Endoscopic Submucosal Dissection for Subepithelial Tumor Treatment in the Upper Digestive Tract: A Western, Multicenter Study.

Background/Aims: Endoscopic submucosal dissection (ESD) has been proposed for removal of gastrointestinal subepithelial tumors (GI-SETs), but data are still scanty. This study aimed to report a case series from a western country. Patients and Methods: Data of patients with upper GI-SETs suitable for ESD removal observed in 4 centers were retrospectively reviewed. Before endoscopic procedure, the lesion was characterized by endosonographic evaluation, histology, and CT scan. The en bloc resection and the R0 resection rates were calculated, as well as incidence of complications, and the 1-year follow-up was reported. Results: Data of 84 patients with esophageal (N = 13), gastric (N = 61), and duodenal (N = 10) GI-SETs were collected. The mean diameter of lesions was 26 mm (range: 12-110 mm). There were 17 gastrointestinal stromal tumors, 12 neuroendocrine tumors, 35 leiomyomas, 18 lipomas, and 2 hamartomas. En bloc and R0 resection were achieved in 83 (98.8%) and in 80 (95.2%) patients, respectively. Overall, a complication occurred in 11 (13.1%) patients, including bleeding (N = 7) and perforation (N = 4). Endoscopic approach was successful in all bleedings, but 1 patient who required radiological embolization, and in 2 perforations, while surgery was performed in the other patients. Overall, a surgical approach was eventually needed in 5 (5.9%), including 3 in whom R0 resection failed and 2 with perforation. Conclusions: Our study found that ESD may be an effective and safe alternative to surgical intervention for both benign and localized malignant GI-SETs.

Introdução/objetivos: A dissecção endoscópica da submucosa (ESD) tem sido proposta para a exérese de tumores subepiteliais gastrointestinais (GI-SETs), embora a literatura seja escassa. Este estudo teve como objetivo reportar uma série de casos de um país ocidental. Métodos: Coorte retrospectiva incluindo doentes com SETs do tubo digestivo superior submetidos a ESD em 4 centros (1 ano de follow-up). Antes do procedimento, a lesão foi caracterizada por ecoendoscopia, histologia e tomografia computadorizada. Foram avaliadas as taxas de ressecção em bloco e R0, bem como a incidência de complicações. Resultados: Incluídos 84 doentes com GI-SETs esofágicos (N = 13), gástricos (N = 61) e duodenais (N = 10). O diâmetro médio das lesões foi de 26 mm (intervalo 12­110 mm) ­ 17 tumores do estroma gastrointestinal, 12 tumores neuroendócrinos, 35 leiomiomas, 18 lipomas e 2 hamartomas. A resseção foi em bloco e R0 em 83 (98.8%) e em 80 (95.2%) doentes, respectivamente. Globalmente, ocorreram complicações em 11 (13.1%) doentes, incluindo hemorragia (N = 7) e perfuração (N = 4). A terapêutica endoscópica foi eficaz em todas as hemorragias exceto em 1 doente que necessitou de embolização radiológica e em 2 perfurações (submetidas a cirurgia). No geral, a abordagem cirúrgica foi necessária em 5 (5.9%) ­ 3 doentes com resseção R1 e 2 com perfuração. Conclusões: A ESD pode ser uma alternativa eficaz e segura à intervenção cirúrgica para GI-SETs benignos e malignos localizados.

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

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

Palliation of malignant esophageal obstruction using an anti-migration self-expandable metal stent: Results of a prospective multicenter study.

