The Gastropack Access System as a Model to Access Gastroenterology Services for Gastroscopy Appropriateness in Patients with Upper Gastrointestinal Symptoms: A Comparison with the Open Access System.

Esophagogastroduodenoscopy (EGD) appropriateness in Open-Access System (OAS) is a relevant issue. The Gastropack Access System (GAS) is a new system to access gastroenterological services, based on the partnership between Gastroenterologists and GPs. This study aims to evaluate if GAS is superior to OAS in terms of EGDS appropriateness. Secondarily, we evaluated the diagnostic yield of EGDS according to ASGE guidelines. The GAS was developed in an area of Bologna where General Practitioners (GPs) could decide to directly prescribe EGDS through OAS or referring to GAS, where EGDS can be scheduled after contact between GPs and specialists sharing a patient's clinical information. Between 2016 and 2019, 2179 cases (M:F = 861:1318, median age 61, IQR 47.72) were referred to GAS and 1467 patients (65%) had a prescription for EGDS; conversely, 874 EGDS were prescribed through OAS (M:F = 383:491; median age 58 yrs, IQR 45.68). Indication was appropriate in 92% in GAS (1312/1424) versus 71% in OAS (618/874), p < 0.001. The rate of clinically significant endoscopic findings (CSEF) was significantly higher in GAS (49% vs. 34.8%, p < 0.001). Adherence to ASGE guidelines was not related to CSEF; however, surveillance for pre-malignant conditions was independently related to CSEF. All neoplasm were observed in appropriate EGD. GAS is an innovative method showing extremely high rates of appropriateness. ASGE guidelines confirmed their validity for cancer detection, but their performance for the detection of other conditions needs to be refined.

Clinical practice patterns in indirect peroral cholangiopancreatoscopy: outcome of a European survey.

Background and aims Indirect peroral cholangiopancreatoscopy (IPOC) is a relatively new diagnostic and therapeutic tool for biliopancreatic diseases. This international survey aimed to evaluate clinical practice patterns in IPOC among endoscopists in Europe. Methods An online survey was developed comprising 66 questions on the use of IPOC. Questions were grouped into four domains. The survey was sent to 369 endoscopists who perform IPOC. Results 86 respondents (23.3 %) from 21 different countries across Europe completed the survey. The main indications for cholangioscopy were determination of biliary strictures (85 [98.8 %]) and removal of common bile duct or intrahepatic duct stones (79 [91.9 %]), accounting for an estimated use of 40 % (interquartile range [IQR] 25-50) and 40 % (IQR 30-60), respectively, of all cases undergoing cholangioscopy. Pancreatoscopy was mainly used for removal of pancreatic duct stones (68/76 [89.5 %]), accounting for an estimated use of 76.5 % (IQR 50-95) of all cases undergoing pancreatoscopy. Only 13/85 respondents (15.3 %) had an institutional standardized protocol for targeted cholangioscopy-guided biopsy sampling. IPOC with lithotripsy was used as first-line treatment in selected patients with bile duct stones or pancreatic stones by 24/79 (30.4 %) and 53/68 (77.9 %) respondents, respectively. Conclusions This first European survey on the clinical practice of IPOC demonstrated wide variation in experience, indications, and techniques. These results emphasize the need for prospective studies and development of an international consensus guideline to standardize the practice and quality of IPOC.

The clinical utility of a comprehensive psychosomatic assessment in the program for colorectal cancer prevention: a cross-sectional study.

Few studies have investigated psychosocial characteristics and lifestyle behaviors of participants at programs for secondary prevention of colorectal cancer (CRC). This study aimed, through a comprehensive psychosomatic assessment based on clinimetric principles, to evaluate psychosocial characteristics and lifestyle behaviors in participants at CRC secondary prevention program, and to investigate the associations between these variables and endoscopic outcomes. In this cross-sectional study, the first 150 consecutive asymptomatic participants at the CRC prevention program who resulted positive to fecal occult blood test (FOBT) and were thus referred to colonoscopy, underwent a psychosomatic assessment including psychiatric diagnoses (DSM-5), psychosomatic syndromes (DCPR-R), psychological distress, psychological well-being and lifestyle behaviors. Whereas only 5.3% of the sample showed at least one DSM-5 diagnosis, 51.3% showed at least one DCPR syndrome, such as allostatic overload, alexithymia, Type A behavior, and demoralization. Patients affected by psychosomatic syndromes presented with significantly higher psychological distress, lower psychological well-being and unhealthy lifestyle behaviors, such as tobacco smoking and unhealthy diet, in comparison with patients without DCPR syndromes. Among endoscopic outcomes, the presence of adenomas was significantly associated with DCPR irritable mood. In a clinical context of secondary prevention addressing asymptomatic patients with positive FOBT, a comprehensive psychosomatic assessment may provide relevant clinical information for those patients who present certain psychosomatic syndromes associated with high psychological distress, impaired psychological well-being, unhealthy lifestyle behaviors and colorectal precancerous lesions. The results of the present study indicate a road to the practice of "preventive" medicine at CRC screening program.

Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures.

BACKGROUND AND AIMS: Digital single-operator cholangioscopy (d-SOC) with cholangioscopic biopsy sampling has shown promise in the evaluation of indeterminate biliary strictures. Some studies have suggested higher sensitivity for visual impression compared with biopsy sampling, although assessors were not blinded to previous investigations. We aimed to investigate the diagnostic accuracy and interobserver agreement (IOA) of d-SOC in the visual appraisal of biliary strictures when blinded to additional information. METHODS: A multicenter, international cohort study was performed. Cholangioscopic videos in patients with a known final diagnosis were systematically scored. Pseudonymized videos were reviewed by 19 experts in 2 steps: blinded for patient history and investigations and unblinded. RESULTS: Forty-four high-quality videos were reviewed of 19 benign and 25 malignant strictures. The sensitivity and specificity for the diagnosis of malignancy was 74.2% and 46.9% (blinded) and 72.7% and 62.5% (unblinded). Cholangioscopic certainty of a malignant diagnosis led to overdiagnosis (sensitivity, 90.6%; specificity, 33%), especially if no additional information was provided. The IOA for the presence of malignancy was fair for both assessments (Fleiss' κ = .245 [blinded] and κ = .321 [unblended]). For individual visual features, the IOA ranged from slight to moderate for both assessments (κ = .059-.400 vs κ = .031-.452). CONCLUSIONS: This study showed low sensitivity and specificity for blinded and unblinded d-SOC video appraisal of indeterminate biliary strictures, with considerable interobserver variation. Although reaching a consensus on the optical features of biliary strictures remains important, optimizing visually directed biopsy sampling may be the most important role of cholangioscopy in biliary stricture assessment.

Micro-Biopsy Forceps in the Assessment of Peritoneal Carcinomatosis: A Possible New Indication?

Peritoneal carcinomatosis (PC) is defined as a metastatic involvement of the peritoneum by several other primary sites and it is characterized by a marked worsening of prognosis, with limited treatment opportunities. Subsequently, PC should be ruled out before any invasive treatment is administered. A new through-the-needle micro-biopsy forceps (MF) was recently introduced that permits micro-histology cores. In this case series, we evaluated the feasibility of MF in the assessment of PC to complete patient diagnostic work-ups. Five consecutive patients referred for endoscopic ultrasound staging were sampled using MF. Sampling was feasible in all patients with a technical success of 100%. No adverse events were reported in any cases. This technique was feasible and safe with a technical success rate of 100%. It permitted sampling of peritoneal irregularity, obtained high-quality tissue fragments in all cases, and enabled an additional assessment, i.e., immunohistochemical staining.

Redesign of a GI endoscopy unit during the COVID-19 emergency: A practical model.

The pandemic diffusion of the SARS-CoV-2 infection throughout the world required measures to prevent and strategies to control the infection, as well as the reallocation of the hospital structures in order to take care of an increased number of infected patients. Endoscopy Units should be able to perform endoscopic procedures on COVID-19 infected as well as on noninfected patients. The aim of this manuscript is to propose a model for a fast reorganization of the endoscopy department environment in order to safely perform endoscopic procedures in this Pandemic COVID-19 scenario, according to the current advices given by the Scientific Societies.

Intra-procedural and delayed bleeding after resection of large colorectal lesions: The SCALP study.

