Corrigendum: Adherence to European society of gastrointestinal endoscopy quality performance measures for upper and lower gastrointestinal endoscopy: a nationwide survey from the Italian society of digestive endoscopy.

[This corrects the article DOI: 10.3389/fmed.2022.868449.].

A New Step-Up Dual Endoscopic Approach for Large-Size Infected Pancreatic Necrosis: Percutaneous Endoscopic Necrosectomy Followed by Transluminal Endoscopic Drainage/Necrosectomy.

BACKGROUND: Acute pancreatitis in 10% to 20% of cases can be associated with necrosis of the pancreatic gland, peripancreatic tissue, or both. We report a case series of a new endoscopic approach to treat infected pancreatic necrosis (IPN). PATIENTS AND METHODS: Consecutive patients with IPN, extending from the perigastric area up to the paracolic gutters or into the pelvis, were prospectively studied from January 2017 to June 2022. The treatment protocol was radiologic percutaneous drainage as the first step, followed by fully covered metal stent placement (FC-SEMS) in the track of the catheter. Percutaneous endoscopic necrosectomy (PEN) was performed 2 to 4 days later using a flexible endoscope through the percutaneous tract. About 2 to 4 weeks later, when a matured sac was visible, EUS-guided endoscopic transluminal drainage (ETD) with lumen-apposing metal stents (LAMS) was performed. Control of sepsis with resolution of collection(s) was the primary outcome measure. RESULTS: We included 18 patients, males in 50% of cases with age 60±12 years old. Most frequent cause of pancreatitis was biliary (7 cases) followed by alcoholic in 6 cases; in 3 cases pancreatitis was caused by hyperlipemia and in 2 cases was idiopathic. Mean size of WON was 18±2 cm. For PEN, SEMSs used were esophageal FC-SEMS. LAMS used for ETD were Hot Axios, Hot Spaxus and Nagistent. Mean time of endoscopic intervention for PEN and ETD was 18±3 and 37±4 days, respectively. In 5 cases adverse events occurred: 3 cases of overinflations resolved with introduction of Verres needles in abdomen. In 2 cases postprocedural GI bleeding required endoscopic intervention. In all cases control of sepsis was reached together with resolution of collections. No cases of deaths were observed. CONCLUSIONS: Step-up percutaneous and transluminal endoscopic necrosectomy therapy is an effective strategy for large-size IPN with combined central and peripheral necrosis.

SIED-GISCOR recommendations for colonoscopy in screening programs: Part I - Diagnostic.

The implementation of FIT programs reduces incidence and mortality from CRC in the screened subjects. The ultimate efficacy for CRC morbidity and mortality prevention in a FIT program depends on the colonoscopy in FIT+ subjects that has the task of detecting and removing these advanced lesions. Recently, there has been growing evidence on factors that influence the quality of colonoscopy specifically withing organized FIT programs, prompting to dedicated interventions in order to maximize the benefit/harm ratio of post-FIT colonoscopy. This document focuses on the diagnostic phase of colonoscopy, providing indications on how to standardise colonoscopy in FIT+ subjects, regarding timing of examination, management of antithrombotic therapy, bowel preparation, competence and sedation.

Repeated endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions after previous nondiagnostic or inconclusive sampling.

