Publications by authors named "Ilaria Tarantino"

122 Publications

Digital single‑operator cholangioscopy in treating difficult biliary stones: results from a multicenter experience.

Minerva Gastroenterol (Torino) 2021 Jul 9. Epub 2021 Jul 9.

Endoscopy Unit, AOUP G. Martino, Messina, Italy.

Background: In clinical practice, standard endoscopic treatment of biliary stones fails in up to 10% of patients, and more invasive procedures such as percutaneous trans-hepatic interventions or surgery might become necessary. The aim of this multi-center retrospective study, based on prospectively-collected data, was to evaluate both the efficacy and the safety of Digital-Single Operator Cholangioscopy (D-SOC) to treat difficult biliary stones, in cases with a previous failure of conventional endoscopic methods.

Methods: Only patients with a previous failure of endoscopic standard treatment and a DSOC- based biliary stone treatment using electrohydraulic lithotripsy (EHL) or laser lithotripsy (LL) were included. The primary endpoint was to evaluate the stone clearance rate per procedure and per patient. Out of 1258 ERCP performed at our (three?) centers, 31 cholangioscopies in 21 patients were solely performed for the treatment of difficult biliary stones using EHL or LL.

Results: A complete biliary stone removal was achieved in 67.7% (21/31) of all procedures including initial and repeated examinations, while in 35.4% (11/31) of all procedures an incomplete removal was accomplished of which 36.3% had a partial stone removal. In 22 procedures EHL was adopted as techniques to fragment and remove biliary stones, while in 9 procedures LL was used. In both the techniques, the complete stone removal rate and the incomplete stone removal rate were similar (75% vs 77.7%, p>.05). Furthermore, the success rate of digital DSOC to treat difficult biliary stones was assessed per patient: overall, 100% of patients with difficult biliary stones were successfully treated using D-SOC. Only one patient experienced mild cholangitis classified ad mild adverse event following ASGE (American Society of Gastrointestinal Endoscopy) lexicon.

Conclusions: In conclusion, our data indicate that digital D-SOC assisted biliary stone treatment is highly efficient for the treatment of difficult biliary stones even in such patients in whom previous conventional endoscopic methods to treat biliary stones have failed. Therefore, D-SOC might be considered the new standard of care for these patients, being both, effective and safe.
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http://dx.doi.org/10.23736/S2724-5985.21.02892-8DOI Listing
July 2021

Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial.

Gastroenterology 2021 Jun 9. Epub 2021 Jun 9.

Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.

Background And Aims: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE.

Methods: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time.

Results: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, -1.1% to 3.1%; < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001).

Conclusions: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.).
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http://dx.doi.org/10.1053/j.gastro.2021.06.005DOI Listing
June 2021

Macroscopic on-site evaluation (MOSE) of specimens from solid lesions acquired during EUS-FNB: multicenter study and comparison between needle gauges.

Endosc Int Open 2021 Jun 27;9(6):E901-E906. Epub 2021 May 27.

Humamitas Huniversity.

The standard method for obtaining samples during endoscopic ultrasonography (EUS) is fine-needle aspiration (FNA), the accuracy of which can be affected by the presence of a cytopathologist in endoscopy room (rapid on-site evaluation [ROSE]). With the introduction of fine-needle biopsy (FNB), macroscopic on-site evaluation (MOSE) of a acquired specimen has been proposed. Only a few studies have evaluated the role of MOSE and in all except one, a 19G needle was used. Our primary aim was to evaluate the diagnostic yield and accuracy of MOSE with different needle sizes and the secondary aim was to identify factors influencing the yield of MOSE. Data from patients who underwent EUS-FNB for solid lesions, with MOSE evaluation of the specimen, were collected in six endoscopic referral centers. A total of 378 patients (145 F and 233 M) were enrolled. Needles sizes used during the procedures were 20G (42 %), 22G (45 %), and 25G (13 %). The median number of needle passes was two (IQR 2-3). The overall diagnostic yield of MOSE was of 90 % (confidence interval [CI] 86 %-92 %). On multivariable logistic regression analysis, variables independently associated with the diagnostic yield of MOSE were a larger needle diameter (20G vs. 25G, OR 11.64, 95 %CI 3.5-38.71; 22G vs. 25G, OR 6.20, 95 %CI 2.41-15.90) and three of more needle passes (OR 3.39, 95 %CI 1.38-8.31). MOSE showed high diagnostic yield and accuracy. Its yield was further increased if performed with a large size FNB needles and more than two passes.
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http://dx.doi.org/10.1055/a-1395-7129DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8159577PMC
June 2021

Acute Toxicity in Hypofractionated/Stereotactic Prostate Radiotherapy of Elderly Patients: Use of the Image-guided Radio Therapy (IGRT) Clarity System.