Background and aim: The safety of endoscopic resection of large colorectal lesions (LCLs) (≥20 mm) is clinically relevant. The aim of the present study was to assess the rate of post-resection adverse events (AEs) in a real-life setting. Patients and methods: In a prospective, multicentre, observational study, data from consecutive resections of LCLs over a 6-month period were collected in 24 centres. Patients were followed up at 15 days from resection for AEs. The primary endpoint was intra-procedural bleeding according to lesion morphology. Secondary endpoints were delayed bleeding and perforation. Patient and polyp characteristics, and polypectomy techniques were analysed with respect to the bleeding events. Results: In total, 1504 patients (female/male: 633/871, mean age, 66.1) with 1648 LCLs (29.1% pedunculated and 70.9% non-pedunculated lesions) were included. Overall, 168 (11.2%) patients had post-resection bleeding (8.5 and 2.0% immediate and delayed, respectively), while 15 (1.0%) cases of perforation occurred. Independent predictors of immediate bleeding for pedunculated lesions were bleeding prophylaxis (odds ratio (OR) 0.28, 95% confidence interval (CI) 0.13-0.62), simple polypectomy (versus endoscopic mucosal resection, OR 0.38, 95% CI 0.17-0.88) and inpatient setting (OR 2.21, 95% CI 1.07-5.08), while bleeding prophylaxis (OR 0.37, 95% CI 0.30-0.98), academic setting (OR 0.27, 95% CI 0.12-0.54) and size (OR 1.03, 95% CI 1.00-1.05) were predictors for those non-pedunculated. Indication for colonoscopy (screening versus diagnostic (OR 0.33, 95% CI 0.12-0.86)), antithrombotic therapy (OR 3.12, 95% CI 1.54-6.39) and size (OR 2.34, 95% CI 1.12-4.87) independently predicted delayed bleeding. Conclusions: A low rate of post-resection AEs was observed in a real-life setting, reassuring as to the safety of endoscopic resection of ≥2 cm colorectal lesions. Bleeding prophylaxis reduced the intra-procedural bleeding risk, while antithrombotic therapy increased delayed bleeding.CLINICALTRIAL: (NCT02694120).

High diagnostic adequacy and accuracy of the new 20G procore needle for EUS-guided tissue acquisition: Results of a large multicentre retrospective study.

BACKGROUND AND OBJECTIVE: EUS-guided fine-needle biopsy has become the standard for tissue sampling. A new 20G ProCore™ (PC) needle has been developed to overcome the limitations of tissue acquisition of the smaller needles (22G, 25G) and the rigidity of the larger one (19G). The aim of this study is to assess the performance of the 20G PC needle. MATERIALS AND METHODS: Patients who underwent EUS-guided tissue acquisition with the 20G PC needle of pancreatic and extra-pancreatic mass lesions were retrospectively identified at three Italian centers (Bologna, Fermo, and Palermo). Diagnostic adequacy, accuracy, and tissue core acquisition were the outcome measures. All the cases were performed without rapid on-site evaluation. RESULTS: A total of 384 patients with pancreatic (62.2%) and extra-pancreatic lesions were included in the study. For pancreatic lesions, adequacy, accuracy, sensitivity, and specificity were 92.4%, 91.5%, 90.8%, and 100%, respectively, with a number needed to misdiagnose (NNM) of 11.8. The tissue core was obtained in 72% of cases. Transduodenal approach was performed in 150 pancreatic lesions; adequacy, accuracy, and tissue core acquisition were 88.7%, 90%, and 66%, respectively (NNM 10). For extrapancreatic lesions, adequacy, accuracy, sensitivity, specificity, and tissue core sampling were 95.3%, 95.3%, 92.6%, 100%, and 84.5% (NNM 21.3). CONCLUSIONS: The 20G PC needle showed high diagnostic adequacy and accuracy, regardless the access route.

Beyond palliation: using EUS-guided choledochoduodenostomy with a lumen-apposing metal stent as a bridge to surgery. a case series.

We present five cases of pylorus-preserving pancreaticoduodenectomy (PPPD) after endoscopic ultrasonography-guided choledochoduodenostomy (EUS-CD) using a lumen-apposing metal stent (LAMS) as a bridge to surgery in patients with resectable distal malignant biliary obstruction and failed endoscopic retrograde cholangiopancreatography (ERCP). The patients underwent an EUS-CD using EC-LAMS, the bile duct being accessed using the transbulbar approach. The technical success rate of EUS-CD was 100%. No procedure-related adverse events occurred. All patients underwent PPPD with a technical success rate of 100%. The presence of a transduodenal LAMS did not impede surgery. No biliary or duodenal fistula occurred in the patients. Pancreatic fistulas with late bleeding were observed in two patients (one fatal). These few cases indicate that PPPD after EUS-CD using LAMS is feasible and safe. EUS-CD should be performed irrespective of the stage of the disease, also for patients fit for surgery. Additional larger prospective studies are required to confirm this preliminary data, in particular for possible interference with postoperative outcomes.

Matricellular proteins and survival in patients with pancreatic cancer: A systematic review.