OBJECTIVES: Repeated endoscopic ultrasound (EUS)-guided tissue acquisition represents the standard practice for solid pancreatic lesions after previous nondiagnostic or inconclusive results. Since data are lacking, we aimed to evaluate the diagnostic performance of repeated EUS fine-needle biopsy (rEUS-FNB) in this setting. The primary outcome was diagnostic accuracy; sample adequacy, sensitivity, specificity, and safety were secondary outcomes. METHODS: Consecutive patients undergoing rEUS-FNB for solid pancreatic lesions at 23 Italian centers from 2019 to 2021 were retrieved. Pathology on the surgical specimen, malignant histology together with ≥6-month follow-up, and benign pathology together with ≥12-month follow-up were adopted as gold standards. RESULTS: Among 462 patients, 56.5% were male, with a median age of 68 (59-75) years, malignancy prevalence 77.0%. Tumor size was 26 (20-35) mm. Second-generation FNB needles were used in 89.6% cases. Diagnostic accuracy, sensitivity, and specificity of rEUS-FNB were 89.2%, 91.4%, and 81.7%, respectively (19 false-negative and 12 false-positive results). On multivariate analysis, rEUS-FNB performed at high-volume centers (odds ratio [OR] 2.12; 95% confidence interval [CI] 1.10-3.17; P = 0.03) and tumor size (OR 1.03; 95% CI 1.00-1.06; P = 0.05) were independently related to diagnostic accuracy. Sample adequacy was 94.2%. Use of second-generation FNB needles (OR 5.42; 95% CI 2.30-12.77; P < 0.001) and tumor size >23 mm (OR 3.04; 95% CI 1.31-7.06; P = 0.009) were independently related to sample adequacy. CONCLUSION: Repeated EUS-FNB allowed optimal diagnostic performance after nondiagnostic or inconclusive results. Patients' referral to high-volume centers improved diagnostic accuracy. The use of second-generation FNB needles significantly improved sample adequacy over standard EUS-FNB needles.

Acute left-sided malignant colonic obstruction: Is there a role for endoscopic stenting?

The therapy of left-sided malignant colonic obstruction continues to be one of the largest problems in clinical practice. Numerous studies on colonic stenting for neoplastic colonic obstruction have been reported in the last decades. Thereby the role of self-expandable metal stents (SEMS) in the treatment of malignant colonic obstruction has become better defined. However, numerous prospective and retrospective investigations have highlighted serious concerns about a possible worse outcome after endoscopic colorectal stenting as a bridge to surgery, particularly in case of perforation. This review analyzes the most recent evidence in order to highlight pros and cons of SEMS placement in left-sided malignant colonic obstruction.

Exposed endoscopic full-thickness resection and overstitch suture after incomplete nonexposed endoscopic full-thickness resection.

Video 1Endoscopic resection and suture of neoplastic recurrence after the use of endoscopic full-thickness resection devices for invasive rectal adenocarcinoma.

Asparaginase-associated Pancreatitis Complicated by Pancreatic Fluid Collection Treated with Endoscopic Cistogastrostomy in Pediatric Acute Lymphoblastic Leukemia: A Case Report and Systematic Review of the Literature.

Asparaginase-associated pancreatitis complicates 2-10% of patients treated for acute lymphoblastic leukemia, causing morbidity and discontinuation of asparaginase administration. Among acute complications, pancreatic fluid collections can be managed conservatively, but intervention is indicated when associated with persistent insulin therapy need and recurrent abdominal pain. Endoscopic treatment has become the standard approach in adult patients, with increasing favorable evidence in children. This work compares the characteristics of a pediatric oncology patient treated at our institution with reported literature experiences, showing feasibility, safety and effectiveness of endoscopic approach.

Post-trans-arterial chemoembolization hepatic necrosis and biliary stenosis: Clinical charateristics and endoscopic approach.

Liver cancer is the fifth most common tumor and the second highest death-related cancer in the world. Hepatocarcinoma (HCC) represents 90% of liver cancers. According to the Barcelona Clinic Liver Cancer group, different treatment options could be offered to patients in consideration of tumor burden, liver function, patient performance status and biochemical marker serum concentration such as alpha-fetoprotein. Trans-arterial chemoembolization (TACE) is the treatment of choice in patients with diagnosis of unresectable HCC not eligible for liver transplantation, and preserved arterial supply. TACE is known to be safe and its complications are generally mild such as post-TACE syndrome, a self-resolving adverse event that occurs in about 90% of patients after the procedure. However, albeit rarely, more severe adverse events such as biloma, sepsis, hepatic failure, chemoagents induced toxicities, and post-TACE liver necrosis can occur. A prompt diagnosis of these clinical conditions is fundamental to prevent further complications. As a result, biliary stenosis could be a rare post-TACE necrosis complication and can be difficult to manage. Complications from untreated biliary strictures include recurring infections, jaundice, chronic cholestasis, and secondary biliary cirrhosis.

Accuracy and agreement of a large panel of endosonographers for endomicroscopy-guided virtual biopsy of pancreatic cystic lesions.