In Vivo 2021 May-Jun;35(3):1849-1856

Department of Radiation Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Naples, Italy.

Background: The use of intra-fractional monitoring and correction of prostate position with the Image Guided Radio Therapy (IGRT) system can increase the spatial accuracy of dose delivery. Clarity is a system used for intrafraction prostate-motion management, it provides a real-time visualization of prostate with a transperineal ultrasound. The aim of this study was to evaluate the use of Clarity-IGRT on proper intrafraction alignment and monitoring, its impact on Planning Tumor Volume margin and on urinary and rectal toxicity in elderly patients not eligible for surgery.

Patients And Methods: Twenty-five elderly prostate cancer patients, median age=75 years (range=75-90 years) were treated with Volumetric Radiotherapy and Clarity-IGRT using 3 different schemes: A) 64.5/72 Gray (Gy) in 30 fractions on prostate and seminal vesicles (6 patients); B) 35 Gy in 5 fractions on prostate and seminal vesicles (12 patients); C): 35 Gy in 5 fractions on prostate (7 patients). Ultrasound identification of the overlapped structures to the detected ones during simulation has been used in each session. A specific software calculates direction and entity of necessary shift to obtain the perfect match. The average misalignment in the three-dimensional space has been determined and shown in a box-plot.

Results: All patients completed treatment with mild-moderate toxicity. During treatment, genitourinary toxicity was 32% Grade 1; 4% Grade 2, rectal was 4% Grade 1. At follow-up of 3 months, genitourinary toxicity was 20% Grade 1; 4% Grade 2, rectal toxicity was 4% Grade 2. At follow-up of 6 months, genitourinary toxicity was 4% Grade 1; 4% Grade 2. Rectal toxicity was 4% Grade 2.

Conclusion: Radiotherapy with the Clarity System allows a reduction of PTV margins, the amount of fractions can be reduced increasing the total dose, not exacerbating urinary and rectal toxicity with greater patient's compliance.
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http://dx.doi.org/10.21873/invivo.12447DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8193305PMC
June 2021

Endoscopic ultrasonography (EUS) -guided visceral anastomoses: indications and techniques.

Minerva Gastroenterol (Torino) 2021 Apr 1. Epub 2021 Apr 1.

Gastroenterology and Endoscopy Unit, Fondazione Istituto San Raffaele-Giuseppe Giglio, Cefalù, Palermo, Italy.

Background: Technologic advancements in the field of therapeutic endoscopy have led to the development of minimally invasive techniques to create gastrointestinal anastomosis instead of surgical interventions. Examples of the potential clinical applications include bypassing malignant and benign gastric outlet obstruction, providing access to the pancreato-biliary tree in those who have undergone Roux-en-Y gastric bypass, and relieving pancreato-biliary symptoms in afferent loop syndrome.

Methods: starting from the available literature, aim of this narrative review is to summarize indications and techniques of endoscopic ultrasonography-guided visceral anastomoses.

Results: A critical review of literature on the new EUS-guided anastomoses.

Conclusions: Increasing evidences are accumulating demonstrating advantages of EUS guided visceral anastomoses. These new procedures represent a novel, minimally invasive alternative for managing different type of intestinal obstruction.
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http://dx.doi.org/10.23736/S2724-5985.21.02846-4DOI Listing
April 2021

Does Fellow Participation Increase the Adenoma Detection Rate?

Dig Dis Sci 2021 Feb 21. Epub 2021 Feb 21.

Endoscopy Service, Department of Diagnostic and Therapeutic Services, Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione, Palermo, Italy.

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http://dx.doi.org/10.1007/s10620-021-06889-4DOI Listing
February 2021

Endoscopic ultrasound-guided biliary drainage of malignant stenosis, not treatable with endoscopic retrograde cholangiopancreatography: a single-center, prospective observational study.

Endosc Int Open 2021 Feb 25;9(2):E110-E115. Epub 2021 Jan 25.

Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS - ISMETT, Palermo, Italy.