Extracellular matrix (ECM) plays a fundamental role in tissue architecture and homeostasis and modulates cell functions through a complex interaction between cell surface receptors, hormones, several bioeffector molecules, and structural proteins like collagen. These components are secreted into ECM and all together contribute to regulate several cellular activities including differentiation, apoptosis, proliferation, and migration. The so-called "matricellular" proteins (MPs) have recently emerged as important regulators of ECM functions. The aim of our review is to consider all different types of MPs family assessing the potential relationship between MPs and survival in patients with pancreatic ductal adenocarcinoma (PDAC). A systematic computer-based search of published articles, according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) Statement issued in 2009 was conducted through Ovid interface, and literature review was performed in May 2017. The search text words were identified by means of controlled vocabulary, such as the National Library of Medicine's MESH (Medical Subject Headings) and Keywords. Collected data showed an important role of MPs in carcinogenesis and in PDAC prognosis even though the underlying mechanisms are still largely unknown and data are not univocal. Therefore, a better understanding of MPs role in regulation of ECM homeostasis and remodeling of specific organ niches may suggest potential novel extracellular targets for the development of efficacious therapeutic strategies.

Team work and cytopathology molecular diagnosis of solid pancreatic lesions.

Pancreatic ductal adenocarcinoma (PDAC) is expected to become the second leading cause of cancer-associated death in the next decade or so. It is widely accepted that tumorigenesis is linked to specific alterations in key genes and pancreatic neoplasms are some of the best characterized at the genomic level. Recent whole-exome and whole-genome sequencing analyses confirmed that PDAC is frequently characterized by mutations in a set of four genes among others: KRAS, TP53, CDKN2A/p16, and SMAD4. Sequencing, for example, is the preferable technique available for detecting KRAS mutations, whereas in situ immunochemistry is the main approach for detecting TP53 gene alteration. Nevertheless, the diagnosis of PDAC is still a clinical challenge, involving adequate acquisition of endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) and specific pathological assessment from tissue architecture to specific biomolecular tests. The aim of the present review is to provide a complete overview of the current knowledge of the biology of pancreatic cancer as detected by the latest biomolecular techniques and, moreover, to propose a paradigm for strict teamwork collaboration in order to improve the correct use of diagnostic sources.

The presence of rapid on-site evaluation did not increase the adequacy and diagnostic accuracy of endoscopic ultrasound-guided tissue acquisition of solid pancreatic lesions with core needle.

BACKGROUND: Rapid on-site evaluation (ROSE) improves the adequacy and accuracy of EUS-guided tissue acquisition, although it is not routinely widely available. Evidence suggested that core needles might overcome the absence of ROSE. The aim of this study was to evaluate the influence of ROSE on the adequacy and accuracy of EUS-guided tissue acquisition with core needles in patients with pancreatic solid lesions. METHODS: Patients who underwent EUS-guided tissue acquisition of pancreatic mass lesions were retrospectively identified at three tertiary referral centers and those performed with the core needle were included. Adequacy, defined as the rate of cases in which a tissue specimen for proper examination was achieved, with and without ROSE was the primary outcome measure. The diagnostic accuracy and tissue core acquisition were the secondary outcome measures. RESULTS: A total of 333 patients with pancreatic solid mass lesions were included in the study; 140 cases sampled with ROSE and 193 cases without ROSE. The adequacy was 92.1 % in the group sampled with ROSE and 88.1 % in the group without ROSE (p = 0.227). In the ROSE group sensitivity, specificity, and accuracy were 90.7, 100 and 92.1 %, respectively. In the group without ROSE, sensitivity, specificity, and accuracy were 87.2, 100, and 88.1 %, respectively. No difference for all these figures was observed between the two groups. The tissue core was available in 61.4 and 53.4 % of cases with and without ROSE, respectively (p = 0.143). CONCLUSION: In the absence of ROSE, EUS-based tissue acquisition with Core needle should be considered since it achieves comparable tissue sampling adequacy and accuracy.

Pancreatic necrosectomy: an evidence-based systematic review of the levels of evidence and a comparison of endoscopic versus non-endoscopic techniques.

INTRODUCTION: Endoscopic necrosectomy is now becoming common worldwide as a minimally-invasive treatment alternative to surgical necrosectomy. The aims of this systematic review are to record the entire body of the literature accumulated over the past 15 years on endoscopic necrosectomy techniques and to compare the outcomes of endoscopic versus non-endoscopic techniques. EVIDENCE ACQUISITION: All relevant articles were extracted up to December 2015 based on the results of searches in PubMed, Scopus and Google Scholar. EVIDENCE SYNTHESIS: A total of 46 pertinent articles were finally included for the purpose of this systematic review. Most of the studies in our review included small numbers of patients, were retrospective and had low/moderate overall levels of evidence. The mean technical and clinical success rates reported were 99% and 89%, respectively, the mean overall complication rate was 22% and the mean overall mortality rate was 5%. The most common complications were bleeding, which occurred in 11% of patients, perforations/pneumoperitoneum which occurred in 3%, and air embolism in 0.4% of patients. The access to the cavity was created by direct endoscopic puncture in 205 patients, while endoscopic ultrasound guidance was used in 733, with no difference in technical success (99% vs. 99%), clinical success (87% vs. 89%), complications (32% vs. 21%) and mortality (7% vs. 5%) rates. Compared to the percutaneous and surgical therapies, the endoscopic techniques exhibited higher success rates and lower morbidity and mortality rates. CONCLUSIONS: Endoscopic necrosectomy is becoming the standard of care for the treatment of pancreatic necrotic collections.

