate, and number of injections during the procedure. RESULTS: All 12 ESDs were completed using the self-completion method. The median procedure time (interquartile range) was 483.5 (399-619.3) s (median incision time: 240.4 [168.3-332.5] s; median dissection time: 222 [182.8-257] s). En bloc resection rate was 100%. No perforation was noted during any of the procedures. The median number of injections was 10.5 (9-14.3). The procedure time decreased significantly with increase in experience (p = 0.020). CONCLUSIONS: The self-completion ESD method using one Endosaber without any assistance achieved a 100% en bloc resection rate without any perforation. The need for an additional device or assistance was successfully eliminated. This method may prove to be a simple and cost-effective ESD procedure for lesions in humans.

Is a small-caliber or large-caliber endoscope more suitable for colonic self-expandable metallic stent placement? A randomized controlled study.

OBJECTIVES: The colonic self-expandable metallic stent (C-SEMS) with a 9-French (Fr) delivery system allows for a small-caliber endoscope (SCE) to be used to treat malignant colonic obstruction. Despite the lack of evidence, the SCE has become popular because it is considered easier to insert than the large-caliber endoscope (LCE). We aimed to determine whether the SCE is more suitable than the LCE for C-SEMS placement. METHODS: Between July 2018 and November 2019, 50 consecutive patients who were scheduled to undergo C-SEMS for colon obstruction were recruited in this study. Patients were randomized to the SCE or LCE group. The SCE and LCE were used with 9-Fr and 10-Fr delivery systems, respectively. The primary outcome was the total procedure time. Secondary outcomes were the technical success rate, complication rate, clinical success rate, insertion time, guidewire-passage time, stent-deployment time, and colonic obstruction-scoring-system score. RESULTS: Forty-five patients (SCE group, n = 22; LCE group, n = 23) were analyzed. The procedure time in the LCE group (median, 20.5 min) was significantly (p = 0.024) shorter than that in the SCE group (median, 25.1 min). The insertion time in the LCE group (median, 2.0 min) was significantly (p = 0.0049) shorter than that in the SCE group (median, 6.0 min). A sub-analysis of the procedure difficulties showed that the insertion time in the LCE group (median, 5.0 min) was significantly shorter than that in the SCE group (median, 8.5 min). CONCLUSION: Both LCE and SCE can be used for C-SEMS; however, LCE is more suitable than SCE as it achieved a faster and equally efficacious C-SEMS placement as that of SCE. CLINICAL TRIAL REGISTRATION NUMBER: University Hospital Medical Information Network Clinical Trials Registry (UMIN 32748).

How culture affects validity: understanding Japanese residents' sense-making of evaluating clinical teachers.

OBJECTIVES: Traditionally, evaluation is considered a measurement process that can be performed independently of the cultural context. However, more recently the importance of considering raters' sense-making, that is, the process by which raters assign meaning to their collective experiences, is being recognised. Thus far, the majority of the discussion on this topic has originated from Western perspectives. Little is known about the potential influence of an Asian culture on raters' sense-making. This study explored residents' sense-making associated with evaluating their clinical teachers within an Asian setting to better understand contextual dependency of validity. DESIGN: A qualitative study using constructivist grounded theory. SETTING: The Japanese Ministry of Health, Labour and Welfare has implemented a system to monitor the quality of clinical teaching within its 2-year postgraduate training programme. An evaluation instrument was developed specifically for the Japanese setting through which residents can evaluate their clinical teachers. PARTICIPANTS: 30 residents from 10 Japanese teaching hospitals with experience in evaluating their clinical teachers were sampled purposively and theoretically. METHODS: We conducted in-depth semistructured individual interviews. Sensitising concepts derived from Confucianism and principles of response process informed open, axial and selective coding. RESULTS: Two themes and four subthemes were constructed. Japanese residents emphasised the awareness of their relationship with their clinical teachers (1). This awareness was fuelled by their sense of hierarchy (1a) and being part of the collective society (1b). Residents described how the meaning of evaluation (2) was coloured by their perceived role as senior (2a) and their experienced responsibility for future generations (2b). CONCLUSIONS: Japanese residents' sense-making while evaluating their clinical teachers appears to be situated and affected by Japanese cultural values. These findings contribute to a better understanding of a culture's influence on residents' sense-making of evaluation instruments and the validity argument of evaluation.

The Efficacy and Safety of a Promising Single-Channel Endoscopic Closure Technique for Endoscopic Treatment-Related Artificial Ulcers: A Pilot Study.

BACKGROUND/AIMS: It is important to appropriately manage patients with procedure-related artificial mucosal ulcers or procedure-related complications. Many endoscopic closure techniques have been reported; however, they often require the use of special devices. We developed a single-channel endoscopic closure technique (SCCT) that can be performed with conventional devices. In the present study, we describe the technique and evaluate its efficacy. METHODS: Twenty-five consecutive patients who underwent endoscopic treatment and whose artificial ulcer was closed using the SCCT were enrolled in this study. The technical success rate, number of clips for closure, procedure time, complication rate on the day of the procedure, clinical success rates on days 1 and 5, and incidence of severe stenosis of the gastrointestinal (GI) tract at 2 months after the procedure were evaluated. RESULTS: The median ulcer diameter was 20 mm. The tumor locations were the stomach (n = 19), jejunum (n = 1), and colon (n = 5). The technical success rate was 100% (25/25), and the rate of incomplete closure was 0% (0/25). Eight clips were needed on average. The median procedure time was 18 min (range 5-49 min). The complication rate was 0% (25/25). The clinical success rates on days 1 and 5 were 100% (19/19) and 100% (9/9), respectively. No patients presented stenosis as a late complication at 2 months after the procedure (0/25). CONCLUSION: The SCCT could be applied in the treatment of artificial ulcers in several parts of the GI tract with a high clinical success rate and no complications. The SCCT appears to be a good option for closing artificial mucosal ulcers.