Development and initial validation of an instrument for video-based assessment of technical skill in ERCP.

BACKGROUND AND AIMS: The accurate measurement of technical skill in ERCP is essential for endoscopic training, quality assurance, and coaching of this procedure. Hypothesizing that technical skill can be measured by analysis of ERCP videos, we aimed to develop and validate a video-based ERCP skill assessment tool. METHODS: Based on review of procedural videos, the task of ERCP was deconstructed into its basic components by an expert panel that developed an initial version of the Bethesda ERCP Skill Assessment Tool (BESAT). Subsequently, 2 modified Delphi panels and 3 validation exercises were conducted with the goal of iteratively refining the tool. Fully crossed generalizability studies investigated the contributions of assessors, ERCP performance, and technical elements to reliability. RESULTS: Twenty-nine technical elements were initially generated from task deconstruction. Ultimately, after iterative refinement, the tool comprised 6 technical elements and 11 subelements. The developmental process achieved consistent improvements in the performance characteristics of the tool with every iteration. For the most recent version of the tool, BESAT-v4, the generalizability coefficient (a reliability index) was .67. Most variance in BESAT scores (43.55%) was attributed to differences in endoscopists' skill, indicating that the tool can reliably differentiate between endoscopists based on video analysis. CONCLUSIONS: Video-based assessment of ERCP skill appears to be feasible with a novel instrument that demonstrates favorable validity evidence. Future steps include determining whether the tool can discriminate between endoscopists of varying experience levels and predict important outcomes in clinical practice.

Outcomes and quality of life assessment after per oral endoscopic myotomy (POEM) performed in the endoscopy unit with trainees.

BACKGROUND: Per oral endoscopic myotomy (POEM) has emerged as a promising option for the treatment of achalasia. This study assessed POEM training process, outcomes, and improvement in quality of life after POEM performed by an interventional endoscopist (mentor) with trainees. METHODS: We performed a retrospective review of data for patients who underwent POEM with involvement of trainees. Trainees were trained in performing mucosotomy, submucosal dissection, creating submucosal tunnel, identifying gastroesophageal junction, myotomy, and closure of mucosal incision in a step-by-step fashion. Trainees' performance on each step was evaluated by the mentor based on several key points in each step. The short form 36 (SF36) was obtained before and certain times after the primary POEM procedure was performed. RESULTS: Sixty-two patients, 26 males and 36 females with a mean age of 59 years, who underwent POEM were enrolled. A checklist included all related items for each step was established. All trainees obtained competence within 6 cases for each step. 61/62 (98.3%) patients had a significant improvement in the Eckardt's score post POEM: 9.3 ± 1.5 prior to POEM and 2.6 ± 1.2 after the POEM (P = 0.001) and a decrease in mean lower esophageal sphincter pressure (LES): pre- and post-procedure mean LES pressures were 28.5 ± 11.4 and 12.1 ± 4.5 mmHg, respectively (P = 0.001). The SF-36 questionnaire demonstrated a significant improvement in quality of life and comparable with those without trainees in other studies. CONCLUSION: This preliminary study showed for the first time that training for POEM can be performed in a step-by-step fashion, learning mucosal incision, submucosal dissection, myotomy, and mucosal incision closure from an expert interventional endoscopist without increasing adverse events. The checklist for each step could be used as an important guide in training POEM. The outcomes of POEM in this study were similar to those reported by others without trainees. Further multiple center studies are needed to verify this training process and to establish a formal training protocol.

Molecular analysis of cyst fluid aspiration in the diagnosis and risk assessment of cystic lesions of the pancreas.

Pancreatic cyst detection is increasing largely due to increasing use of cross-sectional imaging. The management of pancreatic cysts differs for true cysts, pseudocysts, mucinous cysts, nonmucinous cysts, and malignant lesions. Depending on the setting, diagnostic tests, such as cross-sectional imaging, endoscopic ultrasound, cyst fluid chemistry, and cytology, have moderate accuracy in characterizing the cyst subtype. Molecular analysis of cyst fluid aspirates has shown promise in preliminary studies and may require smaller fluid volumes than is needed for carcinoembryonic antigen level and cytology. This article reviews published studies in which molecular analysis was performed in the evaluation of pancreatic cysts. The molecular studies are compared with the conventional tests. Most studies have had moderate sample sizes (16-124) and have characterized a high proportion of patients with malignant cysts. Evaluation of molecular analysis as a diagnostic tool merits larger prospective trials with long-term follow-up of patients who are not sent to surgery. Larger cysts may meet size criteria for resection, and it is the smaller cysts for which molecular analysis may be of benefit if additional molecular testing results in a change in management.

Leaks and endoscopic assessment of break of integrity after NOTES gastrotomy: the LEAKING study, a prospective, randomized, controlled trial.

BACKGROUND: Gastric leak testing after natural orifice transluminal endoscopic surgery (NOTES) gastrotomy closure may help reduce the risk of leaks after transgastric procedures. OBJECTIVE: To develop a novel endoscopy-based system to determine the presence of a leak after NOTES gastrotomy and to compare this system prospectively with radiographic leak testing. DESIGN: Prospective, randomized, controlled trial. SETTING: Academic Medical Center laboratory. SUBJECTS: Fifty swine. INTERVENTION: During the pretrial phase, an endoscopic system for the measurement of intragastric pressure was developed. In the trial phase, swine with a NOTES gastrotomy were randomized to endoscopic versus radiographic leak testing. If a leak was demonstrated, the gastrotomy was reclosed by using a second-generation prototype T-anchor system. The primary outcome was leak detection after gastrotomy closure. The secondary outcome variables included necropsy findings, peritoneal fluid analysis, histologic examination, and clinical outcome. RESULTS: Fourteen swine were included in the pretrial phase and 36 in the randomized trial. Swine were survived for a mean of 9 days postoperatively. Endoscopic pressure monitoring demonstrated a reproducible change in intragastric pressure with insufflation; r = 0.735, P = .001 and r = 0.769, P < or = .000 for the total and maximum pressures, respectively. Post-peritoneoscopy, there was a detectable and significant decrease in the mean total and mean maximum pressures versus baseline (P = .006 and P = .009). There was no significant difference between the radiologic and endoscopic arms in leak detection rate (4/18 vs 3/18, respectively, P = .500). Clinical outcomes and mean weight gain were equivalent. There was 1 operative abdominal wall injury and no deaths. LIMITATIONS: Animal study. CONCLUSION: Endoscopic pressure monitoring was reproducible, demonstrated the presence of gastric leak, and was as reliable as contrast-based radiographic leak testing.