Establishing the optimal number of passes during EUS-FNB for diagnosis of pancreatic solid lesions: Prospective multicenter study.

Background and study aims The optimal number of needle passes during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) is not yet established. We aimed to perform a per-pass analysis of the diagnostic accuracy of EUS-FNB of solid pancreatic lesions using a 22G Franseen needle. Patients and methods Consecutive patients with solid pancreatic lesions referred to 11 Italian centers were prospectively enrolled. Three needle passes were performed; specimens were collected after each pass and processed individually as standard histology following macroscopic on-site evaluation (MOSE) by the endoscopist. The primary endpoint was diagnostic accuracy of each sequential pass. Final diagnosis was established based on surgical pathology or a clinical course of at least 6 months. Secondary endpoints were specimen adequacy, MOSE reliability, factors impacting diagnostic accuracy, and procedure-related adverse events. Results A total of 504 samples from 168 patients were evaluated. Diagnostic accuracy was 90.5% (85.0%-94.1%) after one pass and 97.6% (94.1%-99.3%) after two passes ( P =0.01). Similarly, diagnostic sensitivity and sample adequacy were significantly higher adding the second needle pass (90.2%, 84.6%-94.3% vs 97.5%, 93.8%-99.3%, P =0.009 and 91.1%, 85.7%-94.9% vs 98.2%, 95.8%-99.3%, P =0.009, one pass vs two passes, respectively). Accuracy, sensitivity, and adequacy remained the same after the third pass. The concordance between MOSE and histological evaluation was 89.9%. The number of passes was the only factor associated with accuracy. One case of mild acute pancreatitis (0.6%) was managed conservatively. Conclusions At least two passes should be performed for the diagnosis of solid pancreatic lesions. MOSE is a reliable tool to predict the histological adequacy of specimens.

Lumen-apposing metal stents for the treatment of pancreatic and peripancreatic fluid collections and bleeding risk: a propensity matched study.

INTRODUCTION: Endoscopic ultrasound (EUS)-guided drainage of symptomatic pancreatic fluid collections (PFCs) using the Hot-Axios device has recently been associated with a significant risk of bleeding. This adverse event (AE) seems to occur less frequently with the use of a different device, the Spaxus stent. The aim of the current study was to compare the rates of bleeding between the two stents. METHODS: Patients admitted for treatment of PFCs by EUS plus lumen-apposing metal stent in 18 endoscopy referral centers between 10 July 2019 and 28 February 2022 were identified and their outcomes compared using a propensity-matching analysis. RESULTS: 363 patients were evaluated. After a 1-to-1 propensity score match, 264 patients were selected (132 per group). The technical and clinical success rates were comparable between the two groups. Significantly more bleeding requiring transfusion and/or intervention occurred in the Hot-Axios group than in the Spaxus group (6.8% vs. 1.5%; P = 0.03); stent type was a significant predictor of bleeding in both univariate and multivariate regression analyses (P = 0.03 and 0.04, respectively). Bleeding necessitating arterial embolization did not however differ significantly between the two groups (3.0% vs. 0%; P = 0.12). In addition, the Hot-Axios was associated with a significantly higher rate of overall AEs compared with the Spaxus stent (9.8% vs. 3.0%; P = 0.04). CONCLUSION: Our study showed that, in patients with PFCs, bleeding requiring transfusion and/or intervention occurred significantly more frequently with use of the Hot-Axios stent than with the Spaxus stent, although this was not the case for bleeding requiring embolization.

The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study.

BACKGROUND: Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy. METHODS: This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate. RESULTS: A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding. CONCLUSIONS: Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.

The Use of a New Dedicated Electrocautery Lumen-Apposing Metal Stent for Gallbladder Drainage in Patients with Acute Cholecystitis.

Aims: Lumen-apposing metal stents (LAMSs) in ultrasonography-guided gallbladder drainage (EUS-GBD) have become increasingly important for high-risk surgical patients. Our study aims to evaluate the technical and clinical success, safety, and feasibility of endoscopic ultrasonography-guided gallbladder drainage using a new dedicated LAMS. Methods: This is a retrospective multicenter study that included all consecutive patients not suitable for surgery who were referred to a tertiary center for EUS-GBD using a new dedicated electrocautery LAMS for acute cholecystitis at eight different centers. Results: Our study included 54 patients with a mean age of 76.48 years (standard deviation: 12.6 years). Out of the 54 endoscopic gallbladder drainages performed, 24 (44.4%) were cholecysto-gastrostomy, and 30 (55.4%) were cholecysto-duodenostomy. The technical success of LAMS placement was 100%, and clinical success was achieved in 23 out of 30 patients (76.67%). Adverse events were observed in two patients (5.6%). Patients were discharged after a median of 5 days post-stenting. Conclusions: EUS-GBD represents a valuable option for high-surgical-risk patients with acute cholecystitis. This new dedicated LAMS has demonstrated a high rate of technical and clinical success, along with a high level of safety.

