Cadaveric emergency cricothyrotomy training for non-surgeons using a bronchoscopy-enhanced curriculum.

BACKGROUND: Emergency cricothyrotomy training for non-surgeons is important as rare "cannot intubate or oxygenate events" may occur multiple times in a provider's career when surgical expertise is not immediately available. However, such training is highly variable and often infrequent, therefore, enhancing these experiences is important. RESEARCH QUESTION: Is bronchoscopy-enhanced cricothyrotomy training in cadavers feasible, and what are the potential benefits provided by this innovation for trainees? METHODS: This study was performed during implementation of a new program to train non-surgeon providers on cadaveric donors on our campus. Standard training with an instructional video and live coaching was enhanced by bronchoscopic visualization of the trachea allowing participants to review their technique after performing scalpel and Seldinger-technique procedures, and to review their colleagues' technique on live video. Feasibility was measured through assessing helpfulness for trainees, cost, setup time, quality of images, and operator needs. Footage from the bronchoscopy recordings was analyzed to assess puncture-to-tube time, safety errors, and evidence for a training effect within groups. Participants submitted pre- and post-session surveys assessing their levels of experience and gauging their confidence and anxiety with cricothyrotomies. RESULTS: The training program met feasibility criteria for low costs (<200 USD/donor), setup time (<30 minutes/donor), and operator needs (1/donor). Furthermore, all participants rated the cadaveric session as helpful. Participants demonstrated efficient technique, with a median puncture-to-tube time of 48.5 seconds. Bronchoscopy recordings from 24 analyzed videos revealed eight instances of sharp instruments puncturing the posterior tracheal wall (33% rate), and two instances of improper tube placement (8% rate). Sharp instruments reached potentially dangerous insertion depths beyond the midpoint of the anterior-posterior diameter of the trachea in 58.3% of videos. Bronchoscopic enhancement was rated as quite or extremely helpful for visualizing the trachea (83.3%) and to assess depth of instrumentation (91.7%). There was a significant average increase in confidence (64.4%, P<0.001) and average decrease in performance anxiety (-11.6%, P = 0.0328) after the session. A training effect was seem wherein the last trainee in each group had no posterior tracheal wall injuries. INTERPRETATION: Supplementing cadaveric emergent cricothyrotomy training programs with tracheal bronchoscopy is feasible, helpful to trainees, and meets prior documented times for efficient technique. Furthermore, it was successful in detecting technical errors that would have been missed in a standard training program. Bronchoscopic enhancement is a valuable addition to cricothyrotomy cadaveric training programs and may help avoid real-life complications.

The accuracy of hip fracture data entered into the national surgical quality improvement program (NSQIP) database.

PURPOSE: Internal validation studies of National Surgical Quality Improvement Program (NSQIP) registry data have reported potential inaccuracies. The purpose of this study was to determine the accuracy of hip fracture CPT codes and complications entered into NSQIP for a single participating center. METHODS: A retrospective study identified patients with a hip fracture CPT code from NSQIP data at a single institution over a two-year period. CPT codes included 27235 (percutaneous fixation of femoral neck fracture (Perc FNFX)), 27236 (open treatment of femoral neck fracture, internal fixation/prosthetic replacement (Open FNFX)), 27244 (open treatment of inter/peri/subtrochanteric femoral fracture with plate (Plate ITFX)), 27245 (treatment of inter/peri/subtrochanteric femoral fracture, with intramedullary implant (IMN ITFX)), and 27125 (hemiarthroplasty (HA)). The institutional medical record was reviewed to determine the accuracy of CPT code and 30-day complication data entered into the registry. RESULT: 12.8% (n = 20/156) of patients had an inaccurate CPT code. The proportion of inaccurate CPT codes varied significantly by procedure: Plate ITFX (76.9%), Open FNFX (13.8%), IMN ITFX (7.0%), and HA (0%) (p < 0.0001). A total of 82 complications were identified in 66 patients via the medical record. 43.9% (n = 36/82) of these complications were not documented in the NSQIP data. The proportion of missing complications varied significantly by type: renal (100%), UTI (53.8%), infection (50%), bleeding (30%), death (25%), respiratory (25%), cardiac (0%), stroke (0%), and VTE (0%) (p < 0.0001). CONCLUSION: Hip fracture CPT codes and 30-day complication data entered into the NSQIP registry were frequently inaccurate. Studies incorporating NSQIP data should acknowledge these potential limitations of the registry, and future research to validate NSQIP orthopedic data across procedures and institutions is necessary. LEVEL OF EVIDENCE: LEVEL III: Diagnostic study.