BACKGROUND: Self-expanding metal stents (SEMS) placement is primarily indicated to palliate dysphagia for patients with expected short-term survival. We aimed to assess the migration rate and other stent-related adverse events (AEs) of a fully covered SEMS with an anti-migration system (FCSEMS-AMS) for palliation of malignant dysphagia. METHODS: This is a prospective study including patients with inoperable esophageal cancer that received a FCSEMS-AMS (Taewoong, Niti-S Beta™), in five tertiary-care endoscopic centers from January 2014 to February 2016. RESULTS: Fifty-three consecutive patients were enrolled. Tumor location was proximal, mid and distal esophagus±esophago-gastric junction (EGJ) in 6, 14, and 33 cases, respectively. Overall, non-severe AEs were reported in 18 patients (34.0%), 13 of them required an additional endoscopic procedure. Migration occurred in 7 patients (13.2%): 3 from the upper and 4 from the lower esophagus and EGJ. Stent retrieval was necessary in one patient due to intolerable pain. Food bolus impaction and tumor overgrowth occurred in 2 patients (3.8%) and 4 (7.5%) patients respectively. Four patients complained of gastroesophageal reflux as late AEs. Median follow-up was 19.3 months. Dysphagia significantly improved until 3 and 6 months from stent insertion (median score before FCSEMS-AMS: 3, vs median score: 1). Median dysphagia-free time was 10 months. CONCLUSIONS: Placement of the Taewoong, Niti-S Beta™ stent appeared to be a safe and effective treatment of malignant dysphagia. The anti-migration system reduced the overall migration rate, although it remained high in strictures located in the upper esophagus and when the stent was placed across the EGJ.

Dilation assisted stone extraction for complex biliary lithiasis: Technical aspects and practical principles.

Common bile duct stones are frequently diagnosed worldwide and are one of the main indications for endoscopic retrograde cholangio-pancreatography. Endoscopic sphincterotomy (EST) has been used for the removal of bile duct stones for the past 40 years, providing a wide opening to allow extraction. Up to 15% of patients present with complicated choledocholithiasis. In this context, additional therapeutic approaches have been proposed such as endoscopic mechanical lithotripsy, intraductal or extracorporeal lithotripsy, or endoscopic papillary large balloon dilation (EPLBD). EPLBD combined with EST was introduced in 2003 to facilitate the passage of large or multiple bile duct stones using a balloon greater than 12 mm in diameter. EPLBD without EST was introduced as a simplified technique in 2009. Dilation-assisted stone extraction (DASE) is the combination of two techniques: EPLBD and sub-maximal EST. Several studies have reported this technique as safe and effective in patients with large bile duct stones, without any increased risk of adverse events such as pancreatitis, bleeding, or perforation. Nevertheless, it is difficult to analyze the outcomes of DASE because there are no standard techniques and definitions between studies. The purpose of this paper is to provide technical guidance and specific information about the main issues regarding DASE, based on current literature and daily clinical experience in biliary referral centers.

COVID-19 and the Gastrointestinal System: Lesions Beyond the Symptoms?

The outbreak of the COVID-19 pandemic has radically changed the daily hospital care activity for all medical specialists. Although the predominant symptoms of this new coronavirus infection are respiratory, the gastrointestinal tract is also significantly involved. In this short report, we will discuss a new and unexpected clinical presentation related to COVID-19 colonization of upper gastrointestinal tract.

Endoscopic Submucosal Dissection of Gastric Neoplastic Lesions: An Italian, Multicenter Study.

Endoscopic submucosal dissection (ESD) allows removing neoplastic lesions on gastric mucosa, including early gastric cancer (EGC) and dysplasia. Data on ESD from Western countries are still scanty. We report results of ESD procedures performed in Italy. Data of consecutive patients who underwent ESD for gastric neoplastic removal were analyzed. The en bloc resection rate and the R0 resection rates for all neoplastic lesions were calculated, as well as the curative rate (i.e., no need for surgical treatment) for EGC. The incidence of complications, the one-month mortality, and the recurrence rate at one-year follow-up were computed. A total of 296 patients with 299 gastric lesions (80 EGC) were treated. The en bloc resection was successful for 292 (97.6%) and the R0 was achieved in 266 (89%) out of all lesions. In the EGC group, the ESD was eventually curative in 72.5% (58/80) following procedure. A complication occurred in 30 (10.1%) patients. Endoscopic treatment was successful in all 3 perforations, whereas it failed in 2 out of 27 bleeding patients who were treated with radiological embolization (1 case) or surgery (1 case). No procedure-related deaths at one-month follow-up were observed. Lesion recurrence occurred in 16 (6.2%) patients (6 EGC and 10 dysplasia). In conclusion, the rate of both en bloc and R0 gastric lesions removal was very high in Italy. However, the curative rate for EGC needs to be improved. Complications were acceptably low and amenable at endoscopy.

