Face and construct validity of a novel mechanical ERCP simulator

__Background__ and study aims Simulation-based training has become an important pillar in competence-based medicine. However, limited data are available on use of simulators in training for endoscopic retrograde cholangiopancreatography (ERCP). We aimed to determine the face and construct validity of the Boškoski-Costamagna mechanical ERCP Trainer, and to assess its didactic value, as judged by experts. Methods Participants were divided into four groups based on ERCP lifetime experience: novices, intermediate, experienced, and experts. Participants performed several standardized assignments on the simulator. Outcome parameters included times to complete the procedure, ability to cannulate both ducts, number of attempts to cannulate the common bile duct and pancreatic duct, number of inadvertent pancreatic duct cannulations, successful stent placement, and successful stone extraction. All experts filled out a questionnaire on the simulator’s realism and didactic value. Results Novices (n = 11) completed the total procedure in 21:09 (min:sec), intermediates (n = 5) in 10:58, experienced (n = 8) in 06:42 and experts (n = 22) in 06:05. Experts were significantly faster than novices (Kruskal-Wallis test P < 0.000). Experts rated the realism of the simulator 7.12 on a 10-point Likert scale. The simulator’s potential as a tool for training novices was rated 3.91 on a four-point Likert scale, and there was a high agreement among experts to include the simulator in the training of novice endoscopists (3.86 on a four-point Likert scale). Conclusions The novel Boškoski-Costamagna ERCP simulator demonstrates good face and construct validity. ERCP experts highly agree on the didactic value and added value of this simulator in the training curriculum for novice endoscopists

Screening for head and neck second primary tumors in patients with esophageal squamous cell cancer: A systematic review and meta-analysis

Background: Esophageal squamous cell carcinomas (ESCCs) are often accompanied by head and neck second primary tumors (HNSPTs). The prognosis of patients with an additional HNSPT is worse compared with patients with only ESCC. Therefore, early detection of HNSPTs may improve the overall outcome of patients with ESCC. The purpose of this study was to investigate the yield of endoscopic screening for HNSPTs in patients with primary ESCC. Methods: We conducted a systematic literature search of all available databases. Studies were included if ESCC patients were endoscopically screened for HNSPT. The primary outcome was the pooled prevalence of HNSPTs. Results: Twelve studies, all performed in Japan, were included in this systematic review with a total of 6483 patients. The pooled prevalence of HNSPTs was 6.7% (95% confidence interval: 4.9–8.4). The overall heterogeneity was high across the studies (I 2 ¼ 89.0%, p < 0.001). Most HNSPTs were low stage (85.3%) and located in the hypopharynx (60.3%). The proportion of synchronous (48.2%) and metachronous (51.8%) HNSPTs was comparable. Conclusion: Based on our results, HNSPT screening could be considered in patients with primary ESCC. All studies were performed in Japan; it is therefore not clear whether this consideration applies to the Western world

Face validity of a synthetic papilla designed for biliary sphincterotomy training

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is considered one of the most technically demanding endoscopic procedures. Still, limited data are available on simulators in ERCP training. Recently, the Boškoski-Costamagna ERCP Trainer was validated as a realistic training model by our study group. As an extension to this model, a novel synthetic papilla has been designed allowing to train biliary sphincterotomy. We aimed to determine the face validity of this synthetic papilla and its didactic value for training sphincterotomy. Methods Expert participants, each with more a than 2500 ERCPs lifetime experience, were invited to perform a biliary sphincterotomy and fill out a questionnaire on the realism of the procedure and the didactic value. Results A total of 40 ERCP experts were included, originating from 16 different countries. Experts’ opinion on realism of performing a biliary sphincterotomy was rated with a median of 7 on a 10-point Likert scale, resemblance of the performed maneuvers 8 and tactile feedback 7. When asked if the cutting was perceived as realistic, experts rated a 6 and the cutting result was rated 8. Th

Effectiveness of topical budesonide in preventing esophageal strictures after endoscopic resection of esophageal cancer

Background and study aims A disadvantage of endoscopic resection (ER) of early esophageal cancer (EC) is the high stricture rate after resection. A risk factor for stricture development is a mucosal defect after ER of ≥ 75 % of the esophageal circumference. Stricture rates up to 94 % have been reported in these patients. The aim of this stu

Endoscopic resection of advanced ampullary adenomas: a single-center 14-year retrospective cohort study

Background: Endoscopic ampullectomy has been recognized as a safe and reliable means to resect selective tumors of the ampulla of Vater and is associated with lower morbidity and mortality rates compared to surgical resection. Success rates range from 42 to 92%, with recurrences reported in up to 33%. Studies on endoscopic resection of advanced lesions such as those with intraductal extension of adenoma (IEA) and lateral spreading adenomas (LSA) are limited. We aimed to evaluate the technical success, complications, and recurrence of endoscopic resection of ampullary adenomas, including advanced lesions. Methods: All patients referred to the Erasmus Medical Center for endoscopic resection of an ampullary lesion were retrospectively identified between 2002 and 2016. Endoscopic success was defined as complete excision of the adenoma, irrespective of the number of attempts, in the absence of recurrence. Results: We included 87 patients with a median age of 65 years. Of these, 56 patients (64%) had an adenoma confined to the ampulla (ACA), 20 patients (23%) had an LSA, and 11 patients (13%) were treated for an IEA. The median lesion sizes were 24.6 mm, 41.4 mm, and 16.3 mm, respectively (P < 0.001). Complications occurred in 22 patients (25.3%), of which hemorrhage was most prevalent (12.6%), followed by perforation (8.1%). Complications were equally divided (P = 0.874). The median follow-up duration was 21.1 months (12–45.9) for ACA, 14.7 months (4.2–34.5) for LSA, and 5.8 months (3.7–22.0) for IEA (P = 0.051). Endoscopic resection was curative in 87.5% of patients with an ACA, 85% in patients with an LSA, and in only one patient with an IEA (P < 0.001). Recurrence occurred in 10 patients (11.5%) (P = 0.733). Conclusion: Endoscopic ampullectomy is safe and highly successful in selected patients with an adenoma with or without lateral spreading. Outcomes of endoscopic treatment adenomas with an intraductal extension are less favorable and in these cases surgery should be considered