Endoscopic full-thickness resection versus endoscopic submucosal dissection for challenging colorectal lesions: a randomized trial.

BACKGROUND AND AIMS: The optimal endoscopic resection method of challenging colorectal lesions (ie, adenomatous recurrences, nongranular laterally spreading tumors [LST-NGs], lesions without lifting sign <30 mm) is still under debate. The aim of this study was to directly compare endoscopic submucosal dissection (ESD) and endoscopic full-thickness resection (EFTR) for the resection of challenging colorectal lesions in a randomized trial. METHODS: A multicenter, prospective, randomized study was performed in 4 Italian referral centers. Consecutive patients referred for endoscopic resection of challenging lesions were randomly assigned to undergo EFTR or ESD. Primary outcomes were complete (R0) resection and en bloc resection of lesions. Technical success, procedure time, procedure speed, area of the resected specimen, adverse event rate, and local recurrence rate at 6 months were also compared. RESULTS: Overall, 90 patients were included in the study, equally representing the 3 challenging lesion types. Age and sex were comparable in the 2 groups. En bloc resection was obtained in 95.5% of the EFTR group and in 93.3% of the ESD group. R0 resection rate was comparable in the 2 groups (EFTR vs ESD, 42 [93.3%] vs 36 [80%]; P = .06). The EFTR group exhibited a significantly shorter total procedure time (25.6 ± 10.6 minutes vs 76.7 ± 26.4 minutes, P ≤ .01), as well as overall procedure speed (16.8 ± 11.8 mm2/min vs 11.9 ± 9.2 mm2/min, P = .03). The EFTR group had a significantly smaller mean lesion size (21.6 ± 8.3 mm vs 28.7 ± 7.7 mm, P ≤ .01). Adverse events were reported less frequently in patients in the EFTR group (4.44% vs 15.5%, P = .04). CONCLUSIONS: EFTR is comparable to ESD in the treatment of challenging colorectal lesions in terms of safety and efficacy. EFTR is considerably faster than ESD in the treatment of nonlifting lesions and adenoma recurrences. (Clinical trial registration number: NCT05502276.).

Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial.

BACKGROUND : The advantage of using the macroscopic on-site evaluation (MOSE) technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) performed with 22G Franseen needles has not been investigated. We aimed to compare EUS-FNB with MOSE vs. EUS-FNB performed with three needle passes. METHODS : This randomized trial involved 10 Italian referral centers. Consecutive patients referred for EUS-FNB of pancreatic or nonpancreatic solid lesions were included in the study and randomized to the two groups. MOSE was performed by gross visualization of the collected material by the endoscopists and considered adequate when a white/yellowish aggregate core longer than 10 mm was retrieved. The primary outcome was diagnostic accuracy. Secondary outcomes were specimen adequacy, number of needle passes, and safety. RESULTS : 370 patients with 234 pancreatic lesions (63.2 %) and 136 nonpancreatic lesions (36.8 %) were randomized (190 EUS-FNB with MOSE and 180 with standard EUS-FNB). No statistically significant differences were found between EUS-FNB with MOSE and conventional EUS-FNB in terms of diagnostic accuracy (90.0 % [95 %CI 84.8 %-93.9 %] vs. 87.8 % [95 %CI 82.1 %-92.2 %]; P = 0.49), sample adequacy (93.1 % [95 %CI 88.6 %-96.3 %] vs. 95.5 % [95 %CI 91.4 %-98 %]; P = 0.31), and rate of adverse events (2.6 % vs. 1.1 %; P = 0.28). The median number of passes was significantly lower in the EUS-FNB with MOSE group (1 vs. 3; P < 0.001). CONCLUSIONS : The accuracy of EUS-FNB with MOSE is noninferior to that of EUS-FNB with three needle passes. MOSE reliably assesses sample adequacy and reduces the number of needle passes required to obtain the diagnosis with a 22G Franseen needle.