The therapeutic role of endoscopic ultrasound (EUS) evolved in recent decade,s opening a new chapter in the field of endoscopic biliary drainage (BD). EUS-BD has emerged as a new mini-invasive technique for neoplastic jaundice not amenable to endoscopic retrograde cholangiopancreatography (ERCP). The primary study aims were to assess the clinical efficacy of EUS-BD using an electrocautery-enhanced lumen apposing metal stent (ECE-LAMS) in patients with malignant biliary obstruction with failed\unfeasible ERCP and the adverse event (AE) rate. The secondary aims were to evaluate the technical success and incidence of jaundice recurrence. Data from All patients referred to our tertiary-care Institute with obstructive jaundice due to unresectable malignant distal biliary stricture and unfeasible\failed ERCP, were prospectively recorded from January 2015 to February 2018. The procedures were performed by a single-step ECE-LAMS (AXIOS-EC, Boston Scientific) placement, from the upper gut lumen to the biliary tree, for definitive biliary decompression. Twenty-one patients were consecutively enrolled. Mean pre-procedure common bile duct diameter was 16 mm and the bilirubin level was 13.9 mg/dL (range 3.8-29.5). LAMS was positioned from the duodenal bulb (n = 19) to gastric antrum (n = 2). We registered a 100 % of technical and clinical success. No AEs occurred. We observed a single case of delayed AE consisting of a buried LAMS, which was successfully resolved endoscopically. Despite the limits of being non-comparative, our study shows outcomes in a homogeneous population in terms of indications and technique. EUS-BD with dedicated ECE-LAMS is associated with extremely good clinical efficacy and safety and can be considered as an alternative in cases of failed/unfeasible ERCP.
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http://dx.doi.org/10.1055/a-1313-6850DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834702PMC
February 2021

Patency of endoscopic ultrasound-guided gastroenterostomy in the treatment of malignant gastric outlet obstruction.

Endosc Int Open 2020 Sep 31;8(9):E1194-E1201. Epub 2020 Aug 31.

Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.

Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) with a lumen-apposing metal stent (LAMS) is a novel, minimally invasive technique in the palliative treatment of malignant gastric outlet obstruction (GOO). Several studies have demonstrated feasibility and safety of EUS-GE, but evidence on long-term durability is limited. The aim of this study was to evaluate patency of EUS-GE in treatment of malignant GOO. An international multicenter study was performed in seven centers in four European countries. Patients who underwent EUS-GE with a LAMS between March 2015 and March 2019 for palliative treatment of symptomatic malignant GOO were included retrospectively. Our main outcome was recurrent obstruction due to LAMS dysfunction; other outcomes of interest were technical success, clinical success, adverse events (AEs), and survival. A total of 45 patients (mean age 69.9 ± 12.3 years and 48.9 % male) were included. Median duration of follow-up was 59 days (interquartile range [IQR] 41-128). Recurrent obstruction occurred in two patients (6.1 %), after 33 and 283 days of follow-up. Technical success was achieved in 39 patients (86.7 %). Clinical success was achieved in 33 patients (73.3 %). AEs occurred in 12 patients (26.7 %), of which five were fatal. Median overall survival was 57 days (IQR 32-114). EUS-GE showed a low rate of recurrent obstruction. The relatively high number of fatal AEs underscores the importance of careful implementation of EUS-GE in clinical practice.
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http://dx.doi.org/10.1055/a-1214-5659DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458745PMC
September 2020

Endoscopic drainage in patients with malignant extrahepatic biliary obstruction: when and how.

Eur J Gastroenterol Hepatol 2020 10;32(10):1279-1283

Humanitas University; Pieve Emanuele (MI); Italy.

The question of when and how to drain a malignant biliary obstruction (MBO), both intrinsic or extrinsic, remains a controversial point among endoscopists. An important factor that influences the decision to drain an MBO or not is if the patient is a surgical candidate or not and, in the former case, if the patients must undergo neoadiuvant chemotherapy or not. Other questions arising during biliary drainage in MBO patients is which type of stent should be chosen, plastic or metal, and if endoscopic biliary sphincterotomy must be performed or not when a stent is placed. The present review attempts to answer these questions and summarizes the optimal approach toward patients with MBO based on the available evidence.
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http://dx.doi.org/10.1097/MEG.0000000000001752DOI Listing
October 2020

Multicentric Italian survey on daily practice for autoimmune pancreatitis: Clinical data, diagnosis, treatment, and evolution toward pancreatic insufficiency.

United European Gastroenterol J 2020 07 12;8(6):705-715. Epub 2020 May 12.