Over-the-scope clip vs epinephrine with clip for first-line hemostasis in non-variceal upper gastrointestinal bleeding: a propensity score match analysis.

Background and study aims The over-the-scope clip (OTSC) is a novel tool used to improve the maintenance of hemostasis for non-variceal upper gastrointestinal bleeding (NVUGIB); however, studies on the comparison with "conventional" techniques are lacking. In this study, we aimed to compare first-line endoscopic hemostasis achieved using conventional techniques with that achieved using OTSC placement for NVUGIB. Patients and methods From January 2007 to March 2018, 793 consecutive patients underwent upper endoscopy with the hemostasis procedure. Among them, 327 patients were eligible for inclusion (112 patients had OTSC placement and 215 underwent conventional hemostasis). After propensity score matching and adjustment for confounding factors, 84 patients were stratified into the "conventional" group and 84 into the OTSC group. Patient characteristics and outcomes (rebleeding rate, mortality rate within 30 days, and adverse events) were compared between the two groups. Results In the unmatched cohort, hemostasis with OTSC was more frequent in cases of duodenal ulcers with Forrest Ia to IIa and in patients with a higher Rockall score compared with the "conventional group". In the matched cohort, 93 % of the patients in the "conventional group" underwent hemostasis with epinephrine + through-the-scope clip. Rebleeding events were significantly less frequent in the OTSC group (8 % vs 20 %, 95 %CI 3 - 16 vs 12 - 30; P  = 0.02); however, the mortality rate in the two groups was not significantly different (6 % vs 2 %, 95 %CI 1 - 8 vs 2 - 13; P  = 0.4). Conclusions OTSC is a safe and effective tool for achieving hemostasis, and we recommend its use as the first-line therapy for lesions with a high risk of rebleeding and in patients with a high risk Rockall score.

Endoscopic submucosal dissection: Italian national survey on current practices, training and outcomes.

BACKGROUND AND AIMS: Most of the evidence supporting endoscopic submucosal dissection (ESD) comes from Asia. European data are primarily reported by specialized referral centers and thus may not be representative of common European ESD practice. The aim of this study is to understand the current state of ESD practice across Italian endoscopy centers. METHODS: All Italian endoscopists who were known to perform ESD were invited to complete a structured questionnaire including: operator features and competencies, ESD training details and clinical outcomes over a 2-year period. RESULTS: Twenty-nine operators from 23 centers (69% response rate) completed the questionnaire: 18 (62%) were <50 years old; 7 (24%) were female; 16 (70%) were located in Northern Italy. Overall ESD volume was <40 cases in 9 (31%) operators, 40-80 in 8 (27.5%), 80-150 in 4 (13.8%) and >150 in 8 (27.5%). Colorectal ESD was predominant for operators with an experience >80 cases. En-bloc resection rates ranged from 77.2 to 97.2% depending on the anatomic location with an R0 resection rate range of 75.3-93.6%. ESD perforation rates in the colon and rectum were significantly lower when experience was >150 compared to 80-150 cases (p < 0.0001 and p = 0.006 for colon and rectum, respectively). CONCLUSION: ESD in Italy is performed by a significant number of operators. Overall, Italian endoscopists performing ESD have achieved a good competence level. However, there is much variability in training protocols, initial supervision of procedures, practice settings, case mix and procedural volume/year that are likely responsible for some of the suboptimal resectional outcomes and increased perforation risk, mainly in the colon. Standardized training programs, practice parameters and auditing of outcomes are required.