Endoscopic management of intramural spontaneous duodenal hematoma: A case report.

BACKGROUND: Intramural duodenal hematoma is a rare condition described for the first time in 1838. This condition is usually associated with blunt abdominal trauma in children. Other non-traumatic risk factors for spontaneous duodenal haematoma include several pancreatic diseases, coagulation disorders, malignancy, collagenosis, peptic ulcers, vasculitis and upper endoscopy procedures. In adults the most common risk factor reported is anticoagulation therapy. The clinical presentation may vary from mild abdominal pain to acute abdomen and intestinal obstruction or gastrointestinal bleeding. CASE SUMMARY: The aim of this case summary is to show a case of intramural spontaneous hematoma with symptoms of intestinal obstruction that was properly drained endoscopically by an innovative system lumen-apposing metal stent Hot AXIOS™ stent (Boston Scientific Corp., Marlborough, MA, United States). CONCLUSION: Endoscopic lumen-apposing metal stent Hot AXIOS™ stent is a safe and feasible treatment of duodenal intramural hematoma in our case.

Common bile duct size in malignant distal obstruction and lumen-apposing metal stents: a multicenter prospective study.

Background and study aims Feasibility of EUS-guided choledochoduodenostomy (EUS-CDS) using available lumen-apposing stents (LAMS) is limited by the size of the common bile duct (CBD) (≤ 12 mm, cut-off for experts; 15 mm, cut-off for non-experts). We aimed to assess the prevalence and predictive factors associated with CBD size ≥ 12 and 15 mm in naïve patients with malignant distal biliary obstruction (MDBO). Patients and methods This was a prospective cohort study involving 22 centers with assessment of CBD diameter and subjective feasibility of the EUS-CDS performance in naïve jaundiced patients undergoing EUS evaluation for MDBO. Results A total of 491 patients (mean age 69 ±â€Š12 years) with mean serum bilirubin of 12.7 ±â€Š6.6 mg/dL entered the final analysis. Dilation of the CBD ≥ 12 and 15 mm was detected in 78.8 % and 51.9 % of cases, respectively. Subjective feasibility of EUS-CDS was expressed by endosonographers in 91.2 % for a CBD ≥ 12 mm and in 96.5 % for a CBD ≥ 15 mm. On multivariate analysis, age ( P  < 0.01) and bilirubin level ( P  ≤ 0.001) were the only factors associated with both CBD dilation ≥ 12 and ≥ 15 mm. These variables were poorly associated with the extent of duct dilation; however, based on them a prediction model could be constructed that satisfactorily predicted CBD size ≥ 12 mm in patients at least 70 years and a bilirubin level ≥ 7 mg/dL. Conclusions Our study showed that at presentation in a large cohort of patients with MDBO, EUS-CDS can be potentially performed in three quarters to half of cases by expert and less experienced endosonographers, respectively. Dedicated stents or devices with different designs able to overcome the limitations of existing electrocautery-enhanced LAMS for EUS-CDS are needed.

Quick, safe and effective repair of EUS-related duodenal perforation using over-the-scope clip system (with video).

Duodenal perforation is a rare but potentially life-threating complication of bilio-pancreatic endoscopic-ultrasound (EUS) examination. Here we report a case of 90 yeas-old patient underwent to EUS with curvilinear ecoendoscope and complicated by duodenal wall perforation. As reported in our case, Over-the-scope clipping system represents a quick, safe and effective approach in order close the leak and prevent further complication.

First-line endoscopic treatment with OTSC in patients with high-risk non-variceal upper gastrointestinal bleeding: preliminary experience in 40 cases.