Pancreas Unit, Department of Gastroenterology, Sant'Orsola Polyclinic, Bologna, Italy.

Background: Autoimmune pancreatitis (AIP) is a rare, and relatively new, form of chronic pancreatitis. The management of AIP can vary considerably among different centres in daily clinical practice.

Objectives: The aim of this study is to present a picture of epidemiological, clinical characteristics, outcomes, and the real-life practice in terms of management in several academic and non-academic centres in Italy.

Methods: Data on the clinical presentation, diagnostic work-up, treatments, frequency of relapses, and long-term outcomes were retrospectively collected in a cohort of AIP patients diagnosed at 14 centres in Italy.

Results: One hundred and six patients were classified as type 1 AIP, 48 as type 2 AIP, and 19 as not otherwise specified. Epidemiological, clinical, radiological, and serological characteristics, and relapses were similar to those previously reported for different types of AIP. Endoscopic cytohistology was available in 46.2% of cases, and diagnostic for AIP in only 35.2%. Steroid trial to aid diagnosis was administered in 43.3% cases, and effective in 93.3%. Steroid therapy was used in 70.5% of cases, and effective in 92.6% of patients. Maintenance therapy with low dose of steroid (MST) was prescribed in 25.4% of cases at a mean dose of 5 (±1.4) mg/die, and median time of MST was 60 days. Immunosuppressive drugs were rarely used (10.9%), and rituximab in 1.7%. Faecal elastase-1 was evaluated in only 31.2% of patients, and was pathological in 59.2%.

Conclusions: In this cohort of AIP patients, diagnosis and classification for subtype was frequently possible, confirming the different characteristics of AIP1 and AIP2 previously reported. Nevertheless, we observed a low use of histology and steroid trial for a diagnosis of AIP. Steroid treatment was the most used therapy in our cohort. Immunosuppressants and rituximab were rarely used. The evaluation of exocrine pancreatic insufficiency is underemployed considering its high prevalence.
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http://dx.doi.org/10.1177/2050640620924302DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7437084PMC
July 2020

The safety and efficacy of a new 20-mm lumen apposing metal stent (lams) for the endoscopic treatment of pancreatic and peripancreatic fluid collections: a large international, multicenter study.

Surg Endosc 2021 04 22;35(4):1741-1748. Epub 2020 Apr 22.

Department of Surgical Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.

Background: Lumen apposing metal stent (LAMS) allows an easy access to peripancreatic fluid collections (PPFCs) and the possibility of performing direct endoscopic necrosectomy (DEN). The aim of our study was to evaluate the safety and efficacy of a new 20-mm LAMS in the management of PPFCs. This novel stent represents the largest diameter LAMS available on the market to date.

Methods: This is an international, multicenter retrospective study involving 20 centers. Consecutive patients who underwent EUS-guided PPFC drainage using a 20-mm LAMS were included. Primary outcomes were technical and clinical success. Secondary outcomes were rate and the severity of adverse events.

Results: A total 105 patients underwent PPFC drainage using the new 20-mm LAMS and 106 LAMS were placed. Technical success was 100% (106/106). 7/105 patients died due to causes not related to the stent. Clinical success was achieved in 92/98 patients (93.9%). Significant adverse events occurred in 8/98 patients (8.16%): 4 cases (4.08%) of bleeding, 3 cases (3.06%) of suprainfection, 1 case of gastric outlet obstruction.

Conclusions: This multicenter study demonstrated acceptable rates of technical and clinical success using a new 20-mm LAMS for PPFC, including walled-off pancreatic necrosis (WOPN). The results of our study suggest that a new 20-mm LAMS is non-inferior in terms of safety, efficacy, and adverse events as compared to smaller diameter LAMS in the management of PPFCs, including pancreatic psuedocysts (PP) and WOPN. Randomized controlled studies will be needed to determine the ideal size of LAMS need to achieve the greatest clinical benefit with the minimized risk exposure for this high-risk patient population.
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http://dx.doi.org/10.1007/s00464-020-07567-8DOI Listing
April 2021

Single-step EUS-guided jejunojejunostomy with a lumen-apposing metal stent as treatment for malignant afferent limb syndrome.

VideoGIE 2020 Apr 6;5(4):154-156. Epub 2020 Feb 6.

Endoscopy Service, Department of Diagnostic and Therapeutic Services, Istituto Mediterraneo per i Trapianti e Terapie ad alta Specializzazione, Palermo, Italy.