Threshold evaluation for optimal number of endoscopic treatment sessions to achieve complete eradication of Barrett's metaplasia.

BACKGROUND: Endoscopic eradication therapy (EET) is the standard of care for Barrett's esophagus (BE)-associated neoplasia. Previous data suggest the mean number of EET sessions required to achieve complete eradication of intestinal metaplasia (CE-IM) is 3. This study aimed to define the threshold of EET sessions required to achieve CE-IM. METHODS: The TREAT-BE Consortium is a multicenter outcomes cohort including prospectively enrolled patients with BE undergoing EET. All patients achieving CE-IM were included. Demographic, endoscopic, and histologic data were recorded at treatment onset along with treatment details and surveillance data. Kaplan-Meier analysis was performed to define a threshold of EET sessions, with 95 %CI, required to achieve CE-IM. A secondary analysis examined predictors of incomplete response to EET using multiple logistic regression and recurrence rates. RESULTS: 623 patients (mean age 65.2 [SD 11.6], 79.6 % male, 86.5 % Caucasian) achieved CE-IM in a mean of 2.9 (SD 1.7) EET sessions (median 2) and a median total observation period of 2.7 years (interquartile range 1.4-5.0). After three sessions, 73 % of patients achieved CE-IM (95 %CI 70 %-77 %). Age (odds ratio [OR] 1.25, 95 %CI 1.05-1.50) and length of BE (OR 1.24, 95 %CI 1.17-1.31) were significant predictors of incomplete response. CONCLUSION: The current study found that a threshold of three EET sessions would achieve CE-IM in the majority of patients. Alternative therapies and further diagnostic testing should be considered for patients who do not have significant response to EET after three sessions.

Endoscopic Ultrasound Placement of Preloaded Fiducial Markers Shortens Procedure Time Compared to Back-Loaded Markers.

BACKGROUND & AIMS: Fiducial markers are inert radiopaque gold or carbon markers implanted in or near pancreatic tumor to demarcate areas for image-guided radiation therapy. Endoscopic ultrasound (EUS) pre-loaded fiducial needles (PLNs) have been developed to circumvent technical issues associated with traditional back-loaded fiducials (BLNs). We performed a randomized controlled trial to compare procedure times in patients with pancreatic adenocarcinoma undergoing EUS-guided placement of BLNs vs PLNs. METHODS: In a prospective study, 44 patients with pancreatic adenocarcinoma referred for fiducial marker placement at 2 tertiary care centers were assigned to groups that received PLNs (n = 22) or BLNs (n = 22); each group had the same proportion of patients with tumors of different locations (head or neck vs body or tail).The procedure was standardized among all endoscopists and placement of a minimum of 3 markers inside the tumor was defined as technical success. The times for procedure and fiducial placement were recorded, total number of fiducial markers used documented, and grade of procedure difficulty ranked by passing the needle or deploying the fiducials. Other recorded variables included tumor characteristics, fluoroscopy use, and the number of fiducials clearly seen by EUS and fluoroscopy. The primary aim was to compare the duration of EUS-guided fiducial insertion of BLNs vs PLNs. RESULTS: The median placement time was significantly shorter in the PLN group (9 min) than the BLN group (16 min) (P < .001). However, the 44% reduction in time did not reach pre-specified levels (≥60%). Similar results were found after stratifying by tumor location. Deployment of BLNs was easier than deployment of PLNs (P = .03). There was no significant difference between groups in technical success, number of fiducials placed, EUS or fluoroscopic visualization, or adverse events. During simulation computed tomography and image-guided radiation therapy, there was no difference between groups in visualization of fiducials, migration rate, or accuracy of placement. CONCLUSIONS: In a randomized controlled trial of 44 patients with pancreatic adenocarcinoma, we found EUS-guided placement of PLNs to require less time and produce similar results compared with BLNs. Further refinements in PLN delivery system are needed to increase the ease of deployment. Clinicaltrials.gov no: NCT02332863.

