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OverStitch devices (OverStitch and OverStitch Sx; Apollo Endosurgery, Inc, Austin, Tex, USA) are used for a wide range of applications. A European registry was created to prospectively collect technical and clinical data regarding both systems to provide procedural outcomes and to find correlation between procedural characteristics and outcomes. This study shows the initial results of the first 3 years of the registry. Patients who underwent endoscopic suturing from January 2018 to January 2021 at 9 centers were enrolled. Data regarding the disease treated,suturing pattern and outcomes were registered. Technical feasibility (success reaching the target area), technical success (success placing sutures), and clinical success (complete resolution of the clinical issue) were recorded and analyzed. During the study period, 137 patients (57.7% men) were enrolled with 100% technical feasibility rate. Endoscopic suturing was successfully performed in 136 cases (16.7% with OverStitch Sx), obtaining a technical success rate of 99.3%. No adverse events were recorded. Overall clinical success was 89%. Mucosal defects were sutured in 32 patients (100% clinical success). Leaks/fistulas were treated in 23 patients (64.7% clinical success). The clinical success of stent fixations (n = 38) was 85%. Perforations (n = 22) were repaired with a clinical success of 94.7%. No significant correlation between location, suture pattern or number, and the success was found, except in case of fistulas where fistulas <1 cm treated by a continuous suture were more likely to achieve clinical success in the follow-up (P <.001). OverStitch-based suturing is technically feasible regardless of site and method of suturing, with no cases of failure. The overall technical success rate of 99.3% and the clinical outcome success rate of 89% demonstrate that OverStitch technology provides reliable suturing with clinical advantages, especially with fistulas <1 cm. [ABSTRACT FROM AUTHOR]

Exposed endoscopic full-thickness resection (Eo-EFTR) is emerging as a promising minimally invasive alternative to surgery for the treatment of deep gastric submucosal tumors (G-SMTs). However, literature concerning this subject is heterogeneous and data mostly come from relatively small retrospective studies. We aimed to perform a pooled analysis of published data with regard to gastric Eo-EFTR, providing a pooled estimate of technical and clinical outcomes. The protocol was registered in PROSPERO. MEDLINE and EMBASE databases were searched for studies published from 1998 to 2020. The primary outcomes were complete resection and surgical conversion rates. The secondary outcomes were overall and selected major adverse events rates. The Forest plots on primary and secondary endpoints were produced based on fixed and random effect models. Nineteen studies including 952 Eo-EFTR-treated G-SMTs were included. The pooled estimate of the complete resection rate and surgical conversion rates was 99.3% and 0.09%, respectively. The pooled estimate of overall major adverse events, delayed bleeding, delayed perforation and peritonitis, abdominal abscess and/or abdominal infection was 0.29%, 0.14%, 0.14%, and 0.12%, respectively. Gastric Eo-EFTR has a high rate of complete resection with a low surgical conversion rate. It appears to be relatively safe and might represent a non-inferior minimally invasive alternative to surgery in selected cases. [ABSTRACT FROM AUTHOR]

Abstract Despite the progress achieved by scientific research in recent years, pancreatic cystic lesions (PCLs) remain a challenging clinical problem. A significant percentage of benign PCLs are still wrongly sent to surgery, with all the related risks of a high number of surgery-related complications and mortality. Diagnosis of the type of PCL, and risk stratification for malignancy are essential for a correct management of these lesions. Several guidelines have identified some clinical and morphological aspects suggesting the need for more accurate exams. Endoscopic ultrasound fine needle aspiration (EUS-FNA) of cystic fluid for cytology is the advised method of tissue acquisition in several guidelines, and the most used technique around the world. However sensitivity and adequacy of this technique are limited by the low amount of cells dispersed in cystic fluid. Alternative techniques have been tested to target the cystic walls in an attempt to obtain microhistologic specimens in order to augment the probability of obtaining an adequate diagnostic sample. The aim of this review is to offer a critical overview of the existing literature on tissue acquisition in PCLs, and emphasize advantages and disadvantages of each technique, and unclear areas that need to be investigated with future research. [ABSTRACT FROM AUTHOR]