BACKGROUND: Although emerging data evidences that EUS-guided needle-based confocal laser endomicroscopy (nCLE) accurately diagnoses pancreatic cystic lesions (PCLs), there are a lack of interobserver agreement (IOA) studies utilizing reference histopathological diagnosis and for specific PCL subtypes. Hence, we sought to assess the IOA, intra-observer reliability (IOR), and diagnostic performance of EUS-nCLE using a large cohort of patients with histopathological diagnosis amongst a broad panel of international observers. METHODS: EUS-nCLE videos (n = 76) of subjects with PCLs [intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), serous cystadenoma (SCA), pseudocyst, and cystic-neuroendocrine tumors/solid pseudopapillary neoplasm (cystic-NET/SPN)], simulating clinical prevalence rates were obtained from 3 prospective studies. An international panel of 13 endosonographers with nCLE experience, blinded to all PCL data, evaluated the video library twice with a two-week washout for PCL differentiation (mucinous vs. non-mucinous) and subtype diagnosis. RESULTS: The IOA (κ = 0.82, 95% CI 0.77-0.87) and IOR (κ = 0.82, 95% CI 0.78-0.85) were "almost perfect" to differentiate mucinous vs. non-mucinous PCLs. For PCL subtype, IOA was highest for SCA (almost perfect; κ = 0.85), followed by IPMN (substantial, κ = 0.72), and cystic-NET/SPN (substantial, κ = 0.73). The IOA was moderate for MCN (κ = 0.47), and pseudocyst (κ = 0.57). Compared to histopathology, observers differentiated mucinous vs. non-mucinous PCLs with high accuracy (94.8%, 95% CI 93.3-96.1). For detecting specific PCLs subtypes, EUS-nCLE was highly accurate in diagnosing non-mucinous cysts (SCA: 98%; cystic-NET/SPN: 96%; pseudocyst: 96%) and slightly less accurate for mucinous lesions (IPMN: 86%; MCN: 84%). CONCLUSION: Diagnosis of PCLs by EUS-nCLE guided virtual biopsy is very accurate and reliable for the most prevalent pancreatic cysts in clinical practice.

Digital single-operator cholangioscopy in diagnostic and therapeutic bilio-pancreatic diseases: A prospective, multicenter study.

BACKGROUND AND AIM: Digital single-operator cholangioscopy (D-SOC) is an endoscopic procedure that is increasingly used for the management of bilio-pancreatic diseases. We aimed to investigate the efficacy and safety of D-SOC for diagnostic and therapeutic indications. METHODS: This is a multicenter, prospective study(January 2016-June 2019) across eighteen tertiary centers. The primary outcome was procedural success of D-SOC. Secondary outcomes were: D-SOC visual assessment and diagnostic yield of SpyBite biopsy in cases of biliary strictures, stone clearance rate in cases of difficult biliary stones, rate of adverse events(AEs) for all indications. RESULTS: D-SOC was performed in 369 patients (201(54,5%) diagnostic and 168(45,5%)therapeutic). Overall, procedural success rate was achieved in 360(97,6%) patients. The sensitivity, specificity, PPV, NPV and accuracy in biliary strictures were: 88,5%, 77,3%, 83,3%, 84,1% and 83,6% for D-SOC visual impression; 80,2%, 92,6%, 95,1%, 72,5% and 84,7% for the SpyBite biopsy, respectively. For difficult biliary stones, complete duct clearance was obtained in 92,1% patients (82,1% in a single session). Overall, AEs occurred in 37(10%) cases.The grade of AEs was mild or moderate for all cases, except one which was fatal. CONCLUSION: D-SOC is effective for diagnostic and therapeutic indications.Most of the AEs were minor and managed conservatively, even though a fatal event has happened that is not negligible and should be considered before using D-SOC.

Adherence to European Society of Gastrointestinal Endoscopy Quality Performance Measures for Upper and Lower Gastrointestinal Endoscopy: A Nationwide Survey From the Italian Society of Digestive Endoscopy.