A single-step sizing and radiofrequency ablation catheter for circumferential ablation of Barrett's esophagus: Results of a pilot study

Background: The 360 Express balloon catheter (360 Express) has the ability to self-adjust to the esophageal lumen, ensuring optimal tissue contact. Objective: The objective of this article is to evaluate the efficacy and safety of the 360 Express for radiofrequency ablation (RFA) treatment of Barrett's esophagus (BE). Methods: BE patients with low-grade dysplasia (LGD), high-grade dysplasia (HGD) or early cancer (EC) were included. Visible lesions were removed by endoscopic resection (ER) prior to RFA. RFA was performed with the 360 Express using the standard ablation regimen (12J/cm2–clean–12J/cm2). Primary outcome: BE regression percentage at three months. Secondary outcomes: procedure time, adverse events, complete eradication of dysplasia (CE-D) and intestinal metaplasia (CE-IM). Results: Thirty patients (median BE C4M6) were included. Eight patients underwent ER prior to RFA. Median BE regression: 90%. Median procedure time: 31 minutes. Adverse events (13%): laceration (n = 1); atrial fibrillation (n = 1); vomiting and dysphagia (n = 1); dysregulated diabetes (n = 1). After subsequent treatment CE-D and CE-IM was achieved in 97% and 87%, respectively. In 10% a stenosis developed during additional treatment requiring a median of one dilation. Conclusion: This study shows that circumferential RFA using the 360 Express may shorten procedure time, while maintaining efficacy compared to standard circumferential RFA

Propofol sedation without endotracheal intubation is safe for endoscopic submucosal dissection in the esophagus and stomach

Background: Endoscopic submucosal dissection (ESD) for early esophageal and stomach cancer is usually performed under general anesthesia. However, propofol sedation without endotracheal intubation has been suggested as a viable alternative. Objective: The objective of this study was to evaluate the safety of propofol sedation without endotracheal intubation during ESD in the upper gastrointestinal tract. Methods: We performed a retrospective cohort study of patients who underwent ESD for upper gastrointestinal tumors with propofol-remifentanil analgosedation in a tertiary referral center in the Netherlands between

Early detection of esophageal second primary tumors using Lugol chromoendoscopy in patients with head and neck cancer: A systematic review and meta-analysis

Background: Early detection of esophageal secondary primary tumors (SPTs) in head and neck squamous cell carcinoma (HNSCC) patients could increase patient survival. The purpose of this study was to determine the diagnostic yield of esophageal SPTs using Lugol chromoendoscopy. Methods: A systematic review of all available databases was performed to find all Lugol chromoendoscopy screening studies. Results: Fifteen studies with a total of 3386 patients were included. The average yield of esophageal-SPTs in patients with HNSCC was 15%. The prevalence was the highest for patients with an index hypopharyngeal (28%) or oropharyngeal (14%) tumor. The esophageal-SPTs were classified as high-grade dysplasia in 49% of the cases and as invasive carcinoma's in 51%. Conclusion: Our results show that 15% of the patients with HNSCC that underwent Lugol chromoendoscopy were diagnosed with an esophageal-SPT. Based on these results there is enough evidence to perform Lugol chromoendoscopy, especially in an Asian patient population

Do pathologists agree with each other on the histological assessment of pT1b oesophageal adenocarcinoma?

Background: In early (T1) oesophageal adenocarcinoma (OAC), the histological profile of an endoscopic resection specimen plays a pivotal role in the prediction of lymph node metastasis and the potential need for oesophagectomy with lymphadenectomy. Objective: To evaluate the inter-observer agreement of the histological assessment of submucosal (pT1b) OAC. Methods: Surgical and endoscopic resection specimens with pT1b OAC were independently reviewed by three gastrointestinal pathologists. Agreement was determined by intraclass correlation coefficient for continuous variables, and Fleiss' kappa (κ) for categorical variables. Bland–Altman plots of the submucosal invasion depth were made. Results: Eighty-five resection specimens with pT1b OAC were evaluated. The agreement was good for differentiation grade (κ=0.77, 95% confidence interval (CI) 0.68–0.87), excellent for lymphovascular invasion (κ=0.88, 95% CI 0.76–1.00) and moderate for submucosal invasion depth using the Paris and Pragmatic classifications (κ=0.60, 95% CI 0.49–0.72 and κ=0.42, 95% CI 0.33–0.51, respectively). Systematic mean differences between pathologists were detected for the measurement of submucosa