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http://dx.doi.org/10.1016/j.vgie.2019.12.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7125391PMC
April 2020

Correction: Pure cystic groove pancreatitis: endosonographic appearance.

Endoscopy 2019 Aug 28;51(8):C7. Epub 2020 Feb 28.

Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), Palermo, Italy.

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http://dx.doi.org/10.1055/a-1126-5092DOI Listing
August 2019

Solid pseudopapillary pancreatic tumor: improbable is not impossible.

Gastrointest Endosc 2020 07 25;92(1):218-220. Epub 2020 Feb 25.

Radiology Service, Department of Diagnostic and Therapeutic Services, Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione, Palermo, Italy.

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http://dx.doi.org/10.1016/j.gie.2020.02.024DOI Listing
July 2020

Thyroid ectopia of the liver: An unusual diagnosis with contrast-enhanced EUS (with video).

Endosc Ultrasound 2019 Nov-Dec;8(6):430-431

Endoscopy Service, Department of Diagnostic and Therapeutic Services, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS - ISMETT), Palermo, Italy.

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http://dx.doi.org/10.4103/eus.eus_71_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6927141PMC
December 2019

International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage.

Gastrointest Endosc 2020 03 20;91(3):574-583. Epub 2019 Nov 20.

Digestive Endoscopy Unit, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Italy.

Background And Aims: High rates of technical and clinical success were reported for lumen-apposing metal stent (LAMS) placement for peripancreatic fluid collection (PFC) drainage. However, data on the adverse event (AE) rates are heterogeneous. The aim of this study was to evaluate the incidence, severity, management, and risk factors of AEs related to the use of LAMSs for drainage of PFCs in a large cohort of patients.

Methods: This is a multicenter, international, retrospective review from 15 centers of all patients who underwent placement of LAMSs for the management of PFCs. A nested case-control study was conducted in patients with (case) or without (control) AEs.

Results: Three hundred thirty-three procedures in 328 patients were performed (5 patients treated with 2 LAMSs). Technical success was achieved in 321 patients (97.9%). Three hundred four patients were finally included in the study (7 excluded for lost to follow-up information; 10 excluded for deaths unrelated to LAMSs). The rate of clinical success was 89.5%. Seventy-nine LAMS-related AEs occurred in 74 of 304 patients (24.3%), after a mean time of 25.3 days (median, 18 days; interquartile range, 6-30) classified as 20 (25.3%) mild, 54 (68.4%) moderate, or 5 (6.3%) severe. On multivariable analysis compared with control subjects, cases were more likely to have walled-off necrosis (WON) versus pancreatic pseudocysts (odds ratio, 2.18; 95% confidence interval, 1.09-4.46; P = .028), whereas cases were less likely to have undergone tract (balloon) dilation (yes vs no; odds ratio, .47; 95% confidence interval, .22-.93; P = .034).

Conclusions: Data from this large international retrospective study confirm that the use of LAMSs for management of PFCs has excellent technical and good clinical success rates. The rate of AEs, however, is not negligible and should be carefully considered before using these stents for drainage of PFCs and in particular for WON. Further prospective studies are needed to confirm these findings. (Clinical trial registration number: NCT03544008.).
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http://dx.doi.org/10.1016/j.gie.2019.11.021DOI Listing
March 2020

Endoscopic management of post-surgical GI wall defects with the overstitch endosuturing system: a single-center experience.

Surg Endosc 2020 09 3;34(9):3805-3817. Epub 2019 Oct 3.

Digestive Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS - ISMETT, Via Tricomi 5, 90127, Palermo, Italy.

Background And Aims: Post-GI surgical wall defects are frequent and life-threatening complications, with limited literature regarding current treatment. This case series aims to assess the safety, feasibility, and outcomes of endoluminal therapy with the overstitch endoscopic suturing system (Apollo Endosurgery Inc, Austin).

Materials And Methods: All patients who underwent endoscopic suturing for post-surgical wall defect management at IRCCS-ISMETT Palermo from October 2017 until January 2019 were retrospectively enrolled. Stratification therapy was applied according to the clinical scenario, time from surgery to endoscopic intervention, and structural condition of the wall defect layers (tissue status and suture feasibility). The therapeutic endoscopic strategy was divided into three groups (A: pure endoscopic direct suture; B: combined therapy with endoscopic direct suture + FC-SEMS placement + anchoring; C: FC-SEMS placement + anchoring). Success was considered the resolution of symptoms and the presence of a regular intestinal transit after a period of 4-6 weeks.