Background: The quality of gastrointestinal (GI) endoscopy has been recently identified as a major priority being associated with many outcomes and patient's experience. Objective: To assess adherence of endoscopists to the European Society of Gastrointestinal Endoscopy (ESGE) quality performance measures for upper and lower GI endoscopy in Italy. Methods: All endoscopist members of the Italian Society of Digestive Endoscopy (SIED) were invited from October 2018 to December 2018 to participate to a self-administered questionnaire-based survey. The questionnaire included questions on demographics and professional characteristics, and the recent ESGE quality performance measures for upper and lower GI endoscopy. Results: A total of 392 endoscopists participated in the study. Only a minority (18.2%) of participants recorded the duration of esophagogastroduodenoscopy (EGD) and 51% provided accurate photo documentation in the minimum standard of 90% of cases. Almost all endoscopists correctly used Prague and Los Angeles classifications (87.8% and 98.2%, respectively), as well as Seattle and Management of precancerous conditions and lesions in the stomach (MAPS) biopsy protocols (86.5% and 91.4%, respectively). However, only 52.8% of participants monitored complications after therapeutic EGD, and 40.8% recorded patients with a diagnosis of Barrett's esophagus (BE). With regard to colonoscopy, almost all endoscopists (93.9%) used the Boston Bowel Preparation Scale for measuring bowel preparation quality and reported a cecal intubation rate ≥90%. However, about a quarter (26.2%) of participants reported an adenoma detection rate of <25%, only 52.8% applied an appropriate polypectomy technique, 48% monitored complications after the procedure, and 12.4% measured patient's experience. Conclusion: The adherence of endoscopists to ESGE performance measures for GI endoscopy is sub-optimal in Italy. There is a need to disseminate and implement performance measures and endorse educational and scientific interventions on the quality of endoscopy.

Migration rate using fully covered metal stent in anastomotic strictures after liver transplantation: Results from the BASALT study group.

BACKGROUND AND STUDY AIM: The traditional endoscopic therapy of anastomotic strictures (AS) after orthotopic liver transplantation (OLT) is multiple ERCPs with the insertion of an increasing number of plastic stents side-by-side. Fully covered self-expanding metal stents (cSEMS) could be a valuable option to decrease the number of procedures needed or non-responders to plastic stents. This study aims to retrospectively analyse the results of AS endoscopic treatment by cSEMS and to identify any factors associated with its success. PATIENTS AND METHODS: Ninety-one patients (mean age 55.9 ± 7.6 SD; 73 males) from nine Italian transplantation centres, had a cSEMS positioned for post-OLT-AS between 2007 and 2017. Forty-nine (54%) patients were treated with cSEMS as a second-line treatment. RESULTS: All the procedures were successfully performed without immediate complications. After ERCP, adverse events occurred in 11% of cases (2 moderate pancreatitis and 8 cholangitis). In 49 patients (54%), cSEMSs migrated. After cSEMS removal, 46 patients (51%) needed further endoscopic (45 patients) or radiological (1 patient) treatments to solve the AS. Lastly, seven patients underwent surgery. Multivariable stepwise logistic regression showed that cSEMS migration was the only factor associated with further treatments (OR 2.6, 95% CI 1.0-6.6; p value 0.03); cSEMS implantation before 12 months from OLT was associated with stent migration (OR 5.2, 95% CI 1.7-16.0; p value 0.004). CONCLUSIONS: cSEMS appears to be a safe tool to treat AS. cSEMS migration is the main limitation to its routinary implantation and needs to be prevented, probably with the use of new generation anti-migration stents.

Is the use of fully covered metal stents effective in the treatment of difficult lithiasis of the common bile duct?

BACKGROUND: The management of difficult lithiasis of common bile duct (CBD) often requires a multimodal approach. Fully Covered Metal Stents (FCSEMS) could fragment the stones, dilate strictures of the CBD and progressively enlarge the papillary orifice. The aim of the study was to evaluate the efficacy of FCSEMS in the treatment of difficult lithiasis of CBD. METHODS: All consecutive cases of difficult lithiasis of CBD after an attempt of clearance with complete sphincterotomy were retrospectively considered from 2009 to 2019. Intrahepatic lithiasis cases were excluded. Multivariable analysis (stepwise logistic regression if p value < 0.1 at univariable analysis) was made to understand factors associated with efficacy of FCSEMS in difficult lithiasis of CBD. RESULTS: 163 cases of difficult lithiasis over 1516 cases of lithiasis of CBD (incidence of 11%) were considered. Among eligible patients, 96 (mean age 78 ± 11.9 years, 43% males) placed a FCSEMS during the first ERCP. Mean diameter of stone was 17.5 ± 5.5 mm. An attempt of dilation during the same procedure was made in 18% cases. After removal of the stent, 52 (54%) patients had complete clearance of CBD at cholangiography. The rest of patients (44), subsequently underwent multimodal treatment (final success of 95%). After logistic regression, variables positively associated with clearance of CBD were sex male (OR 3.5) and stent permanence ≥ 30 days (OR 3.2). Diameter of the stone ≥ 2 cm was associated with failure (OR 0.2). 7 post-ERCP pancreatitis, 6 post-sphincterotomy bleeding and 3 cholangitis occurred. CONCLUSIONS: FCSEMS are useful in the approach of difficult lithiasis of CBD with no significant adverse events associated.

Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures: The Monaco Classification.

BACKGROUND: Visual characteristics seen during digital single-operator cholangioscopy (DSOC) have not been validated. The aim of this 2-phase study was to define terminology by consensus for the visual diagnosis of biliary lesions to develop a model for optimization of the diagnostic performance of DSOC. MATERIALS AND METHODS: In phase 1 (criteria identification), video-cholangioscopy clips were reviewed by 12 expert biliary endoscopists, who were blinded to the final diagnosis. Visual criteria were consolidated into the following categories: (1) stricture, (2) lesion, (3) mucosal features, (4) papillary projections, (5) ulceration, (6) abnormal vessels, (7) scarring, (8) pronounced pit pattern.During the second phase (validation), 14 expert endoscopists reviewed DSOC (SpyGlass DS, Boston Scientific) clips using the 8 criteria to assess interobserver agreement (IOA) rate. RESULTS: In phase 1, consensus for visual findings were categorized into 8 criteria titled the "Monaco Classification." The frequency of criteria were: (1) presence of stricture-75%, (2) presence of lesion type-55%, (3) mucosal features-55%, (4) papillary projections-45%, (5) ulceration-42.5%, (6) abnormal vessels-10%, (7) scarring-40%, and (8) pronounced pit pattern-10%. The accuracy on final diagnosis based on visual impression alone was 70%.In phase 2, the IOA rate using Monaco Classification criteria ranged from slight to fair. The presumptive diagnosis IOA was fair (κ=0.31, SE=0.02), and overall diagnostic accuracy was 70%. CONCLUSIONS: The Monaco classification identifies 8 visual criteria for biliary lesions on single-operator digital cholangioscopy. Using the criteria, the IOA and diagnostic accuracy rate of DSOC is improved compared with prior studies.

Digital Cholangioscopic Interpretation: When North Meets the South.

BACKGROUND: Digital single-operator cholangioscopy (DSOC) (SpyGlass DS™, Boston Scientific, MA, USA) allows for high-definition imaging of the biliary tree. The superior visualization has led to the development of two different sets of criteria to evaluate and classify indeterminate biliary strictures: the Monaco criteria and the criteria in Carlos Robles-Medranda's publication (CRM). Our objective was to assess the interrater agreement (IA) of DSOC interpretation for indeterminate biliary strictures using the two newly published criteria. METHODS: Forty de-identified DSOC video recordings were sent to 15 interventional endoscopists with experience in cholangioscopy. They were asked to score the videos based on the presence of Monaco Classification criteria: stricture, lesion, mucosal changes, papillary projections, ulceration, white linear bands or rings, and vessels. Next, they scored the videos using CRM criteria: villous pattern, polypoid pattern, inflammatory pattern, flat pattern, ulcerate pattern and honeycomb pattern. The endoscopists then diagnosed the recordings as neoplastic or non-neoplastic based on the criteria. Intraclass correlation (ICC) analysis was done to evaluate interrater agreement for both criteria set and final diagnosis. RESULTS: Recordings of 26 malignant lesions and 14 benign lesions were scored. The IA using both the Monaco criteria and CRM criteria ranged from poor to excellent (range 0.1-0.76) and (range 0.1-0.62), respectively. Within the Monaco criteria, IA was excellent for lesion (0.75) and fingerlike papillary projections (0.74); good for tortuous vessels (0.7), mucosal features (0.62), uniform papillary projections (0.53), and ulceration (0.58); and fair for white linear bands (0.4). Within the CRM criteria, the IA was good for villous pattern (0.62), flat pattern (0.62), and honeycomb pattern; fair for ulcerated pattern (0.56), polypoid pattern (0.52) and inflammatory pattern (0.54). The diagnostic IA using Monaco criteria was good (0.65), while the diagnostic IA using CRM was fair (0.58). The overall diagnostic accuracy using the Monaco classification was 61% and CRM criteria were 57%. CONCLUSION: The IOA and accuracy rate of DSOC using visual criteria from both Monaco Criteria and CRM are similar. However, some criteria from both sets suffer from poor IA, thus affecting the overall diagnostic accuracy. More formal training and refinements in visual criteria with additional validation are needed to improve diagnostic accuracy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02166099.