BACKGROUND AND STUDY AIMS: The over-the-scope clip (OTSC; Ovesco, Tübingen, Germany) is a novel endoscopic clipping device designed for tissue approximation. The device has been used in the closure of fistulas and perforations. We hereby report a series of patients with high-risk non-variceal upper gastrointestinal bleeding (NVUGIB) lesions in whom OTSCs were used as first-line endoscopic treatment. PATIENTS AND METHODS: We prospectively collected and retrospectively analysed data over a period of 12 months from October 2013 to November 2014 from all consecutive patients who underwent emergency endoscopy for acute severe high-risk NVUGIB and were treated with OTSC as primary first-line therapy. RESULTS: We included forty consecutive patients with mean age 69 years (range 25-94 years). All patients were treated with the non-traumatic version of the OTSC system (23 with the 11 mm version and 17 with the 12 mm version). Indications for OTSC treatment included gastric ulcer with large vessel (Forrest IIa) (n = 8, 20 %), duodenal ulcer (Forrest Ib) (n = 7, 18 %), duodenal ulcer with large vessel (Forrest IIa) (n = 6, 15 %), Dieulafoy's lesion (n = 6, 15 %) and other secondary indications (n = 13, 32 %). Technical success and primary haemostasis were achieved in all patients (100 %). No re-bleeding, need for surgical or radiological embolization treatment or other complications were observed during the follow-up period of 30 days. CONCLUSIONS: We conclude OTSC placement as a first-line endoscopic treatment seems to be effective, safe and easy to perform and should be considered in patients with high-risk NVUGIB lesions.

Cholangiocarcinoma and malignant bile duct obstruction: A review of last decades advances in therapeutic endoscopy.

In the last decades many advances have been achieved in endoscopy, in the diagnosis and therapy of cholangiocarcinoma, however blood test, magnetic resonance imaging, computed tomography scan may fail to detect neoplastic disease at early stage, thus the diagnosis of cholangiocarcinoma is achieved usually at unresectable stage. In the last decades the role of endoscopy has moved from a diagnostic role to an invaluable therapeutic tool for patients affected by malignant bile duct obstruction. One of the major issues for cholangiocarcinoma is bile ducts occlusion, leading to jaundice, cholangitis and hepatic failure. Currently, endoscopy has a key role in the work up of cholangiocarcinoma, both in patients amenable to surgical intervention as well as in those unfit for surgery or not amenable to immediate surgical curative resection owing to locally advanced or advanced disease, with palliative intention. Endoscopy allows successful biliary drainage and stenting in more than 90% of patients with malignant bile duct obstruction, and allows rapid reduction of jaundice decreasing the risk of biliary sepsis. When biliary drainage and stenting cannot be achieved with endoscopy alone, endoscopic ultrasound-guided biliary drainage represents an effective alternative method affording successful biliary drainage in more than 80% of cases. The purpose of this review is to focus on the currently available endoscopic management options in patients with cholangiocarcinoma.

PDX-1 mRNA expression in endoscopic ultrasound-guided fine needle cytoaspirate: perspectives in the diagnosis of pancreatic cancer.

BACKGROUND AND AIMS: Endoscopic ultrasound-guided fine needle aspiration is routinely used in the diagnostic work up of pancreatic cancer but has a low sensitivity. Studies showed that Pancreatic Duodenal Homeobox-1 (PDX-1) is expressed in pancreatic cancer, which is associated with a worse prognosis. We aimed to verify whether the assessment of PDX-1 in endoscopic ultrasound-guided fine needle aspiration samples may be helpful for the diagnosis of pancreatic cancer. METHODS: mRNA of 54 pancreatic cancer and 25 cystic lesions was extracted. PDX-1 expression was assessed by Real-Time PCR. RESULTS: In all but two patients with pancreatic cancer, PDX-1 was expressed and was found positive in 7 patients with pancreatic cancer in which cytology was negative. The positivity was associated with a probability of 0.98 (95% CI 0.90-1.00) of having cancer and the negativity with one of 0.08 (95% CI 0.01-0.27). The probability of cancer rose to 1.00 (95% CI 0.97-1.00) for patients positive to both PDX-1 and cytology and fell to 0.0 (95% CI 0.00-0.15) in patients negative for both. CONCLUSIONS: PDX-1mRNA is detectable in samples of pancreatic cancer. Its quantification may be helpful to improve the diagnosis of pancreatic cancer.

Fully covered self-expanding metal stents for refractory anastomotic colorectal strictures.