Results: Twenty (20) patients (male/female 7/13; mean age 54 ± 13.43 years) were included in the study (group A: 9 patients, group B: 7 patients, group C: 4 patients). The types of operative procedures were bariatric (9/20), post-tracheostomy (3/20), post-operative GI surgery (8/20). The post-surgical defects were predominantly intermediate and chronic (24-72 h: 1/20; 3-30 days: 13/20; > 30 days: 6/20). The overall clinical success was 80% (17/20 patients), with a success of 94% (16/17 patients) when excluding the three cases of tracheo-esophageal fistula. No evidence of migration was detected. The only complication was short stenosis of the distal esophagus, present in 4 patients (19%) and successfully treated with a novel lumen-apposing metal stent.

Conclusions: In our experience, considering the absence of clear guidelines, the endoluminal approach with the overstich endoscopic suturing system is a valid alternative to conventional therapy, offering mini-invasiveness, and presenting promising opportunities in terms of technical feasibility and clinical efficacy.
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http://dx.doi.org/10.1007/s00464-019-07145-7DOI Listing
September 2020

Sequential multistenting protocol in biliary stenosis after liver transplantation: a prospective analysis.

Endoscopy 2019 12 2;51(12):1130-1135. Epub 2019 Aug 2.

Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS - ISMETT, Palermo, Italy.

Background: Biliary complications are a serious source of morbidity after orthotopic and living-related liver transplantation. Endoscopic retrograde cholangiography (ERC) is the gold standard for patients with duct-to-duct anastomosis because it allows a direct approach for interventional procedures. A retrospective study showed results of a sequential multistenting protocol, without stent removal/exchange, with promising results. We conducted a prospective analysis to assess the clinical success, recurrence rate, and adverse event rate related to this protocol.

Methods: From May 2012 to April 2018, all consecutive patients with a diagnosis of anastomotic stenosis following liver transplantation were enrolled in the study, and were followed for a period of at least 6 months after the last ERC. During the first ERC, a maximum number of plastic stents (10 Fr) were placed. In subsequent ERCs, scheduled every 3 months up to a maximum of 1 year, additional stents were inserted, as many as possible, without removing the previously placed stents.

Results: From May 2012 to May 2018, 87 patients were included in the study and treated with a sequential multistenting protocol. The mean number of stents placed was 3.7 (SD 1.0). Clinical success (stricture resolution and normalization of cholestasis) was achieved in 86 patients (98.9 %). Seven patients (8.0 %) developed complications. Recurrence was recorded in seven patients (8.0 %) after a mean of 992.7 days (SD 622.1).

Conclusions: This study represents the first prospective demonstration of the efficacy and safety of a sequential multistenting protocol. A key limitation of the study is the lack of a comparative group treated according to the traditional stent exchange approach.
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http://dx.doi.org/10.1055/a-0977-3158DOI Listing
December 2019

Multiple plastic versus fully covered metal stents for managing post-liver transplantation anastomotic biliary strictures: a meta-analysis of randomized controlled trials.

Ann Gastroenterol 2019 Jul-Aug;32(4):407-415. Epub 2019 Apr 13.

Division of Gastroenterology & Hepatology University of Utah, Salt Lake City, Utah, USA (Douglas G. Adler).

Background: Anastomotic biliary strictures (ABS) following liver transplantation (LT) are one of the most common complications, occurring in 4.5-32% of patients. Multiple plastic stenting (MPS) requires multiple sessions, with the associated risk, cost and patient discomfort. Fully covered self-expandable metal stents (FC-SEMS) have increasingly been used in this setting. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs), comparing the role of FC-SEMS and MPS in the treatment of ABS post-LT.

Methods: We conducted a bibliographic search using PubMed and EMBASE, aimed at identifying available RCTs that compared MPS to FC-SEMS in patients with ABS post LT from January 2000 to October 2017. Primary outcomes were ABS resolution and recurrence, while secondary outcomes were adverse events and number of procedures performed. Pooled estimates were calculated using random-effects models.