Current status of peroral cholangioscopy in biliary tract diseases.

Peroral cholangioscopy (POC) is an important tool for the management of a selected group of biliary diseases. Because of its direct visualization, POC allows targeted diagnostic and therapeutic procedures. POC can be performed using a dedicated cholangioscope that is advanced through the accessory channel of a duodenoscope or via the insertion of a small-diameter endoscope directly into the bile duct. POC was first described in the 1970s, but the use of earlier generation devices was substantially limited by the cumbersome equipment setup and high repair costs. For nearly ten years, several technical improvements, including the single-operator system, high-quality images, the development of dedicated accessories and the increased size of the working channel, have led to increased diagnostic accuracy, thus assisting in the differentiation of benign and malignant intraductal lesions, targeting biopsies and the precise delineation of intraductal tumor spread before surgery. Furthermore, lithotripsy of difficult bile duct stones, ablative therapies for biliary malignancies and direct biliary drainage can be performed under POC control. Recent developments of new types of conventional POCs allow feasible, safe and effective procedures at reasonable costs. In the current review, we provide an updated overview of POC, focusing our attention on the main current clinical applications and on areas for future research.

Endoscopic ultrasound-guided fine-needle biopsy of small solid pancreatic lesions using a 22-gauge needle with side fenestration.

BACKGROUND: Early detection of small pancreatic cancer is important because expected survival is markedly better for tumors ≤ 2 cm. A new endoscopic ultrasound-(EUS) guided biopsy needle with side fenestration has been recently developed to enable fine-needle biopsy (FNB) under EUS guidance. The aim of this study was to evaluate the outcome of EUS-FNB using a 22-gauge ProCore needle in solid pancreatic lesions ≤ 2 cm, in terms of diagnostic accuracy and yield. METHODS: From January 2011 to December 2012, all consecutive EUS-guided tissue sampling of small pancreatic lesions (≤ 2 cm) were performed using 22-gauge ProCore needles; the data of these patients were analyzed retrospectively. RESULTS: Sixty-eight patients with a mean age of 65.7 years were included. The mean lesion size was 16.5 mm (range 5-20). None of the patients developed complications. On pathological examination, the tissue retrieved was judged adequate in 58 out of 68 cases (85.3 %) and the presence of a tissue core was recorded in 36 out of 68 cases (52.9 %). The overall sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 80, 100, 100, 40, and 82 %, respectively. CONCLUSION: Our results suggested that EUS-FNB of small pancreatic lesions using a 22-gauge ProCore needle is effective and safe, and supports our hypothesis that EUS-FNB is highly useful in establishing the nature of small pancreatic lesions.

Management of inoperable malignant oesophageal strictures with fully covered WallFlex(®) stent: a multicentre prospective study.

BACKGROUND: The majority of currently available oesophageal metal stents are partially covered to reduce migration risk. Preliminary experiences with fully covered stents seem to indicate an increased risk of migration in patients treated for malignant dysphagia. The aim of our study was to determine, in this setting, the safety and efficacy of a new, recently introduced stent with anti-migration proprieties. METHODS: We designed a prospective, multicentre, non-randomized, follow-up study in nine tertiary referral centres. Eighty-two patients with dysphagia due to inoperable or metastatic oesophageal cancer were included. In all of them the fully covered WallFlex(®) stent was placed. Main outcome measurements included functional outcome, recurrent dysphagia, complications, and mortality. RESULTS: Dysphagia score improved from a median of 3, before stenting, to 1 at 4 weeks after stent placement (P<0.001). Perforation occurred in 1 patient after 39 days, while bleeding was reported in 3. In total, 19 patients (23.1%) developed recurrent dysphagia because of stent migration (N=10, 12.2%), tissue overgrowth (N=7; 8.5%), and food impaction (N=2; 2.4%). CONCLUSIONS: Placement of the fully covered WallFlex(®) stent resulted in safe and effective palliation of malignant dysphagia, with migration and tissue overgrowth rates comparable to previously reported data on partially covered stents.