Background Hemospray is a new endoscopic haemostatic powder that can be used in the management of upper gastrointestinal bleedings. Aims To assess the efficacy and safety of Hemospray as monotherapy for the treatment of acute upper gastrointestinal bleeding due to cancer. Methods The endoscopy databases of 3 Italian Endoscopic Units were reviewed retrospectively and 15 patients (8 males; mean age 74 years) were included in this study. Results Immediate haemostasis was achieved in 93% of cases. Among the successful cases, 3 re-bled, one case treated with Hemospray and injection had a good outcome, while 2 cases died both re-treated with Hemospray, injection and thermal therapy. No complications related to Hemospray occurred. Finally, 80% of patients had a good clinical outcome at 30 days and 50% at six months. Conclusion Hemospray may be considered an effective and safe method for the endoscopic management of acute neoplastic upper gastrointestinal bleedings. [ABSTRACT FROM AUTHOR]

Background Endoscopic retrograde cholangio-pancreatography is the gold standard of treatment in patients with biliary complications after liver transplantation. The benefits of fully covered self-expandable metal stents (FCSEMS) lie in their relative simplicity and the need for only two procedures, one for insertion, and the other for removal. Several case series have been published on such stents with generally good outcomes. Objective is to analyze definitive long-term outcomes of this treatment. Methods Prospective, observational study in a single, tertiary-care referral centre. All consecutive patients with post-transplant biliary stenosis/leak were treated with FCSEMS after failure of conventional treatment. Recurrence was evaluated after four years. Results From February 2008 to April 2012, 70 patients were included. In all patients, the metal stent was successfully placed. After a mean of 86.7 ± 38.4 days, the stent was removed. Forty-six patients (65.7%) showed resolution. After a mean of 4 ± 1.2 years, 61% of patients maintained the results, but 39% showed recurrence. On the tested variables the diagnosis of stenosis, the number of previous procedures and plastic stents placed correlate with better long-term results. Conclusions This series suggests a lack of long-term advantages of FCSEMS over plastic stents in the management of biliary stenosis after liver transplantation. [ABSTRACT FROM AUTHOR]

Background Underwater EMR (UEMR) has been reported as a new technique for the removal of large sessile colorectal polyps without need for submucosal injection. Objective To evaluate (1) outcomes of UEMR, (2) whether UEMR can be easily performed by an endoscopist skilled in traditional EMR without specific dedicated training in UEMR, and (3) whether EUS is required before UEMR. Design Prospective, observational study. Setting Single, tertiary-care referral center. Intervention Underwater EMR. Main Outcome Measurements Complete resection and adverse events. Results A total of 72 consecutive patients underwent UEMR of 81 sessile colorectal polyps. EUS was performed before UEMR in 9 cases (11.1%) with a suspicious mucosal/vascular pattern. The mean polyp size was 18.7 mm (range 10–50 mm); the mean UEMR time was 11.8 minutes. Fifty-five polyps (68%) were removed en bloc, and 26 (32%) were removed with a piecemeal technique. Histopathology consisted of tubular adenomas (25.9%), tubulovillous adenomas (5%), adenomas with high-grade dysplasia (42%), serrated polyps (4.9%), carcinoma in situ (13.6%), and hyperplastic polyps (8.6%). Surveillance colonoscopy was scheduled at 3 months. Complete resection was successful in all patients. No adverse events or recurrence was recorded in any of the patients. Limitations Limited follow-up; single-center, uncontrolled study. Conclusion Interventional endoscopists skilled in conventional EMR performed UEMR without specific dedicated training. EUS may not be required for lesions with no invasive features on high-definition narrow-band imaging. UEMR appears to be an effective and safe alternative to traditional EMR and could eventually improve the way in which we can effectively and safely treat colorectal lesions. [ABSTRACT FROM AUTHOR]

Abstract: Background: Endoscopic ultrasound fine needle aspiration has a central role in the diagnostic algorithm of solid pancreatic masses. Data comparing the fine needle aspiration performed with different aspiration volume and without aspiration are lacking. We compared endoscopic ultrasound fine needle aspiration performed with the 22 gauge needle with different aspiration volumes (10, 20 and 0ml), for adequacy, diagnostic accuracy and complications. Methods: Prospective clinical study at four referral centres. Endoscopic ultrasound fine needle aspiration was performed with a 22G needle with both volume aspiration (10 and 20 cc) and without syringe, in randomly assigned sequence. The cyto-pathologist was blinded as to which aspiration was used for each specimen. Results: 100 patients met the inclusion criteria, 88 completed the study. The masses had a mean size of 32.21±11.24mm. Sample adequacy evaluated on site was 87.5% with 20ml aspiration vs. 76.1% with 10ml (p =0.051), and 45.4% without aspiration (20ml vs. 0ml p <0.001; 10ml vs. 0ml p <0.001). The diagnostic accuracy was significantly better with 20ml than with 10ml and 0ml (86.2% vs. 69.0% vs. 49.4% p <0.001). Conclusions: A significantly higher adequacy and accuracy were observed with the 20ml aspiration puncture, therefore performing all passes with this volume aspiration may improve the diagnostic power of fine needle aspiration. [Copyright &y& Elsevier]