Results: Four RCTs (205 patients) were included. ABS resolution and recurrence did not differ significantly between the groups (odds ratio [OR] 1.05, 95% confidence interval [CI] 0.43-2.56, P=0.92; and OR 2.37, 95%CI 0.54-10.38, P=0.25). The same was true for adverse events (OR 0.91, 95%CI 0.84-3.48, P=0.86) and migration rate (OR 1.31, 95%CI 0.46-3.71, P=0.61). The mean number of endoscopic retrograde cholangiopancreatography procedures was lower for FC-SEMS (mean difference [MD] -2.08).

Conclusions: FC-SEMS and MPS had equal ABS resolution and recurrence, although there was a trend towards a higher recurrence rate in FC-SEMS that disappeared when trials with a shorter stent indwelling time were excluding. No difference was found in overall adverse events or migration rate.
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http://dx.doi.org/10.20524/aog.2019.0376DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6595920PMC
April 2019

The lumen-apposing metal stent (LAMS)-in-LAMS technique as an intraprocedural rescue treatment during endoscopic ultrasound-guided gastroenterostomy.

Endoscopy 2019 11 4;51(11):E331-E332. Epub 2019 Jun 4.

Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), Palermo, Italy.

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http://dx.doi.org/10.1055/a-0924-5408DOI Listing
November 2019

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

Endosc Ultrasound 2019 Jul-Aug;8(4):261-268

Unit of Gastroenterology and Digestive Endoscopy, AUSL Bologna, Bellaria-Maggiore Hospital, Bologna, Italy.

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.
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http://dx.doi.org/10.4103/eus.eus_14_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6714486PMC
May 2019

Pure cystic groove pancreatitis: endosonographic appearance.

Endoscopy 2019 08 2;51(8):E235-E236. Epub 2019 May 2.

Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), Palermo, Italy.

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http://dx.doi.org/10.1055/a-0889-7569DOI Listing
August 2019

EUS-FNB with or without on-site evaluation for the diagnosis of solid pancreatic lesions (FROSENOR): Protocol for a multicenter randomized non-inferiority trial.

Dig Liver Dis 2019 06 8;51(6):901-906. Epub 2019 Apr 8.

Digestive Endoscopy Unit, University Hospital A. Gemelli, IRCCS, Roma, Italy.

Background: Rapid on-site evaluation (ROSE) of cytological specimensacquired with EUS-guided fine needle aspiration (EUS-FNA) represents the most accurate available technique to reach a definitive diagnosis in patients with pancreatic solid masses. Recently, needles with high histological yield have been developed for EUS-guided fine needle biopsy (EUS-FNB), with which the need for ROSE can be potentially overcome.

Aims: The primary aim is to compare the diagnostic accuracy of EUS-FNB with or without ROSE. The main endpoint will be measured against the gold standard diagnosis (surgical pathology whenever available or diagnostic work-up in agreement with a clinical course of at least six months). Secondary endpoints include: (a) safety; (b) presence of tissue core; (c) quality of specimens; (d) time of the sampling procedure. Reliability of macroscopic on-site evaluation (MOSE) by endosonographers will be also assessed.

Methods: FROSENOR is an international randomized non-inferiority ongoing study at sixteen centers in four continents. Eight hundred patients will be randomized in two arms (EUS-FNB + ROSE vs. EUS-FNB alone) and outcomes compared. Sample size has been calculated in order to demonstrate the non-inferiority of FNB alone. Randomization and data collection will be performed online.

Discussion: This study will ascertain if ROSE is still needed when performing EUS-FNB of solid pancreatic lesions.
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http://dx.doi.org/10.1016/j.dld.2019.03.008DOI Listing
June 2019

An unusual case of postcholecystectomy syndrome.

Gastrointest Endosc 2019 07 19;90(1):162-164. Epub 2019 Mar 19.

Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT (Mediterranean Institute for Transplantation and Highly Specialized Therapies), Palermo, Italy.

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http://dx.doi.org/10.1016/j.gie.2019.03.008DOI Listing
July 2019

Erratum: Endoscopist's occupational dose evaluation related to correct wearing of dosimeter during X-ray-guided procedures.

Endosc Int Open 2019 03 20;7(3):C1. Epub 2019 Mar 20.

IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), Palermo, Italy - Endoscopy Service, Department of Diagnostic and Therapeutic Services, Palermo, Italy.

[This corrects the article DOI: 10.1055/a-0841-3350.].
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http://dx.doi.org/10.1055/a-0876-6448DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6426725PMC
March 2019

Success and safety of endoscopic treatments for concomitant biliary and duodenal malignant stenosis: A review of the literature.