A Survey of Expert Practice and Attitudes Regarding Advanced Imaging Modalities in Surveillance of Barrett's Esophagus.

BACKGROUND: Published guidelines do not address what the minimum incremental diagnostic yield (IDY) for detection of dysplasia/cancer is required over the standard Seattle protocol for an advanced imaging modality (AIM) to be implemented in routine surveillance of Barrett's esophagus (BE) patients. We aimed to report expert practice patterns and attitudes, specifically addressing the minimum IDY in the use of AIMs in BE surveillance. METHODS: An international group of BE experts completed an anonymous electronic survey of domains relevant to surveillance practice patterns and use of AIMs. The evaluated AIMs were conventional chromoendoscopy (CC), virtual chromoendoscopy (VC), volumetric laser endomicroscopy (VLE), confocal laser endomicroscopy (CLE), and wide-area transepithelial sampling (WATS3D). Responses were recorded using five-point balanced Likert items and analyzed as continuous variables. RESULTS: The survey response rate was 84% (61/73)-41 US and 20 non-US. Experts were most comfortable with and routinely use VC and CC, and least comfortable with and rarely use VLE, CLE, and WATS3D. Experts rated data from randomized controlled trials (1.4 ± 0.9) and guidelines (2.6 ± 1.2) as the two most influential factors for implementing AIMs in clinical practice. The minimum IDY of AIMs over standard biopsies to be considered of clinical benefit was lowest for VC (15%, IQR 10-29%) and highest for VLE (30%, IQR 20-50%). Compared to US experts, non-US experts reported higher use of CC for BE surveillance (p < 0.001). CONCLUSION: These results should inform benchmarks that need to be met for guidelines to recommend the routine use of AIMs in the surveillance of BE patients.

A Prospective Multicenter Study Evaluating Learning Curves and Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography Among Advanced Endoscopy Trainees: The Rapid Assessment of Trainee Endoscopy Skills Study.

BACKGROUND & AIMS: On the basis of the Next Accreditation System, trainee assessment should occur on a continuous basis with individualized feedback. We aimed to validate endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) learning curves among advanced endoscopy trainees (AETs) by using a large national sample of training programs and to develop a centralized database that allows assessment of performance in relation to peers. METHODS: ASGE recognized training programs were invited to participate, and AETs were graded on ERCP and EUS exams by using a validated competency assessment tool that assesses technical and cognitive competence in a continuous fashion. Grading for each skill was done by using a 4-point scoring system, and a comprehensive data collection and reporting system was built to create learning curves by using cumulative sum analysis. Individual results and benchmarking to peers were shared with AETs and trainers quarterly. RESULTS: Of the 62 programs invited, 20 programs and 22 AETs participated in this study. At the end of training, median number of EUS and ERCP performed/AET was 300 (range, 155-650) and 350 (125-500), respectively. Overall, 3786 exams were graded (EUS, 1137; ERCP-biliary, 2280; ERCP-pancreatic, 369). Learning curves for individual end points and overall technical/cognitive aspects in EUS and ERCP demonstrated substantial variability and were successfully shared with all programs. The majority of trainees achieved overall technical (EUS, 82%; ERCP, 60%) and cognitive (EUS, 76%; ERCP, 100%) competence at conclusion of training. CONCLUSIONS: These results demonstrate the feasibility of establishing a centralized database to report individualized learning curves and confirm the substantial variability in time to achieve competence among AETs in EUS and ERCP. ClinicalTrials.gov: NCT02509416.