Abstract: Background: Self-expandable metal stents are a non-surgical option for the treatment of symptomatic malignant colorectal obstruction as palliative treatment or as a bridge to surgery. Aims: To report data from a regional study on self-expandable metal stent (SEMS) placement for malignant colorectal obstruction. Methods: Two hundred and four patients (male 54.9%, mean age of 69.5±14.2) were retrospectively evaluated and data on technical and clinical success, and complications, were analyzed. Results: Technical and clinical success rates were 99% and 94.6% respectively, with 36.7% treated on an emergency basis and 63.3% electively. Palliative treatment was administered to 70.1%, and as a bridge to surgery for 29.9%. Complications were 17 neoplastic ingrowths, 10 stent migrations, and 4 perforations. Palliative treatment was associated with a higher risk of stent ingrowth (p =0.003), and chemotherapy with a lower risk of stent ingrowth (p =0.009). Conclusion: This regional study, although it has certain limitations, confirms the positive role of self-expandable metal stents in the treatment of symptomatic malignant colorectal obstruction, and that chemotherapy decreases the risk of ingrowth. [Copyright &y& Elsevier]

Abstract: Background: Cytologic diagnosis by endoscopic ultrasound-guided fine needle aspiration is associated with low sensitivity and adequacy. A newly designed endoscopic ultrasound-guided fine needle biopsy device, endowed with a side fenestration, is now available. Aims: We carried out a study with the aim of evaluating the feasibility, safety, and diagnostic yield of the 22-gauge needle with side fenestration for endoscopic ultrasound fine needle aspiration and biopsy of pancreatic cystic lesions. Methods: 58 patients with 60 pancreatic cystic lesions consecutively referred for endoscopic ultrasound guided-fine needle aspiration were enrolled in a prospective, dual centre study, and underwent fine needle aspiration and biopsy with the 22-gauge needle with side fenestration. Results: Fine needle aspiration and biopsy was technically feasible in all cases. In 39/60 (65%) pancreatic cystic lesions, the specimens were adequate for cyto-histologic assessment. In lesions with solid components, and in malignant lesions, adequacy was 94.4% (p =0.0149) and 100% (p =0.0069), respectively. Samples were adequate for histologic evaluation in 18/39 (46.1%) cases. There were only 2 (3.3%) mild complications. Conclusions: Fine needle aspiration and biopsy with the 22-gauge needle with side fenestration is feasible, and superior to conventional endoscopic ultrasound-guided fine needle aspiration cytology from cystic fluid, particularly in pancreatic cystic lesions with solid component or malignancy, with a higher diagnostic yield and with no increase in complication rate. [Copyright &y& Elsevier]

Abstract: Background: Endoscopic ultrasound-guided fine needle aspiration of pancreatic cystic lesions has been reported to have a higher complication rate than that of solid lesions, but the real complication rate is unknown. Aim of the study was to identify the complication rate of endoscopic ultrasound-guided fine needle aspiration and related risk factors. Methods: Prospective multicenter study at four referral centres. Data were collected from January 2010 to July 2012, searching for all adverse events related to guided fine needle aspiration. All complications occurring up to day 90 were recorded. Results: 298 patients (43.9% male, mean age 63.2±15.4 years) underwent endoscopic ultrasound-guided needle aspiration of pancreatic cystic lesions. Mean size was 34.1±9mm. Adverse events occurred in 18 patients (6%): mild complications in 12/18 (66.6%), and moderate complications in 6/18 (33.3%). Seven were immediate, 6 early, and 5 late. All resolved with medical therapy. Conclusions: Endoscopic ultrasound-guided fine needle aspiration of pancreatic cystic lesions has been found to be associated with a higher complication rate than for solid lesions; however, the risk rate is acceptable considering the complication grade and the important diagnostic role of the technique in the management of pancreatic cystic lesions. [Copyright &y& Elsevier]