World J Gastrointest Surg 2019 Feb;11(2):53-61

Humanitas Huniversity, Hunimed, Pieve Emanuele, Milano 20090, Italy.

Synchronous biliary and duodenal malignant obstruction is a challenging endoscopic scenario in patients affected with ampullary, peri-ampullary, and pancreatic head neoplasia. Surgical bypass is no longer the gold-standard therapy for these patients, as simultaneous endoscopic biliary and duodenal stenting is currently a feasible and widely used technique, with a high technical success in expert hands. In recent years, endoscopic ultrasonography (EUS) has evolved from a diagnostic to a therapeutic procedure, and is now increasingly used to guide biliary drainage, especially in cases of failed endoscopic retrograde cholangiopancreatography (ERCP). The advent of lumen-apposing metal stents (LAMS) has expanded EUS therapeutic options, and changed the management of synchronous bilioduodenal stenosis. The most recent literature regarding endoscopic treatments for synchronous biliary and duodenal malignant stenosis has been reviewed to determine the best endoscopic approach, also considering the advent of an interventional EUS approach using LAMS.
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http://dx.doi.org/10.4240/wjgs.v11.i2.53DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6397798PMC
February 2019

Endoscopist's occupational dose evaluation related to correct wearing of dosimeter during X-ray-guided procedures.

Endosc Int Open 2019 Mar 28;7(3):E367-E371. Epub 2019 Feb 28.

RCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), Palermo, Italy - Radiology Service, Department of Diagnostic and Therapeutic Services, Palermo, Italy.

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http://dx.doi.org/10.1055/a-0841-3350DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6395086PMC
March 2019

EUS-guided radiofrequency ablation of small pancreatic adenocarcinoma: a new therapeutic option for patients unfit for surgery.

VideoGIE 2019 Jan 13;4(1):29-31. Epub 2018 Nov 13.

Endoscopy Service, Department of Diagnostic and Therapeutic Services, Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione, Palermo, Italy.

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http://dx.doi.org/10.1016/j.vgie.2018.09.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6317486PMC
January 2019

Endo-therapies for biliary duct-to-duct anastomotic stricture after liver transplantation: Outcomes of a nationwide survey.

Liver Int 2019 07 22;39(7):1355-1362. Epub 2019 May 22.

Diagnostic and Therapeutic Endoscopy Unit, Foundation IRCCS Istituto Nazionale Tumori, Milan, Italy.

Background: The most appropriate endo-therapeutic approach to biliary anastomotic strictures is yet to be defined.

Aim: To retrospectively report on the endo-therapy of duct-to-duct anastomotic strictures during 2013 in Italy.

Methods: Data were collected from 16 Endoscopy Units at the Italian Liver Transplantation Centers (BASALT study group).

Results: Complete endo-therapy and follow-up data are available for 181 patients: 101 treated with plastic multistenting, 26 with fully covered self-expandable metal stenting and 54 with single stenting. Radiological success was achieved for 145 patients (80%), that is, 88% of plastic multistenting, 88% of self-expandable metal stenting and 61% of single stenting (P < 0.001 vs plastic multistenting; P < 0.05 vs self-expandable metal stenting). After first-line endo-therapy failure, the patients underwent a second-line endo-therapy with plastic multistenting for 25%, fully covered self-expandable metal stenting for 53% and single stenting for 22% of cases, and radiological success was achieved for 84%, that is, 100%, 85% and 63% with plastic multistenting, self-expandable metal stenting and single stenting (P < 0.05 vs plastic multistenting or self-expandable metal stenting) respectively. Procedure-related complications occurred in 7.8% of endoscopic retrograde cholangiopancreatographies. Overall, clinical success was achieved in 87% of patients after a median follow-up of 25 months.

Conclusion: Plastic multistenting is confirmed as the preferred first-line treatment, while fully covered self-expandable metal stenting as rescue option for biliary anastomotic strictures. Single stenting has sub-optimal results and should be abandoned.
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http://dx.doi.org/10.1111/liv.14010DOI Listing
July 2019

Bridge-to-surgery gallbladder drainage with a lumen-apposing metal stent in malignant distal biliary obstruction: a choice tailored for the surgeon.

Endoscopy 2019 01 7;51(1):94-95. Epub 2018 Nov 7.

Endoscopy Service, Department of Diagnostic and Therapeutic Services, Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione (IRCCS-ISMETT), Palermo, Italy.

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http://dx.doi.org/10.1055/a-0754-1847DOI Listing
January 2019
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