BACKGROUND: Some patients with benign colorectal obstruction do not respond to endoscopic balloon dilation. Fully covered self-expandable metal stents (FCSEMSs) have several potential advantages over non-covered stents, including a higher likelihood of retrieval owing to limited local tissue reaction. However, the efficacy and safety of FCSEMSs in benign colorectal strictures have not yet been established. METHODS: Retrospective analysis of prospectively collected data concerning patients with post-surgical benign symptomatic anastomotic colorectal strictures, refractory to endoscopic dilation and in whom FCSEMSs had been placed at our center. Technical success was defined as successful stent placement and deployment at the stricture site. Early clinical success was defined as symptom relief persisting at least for 3 days. Follow-up was based on monthly clinical evaluation and quarterly endoscopic assessment. Endoscopic stent removal was planned on the basis of clinical or endoscopic assessment. Prolonged clinical success was defined as persistent symptom relief during follow-up. RESULTS: Technical and early clinical success were obtained in 16 of 16 (100%) patients. The median follow-up was 21 months. Prolonged clinical success was achieved in 9/16 (56%) cases. There was no major complication, including perforation and bleeding. Stent migration occurred in 3 (19%) cases, in two of them associated with clinical failure. The median stent diameter was significantly higher in patients with successful than in those with unsuccessful clinical outcome (26 vs. 20 mm, P = 0.006). The clinical success rate was 1/6 (17%) in patients who received a 20-22 mm stent and 8/10 (80%) in those who received a 24-26 mm stent, respectively (P = 0.035). CONCLUSIONS: FCSEMSs can represent effective and safe treatment for refractory anastomotic colorectal strictures. Large diameter stents are warranted for better results.

Pancreatic duct stenting for the duration of ERCP only does not prevent pancreatitis after accidental pancreatic duct cannulation: a prospective randomized trial.

BACKGROUND: Pancreatic duct stent placement during endoscopic retrograde cholangiopancreatography (ERCP) has been recommended in patients at risk for post-ERCP pancreatitis. However, the optimal duration of stent placement remains an open question. Our aim was to compare the efficacy of pancreatic stenting for the duration of ERCP only with spontaneous dislodgment/deferred endoscopic removal in preventing post-ERCP pancreatitis after accidental wire-guided pancreatic duct cannulation. METHODS: All patients in whom accidental wire-guided pancreatic duct cannulation had occurred during ERCP underwent immediate 5-Fr unflanged pigtail pancreatic duct stenting before attempting any other endoscopic maneuver. At the end of the ERCP, patients were randomly assigned to immediate stent removal (group A) or to leaving the stent in place (group B). Assessment of post-ERCP pancreatitis was blind. RESULTS: Post-ERCP pancreatitis occurred in 6/21 (29 %) patients in group A and in 0/19 patients in group B (P = 0.021); the two groups were well matched for their baseline characteristics. Post-ERCP pancreatitis was mild in two patients, moderate in two patients, and severe in two patients. Stents dislodged spontaneously in 14/19 (74 %) patients within 24-96 h; uneventful endoscopic removal was carried out after 96 h in 5 cases. Proximal stent migration did not occur in any case. CONCLUSIONS: Pancreatic duct stent placement for the duration of ERCP only does not prevent post-ERCP pancreatitis. Pancreatic stents should be left in place until spontaneous dislodgment occurs or endoscopic removal is deemed timely. 5-Fr unflanged pigtail stents remain in place for a period sufficient to prevent post-ERCP pancreatitis and do not migrate proximally.

i-Scan high-definition white light endoscopy and colorectal polyps: prediction of histology, interobserver and intraobserver agreement.

PURPOSE: Aim of the study was the evaluation of high-definition white light (HDWL) i-Scan endoscopy for diagnostic prediction of histology, inter- and intraobserver agreement for colorectal polyps. METHODS: In this prospective single-center cohort study, a skilled endoscopist, with HDWL i-Scan, predicted on real-time the histology of 150 polyps from 78 patients undergoing colonoscopy. Subsequently, four endoscopists, not involved in the collection of cases, predicted the polyps' histology (neoplastic vs nonneoplastic) and repeated the assessment after 6 months. RESULTS: Real-time assessment of the lesions predicted a correct histology in 138/150 cases with a sensitivity, specificity, and accuracy of 95, 82, and 92 %, respectively. Sensitivity, specificity, and accuracy of post-acquisition evaluation were 87.7, 61.7, and 82.2 %, respectively. The κ values of inter- and intraobserver agreement of prediction of histology were 0.462 (0.373-0.537) and 0.657 (0.523-0.917). Among the subset of polyps (n = 82) with good/excellent quality image, sensitivity and accuracy of HDWL i-Scan improved (97 %, p = 0.003 and 94 %, p = 0.002, respectively) as well as κ value of interobserver agreement (0.699). CONCLUSIONS: HDWL i-Scan technology helps for characterization of polyps of the colon with good accuracy even if it cannot replace, at the moment, the histopathological examination. Reproducibility among operators is supported by a moderate substantial interobserver and intraobserver agreement.