Needle-based confocal endomicroscopy in the discrimination of mucinous from non-mucinous pancreatic cystic lesions.

BACKGROUND: Pancreatic cystic lesions (PCLs) are considered a precursor of pancreatic cancer. Needle-based confocal endomicroscopy (nCLE) is an imaging technique that enables visualization of the mucosal layer to a micron resolution. Its application has demonstrated promising results in the distinction of PCLs. This study evaluated the utility of nCLE in patients with indeterminate PCLs undergoing endoscopic ultrasound fine-needle aspiration (EUS-FNA) to distinguish mucinous from non-mucinous lesions. AIM: To evaluate the accuracy of nCLE in indeterminate PCLs undergoing EUS-FNA to distinguish mucinous from non-mucinous lesions. METHODS: Patients who required EUS-FNA between 2015 and 2017 were enrolled prospectively. During EUS-FNA, confocal imaging, analyses of the tumor markers carcinoembryonic antigen and amylase, and cytologic examination were conducted. All patients were followed for at least 12 mo and underwent laboratory testing and computed tomography scanning or magnetic resonance imaging. nCLE videos were independently reviewed by 6 observers to reach a final diagnosis (mucinous vs non-mucinous) based on criteria derived from previous studies; if there was disagreement > 20%, a final diagnosis was discussed after consensus re-evaluation. The sensitivity, specificity, and accuracy of nCLE were calculated. Adverse events were recorded. RESULTS: Fifty-nine patients were included in this study. Final diagnoses were derived from surgery in 10 patients, cytology in 13, and imaging and multidisciplinary team review in 36. Three patients were excluded from final diagnosis due to problems with nCLE acquisition. Fifty-six patients were included in the final analysis. The sensitivity, specificity, and accuracy of nCLE were 80% [95% confidence interval (CI): 65-90], 100% (95%CI: 72-100), and 84% (95%CI: 72-93), respectively. Post-procedure acute pancreatitis occurred in 5%. CONCLUSION: EUS-nCLE performs better than standard EUS-FNA for the diagnosis of indeterminate PCL.

Factors associated with risk of COVID-19 contagion for endoscopy healthcare workers: A survey from the Italian society of digestive endoscopy.

BACKGROUND AND AIMS: The present study was aimed to assess the risk of SARS-CoV-2 infection and associated factors among HCWs in endoscopy centers in Italy. METHODS: All members of the Italian Society of Digestive Endoscopy (SIED) were invited to participate to a questionnaire-based survey during the first months of the COVID-19 outbreak in Italy. RESULTS: 314/1306 (24%) SIED members accounting for 201/502 (40%) endoscopic centers completed the survey. Personal Protection Equipment (PPE) were available in most centers, but filtering face-piece masks (FFP2 or FFP3) and negative pressure room were not in 10.9 and 75.1%. Training courses on PPE use were provided in 57.2% of centers only; there was at least one positive HCW in 17.4% of centers globally, 107/3308 (3.2%) HCWs were diagnosed with COVID-19 with similar rates of physicians (2.9%), nurses (3.5%) and other health operators (3.5%). Involvement in a COVID-19 care team (OR: 4.96) and the lack of training courses for PPE, (OR: 2.65) were associated with increased risk. CONCLUSIONS: The risk of COVID-19 among endoscopy HCWs was not negligible and was associated with work in a COVID-19 care team and lack of education on proper PPE use. These data deserve attention during the subsequent waves.