Recurrence of intestinal metaplasia and early neoplasia after endoscopic eradication therapy for Barrett's esophagus: a systematic review and meta-analysis.

BACKGROUND: Conflicting data exist with regard to recurrence rates of intestinal metaplasia (IM) and dysplasia after achieving complete eradication of intestinal metaplasia (CE-IM) in Barrett's esophagus (BE) patients. AIM: (i) To determine the incidence of recurrent IM and dysplasia achieving CE-IM and (ii) to compare recurrence rates between treatment modalities [radiofrequency ablation (RFA) with or without endoscopic mucosal resection (EMR) vs stepwise complete EMR (SRER)]. METHODS: A systematic search was performed for studies reporting on outcomes and estimates of recurrence rates after achieving CE-IM. Pooled incidence [per 100-patient-years (PY)] and risk ratios with 95 %CI were obtained. Heterogeneity was measured using the I2 statistic. Subgroup analyses, decided a priori, were performed to explore heterogeneity in results. RESULTS: A total of 39 studies were identified (25-RFA, 13-SRER, and 2 combined). The pooled incidence of any recurrence was 7.5 (95 %CI 6.1 - 9.0)/100 PY with a pooled incidence of IM recurrence rate of 4.8 (95 %CI 3.8 - 5.9)/100 PY, and dysplasia recurrence rate of 2.0 (95 %CI 1.5 - 2.5)/100 PY. Compared to the SRER group, the RFA group had significantly higher overall [8.6 (6.7 - 10.5)/100 PY vs. 5.1 (3.1 - 7)/100 PY, P  = 0.01] and IM recurrence rates [5.8 (4.3 - 7.3)/100 PY vs. 3.1 (1.7 - 4)/100 PY, P  < 0.01] with no difference in recurrence rates of dysplasia. Significant heterogeneity between studies was identified. The majority of recurrences were amenable to repeat endoscopic eradication therapy (EET). CONCLUSION: The results of this study demonstrate that the incidence rates of overall, IM, and dysplasia recurrence rates post-EET are not inconsiderable and reinforce the importance of close surveillance after achieving CE-IM.

Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound-Guided Fine-Needle Aspiration.

BACKGROUND & AIMS: It is not clear exactly how many passes are required to determine whether pancreatic masses are malignant using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). We aimed to define the per-pass diagnostic yield of EUS-FNA for establishing the malignancy of a pancreatic mass, and identify factors associated with detection of malignancies. METHODS: In a prospective study, 239 patients with solid pancreatic masses were randomly assigned to groups that underwent EUS-FNA, with the number of passes determined by an on-site cytopathology evaluation or set at 7 passes, at 3 tertiary referral centers. A final diagnosis of pancreatic malignancy was made based on findings from cytology, surgery, or a follow-up evaluation at least 1 year after EUS-FNA. The cumulative sensitivity of detection of malignancy by EUS-FNA was calculated after each pass; in the primary analysis, lesions categorized as malignant or suspicious were considered as positive findings. RESULTS: Pancreatic malignancies were found in 202 patients (84.5% of the study population). EUS-FNA detected malignancies with 96% sensitivity (95% confidence interval [CI], 92%-98%); 4 passes of EUS-FNA detected malignancies with 92% sensitivity (95% CI, 87%-95%). Tumor size greater than 2 cm was the only variable associated with positive results from cytology analysis (odds ratio, 7.8; 95% CI, 1.9-31.6). In masses larger than 2 cm, 4 passes of EUS-FNA detected malignancies with 93% sensitivity (95% CI, 89%-96%) and in masses ≤2 cm, 6 passes was associated with 82% sensitivity (95% CI, 61%-93%). Sensitivity of detection did not increase with increasing number of passes. CONCLUSIONS: In a prospective study, we found 4 passes of EUS-FNA to be sufficient to detect malignant pancreatic masses; increasing the number of passes did not increase the sensitivity of detection. Tumor size greater than 2 cm was associated with malignancy, and a greater number of passes may be required to evaluate masses 2 cm or less. ClinicalTrials.gov number, NCT01386931.