Background: Brushing is the most commonly used technique for biliary sampling at ERCP, despite its limited sensitivity. Objective: To evaluate intraductal aspiration (IDA) as a new combined endoscopic technique for cytodiagnosis, its cellular adequacy, diagnostic accuracy for cancer detection, feasibility, and safety. Design: Prospective, observational study. Setting: Single tertiary referral center. Main Outcome Measurements: IDA cellular adequacy, diagnostic accuracy for cancer detection, feasibility, and safety. Patients and Methods: From April 2009 to September 2010, 42 consecutive patients with suspected malignant biliary stricture underwent ERCP, with tissue sampling obtained with IDA. IDA included performance of standard brushing in all patients. After standard brushing, to perform IDA, we removed the brush from its catheter and used the tip of the catheter as a scraping device. The tip was scraped back and forth across the stricture at least 10 times. The catheter and a suction line were connected to a specimen trap to obtain intraductal aspiration of fluids and samplings. Results: Our cytopathologists found adequate cellular yield in 39 of the 42 IDA samples (92.8%) versus 15 of the 42 brushing samples (35.7%) (P < .001). IDA showed a significantly higher sensitivity than brushing (89% vs 78% for adequate samples and 89% vs 37% for all samples) and provided significantly superior cellular adequacy (92.8% vs 35.7%). Limitations: Observational study, small number of patients. Conclusions: IDA significantly improves brushing cellular adequacy and has high sensitivity for cancer detection. It was also safe, simple, rapid, and applicable during routine diagnostic ERCP, with no additional costs. [Copyright &y& Elsevier]

Adequate bowel cleansing is critical to ensure quality and safety of a colonoscopy. A novel 1-L polyethylene glycol plus ascorbate (1L-PEG+ASC) regimen was previously validated against low-volume regimens but was never compared with high-volume regimens. In a phase IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4-L PEG-based regimen (4L-PEG) in 5 Italian centers. Preparation was assessed with the Boston Bowel Preparation Scale (BBPS) by local endoscopists and centralized reading, both blinded to the randomization arm. The primary endpoint was noninferiority of 1L-PEG+ASC in colon cleansing. Secondary endpoints were superiority of 1L-PEG+ASC, patient compliance, segmental colon cleansing, adenoma detection rate, tolerability, and safety. Three hundred eighty-eight patients (median age, 59.8 years) were randomized between January 2019 and October 2019: 195 to 1L-PEG+ASC and 193 to 4L-PEG. Noninferiority of 1L-PEG+ASC was demonstrated for cleansing in both the entire colon (BBPS ≥ 6: 97.9% vs 93%; relative risk [RR], 1.03; 95% confidence interval [CI], 1.001-1.04; P superiority =.027) and in the right-sided colon segment (98.4% vs 96.0%; RR, 1.02; 95% CI,.99-1.02; P noninferiority =.013). Compliance was higher with 1L-PEG+ASC than with 4L-PEG (178/192 [92.7%] vs 154/190 patients [81.1%]; RR, 1.10; 95% CI, 1.05-1.12), whereas no difference was found regarding safety (moderate/severe side effects: 20.8% vs 25.8%; P =.253). No difference in adenoma detection rate (38.8% vs 43.0%) was found. One-liter PEG+ASC showed noninferiority compared with 4L-PEG in achieving adequate colon cleansing and provided a higher patient compliance. No differences in tolerability and safety were detected. (Clinical trial registration number: NCT03742232.) [ABSTRACT FROM AUTHOR]

Abstract: Background: Fully covered self-expanding metal stents are now being used to treat benign biliary diseases. Aims: To assess the outcomes of these stents as first-step therapy in patients with biliary leaks secondary to hepato-biliary surgery. Methods: Thirty patients (56.7% males; mean age: 60.2±13 years) were retrospectively evaluated. The data collected included technical and clinical success, adverse events and follow-up findings (1, 3 and 6 months). Results: Technical and clinical success rates were 100%. One early mild post-procedure pancreatitis occurred and resolved spontaneously. Three late stent distal migrations occurred, however cholangiography showed correct leak sealing in all patients. Stents were removed after a mean of 55.9 days. During follow-up no other complications occurred. Conclusion: In our experience fully covered self-expanding metal stent placement was safe and efficacious as first-step therapy for post-operative biliary leaks. However, prospective comparative studies with plastic stents are required to validate these findings. [Copyright &y& Elsevier]