First-line endoscopic treatment with over-the-scope clips in patients with either upper or lower gastrointestinal bleeding: a multicenter study.

Background and study aims Endoscopic treatment is the mainstay approach for gastrointestinal bleeding, in either upper (UGIB) or lower (LGIB) tract. The over-the-scope clip (OTSC) may overcome limitations of standard clips or thermocoagulation in high-risk bleeding lesions. We evaluate the main clinically relevant outcomes following endoscopic hemostasis with OTSC in high-risk lesions and/or patients. Patients and methods This was a retrospective analysis of prospectively collected databases including all patients with UGIB and LGIB who underwent OTCS placement as first-line treatment in eleven tertiary endoscopic referral centers. Technical success, primary hemostasis, rebleeding, blood transfusion, hospital stay, and hemorrhage-related mortality rates were evaluated. Results Data from 286 patients, with either UGIB (N = 214) or LGIB (N = 72) were available. Overall, 112 patients (39.2 %) were receiving antithrombotic therapy. Technical success and primary hemostasis rates were 97.9 % and 96.4 %, respectively. Early rebleeding occurred in 4.4 %, more frequently in those on antithrombotic therapy, and no late rebleeding was observed. Following a successful primary haemostasis, only 5.2 % patients needed blood transfusions, and the median hospital stay was 4 days (range: 3 - 11). Eighteen patients with either technical failure (N = 6) or rebleeding (N = 12) underwent radiological or surgical approaches. Overall, bleeding-related deaths occurred in 5 (1.7 %) patients, including 3 patients with technical procedural failure, and 2 in the rebleeding group.  Conclusions Data from our large, multicenter study show that OTSC placement is an effective first-line treatment for hemostasis in high-risk patients and/or lesions both in upper and lower gastrointestinal tract.

Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study.

BACKGROUND AND AIMS: Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstructions. We aimed to compare stent patency, the adverse events rate, and overall survival of covered versus uncovered self-conformable metal stents in patients with primary malignant extrahepatic biliary strictures, not eligible for surgery. METHODS: This is a multicenter randomized trial analyzing 158 patients with inoperable distal malignant biliary obstruction conducted in 5 Italian referral centers between December 2014 and October 2016. Seventy-eight patients were randomized to receive a fully covered SEMS (FCSEMS), and 80 patients received uncovered SEMSs (USEMSs). Data from 148 (72 FCSEMSs and 76 USEMSs) of 158 patients were analyzed. RESULTS: Median time of stent patency was lower for FCSEMSs (240 days vs 541 days for USEMSs; P = .031). Adverse events occurred with 19 FCSEMSs (26.4%) and 10 USEMSs (13.2%); P = .061. The main causes of FCSEMS dysfunction were migration (7% vs 0% in the USEMS group) and early occlusion mainly because of sludge or overgrowth; late stent occlusion because of tumor ingrowth occurred in 13.2% of patients in the USEMS group. There were no significant differences either in levels of conjugated bilirubin improvement or in overall survival between the FCSEMS and USEMS groups. Median survival was 134 days in the FCSEMS group and 112 days in the USEMS group (P = .23). CONCLUSION: The number of stent-related adverse events was higher, although not significantly, among patients in the FCSEMS group. FCSEMSs had a significantly higher rate of migration than USEMSs, and stent occlusion occurred earlier. A significant difference in the patency rate was observed in favor of the USEMS group. (Clinical trial registration number: NCT02102984.).

Colonic Postpolypectomy Bleeding Is Related to Polyp Size and Heparin Use.

BACKGROUND/AIMS: We studied factors influencing colon postpolypectomy bleeding (PPB), with a focus on antithrombotic and anticoagulation therapy. METHODS: We conducted a retrospective case-control study of all patients who underwent polypectomy at our tertiary referral center in Italy between 2007 and 2014. Polyp characteristics (number of polyps removed per patient, size, morphology, location, resection technique, prophylactic hemostasis methods) and patient characteristics (age, sex, comorbidities, medication) were analyzed. RESULTS: The case and control groups included 118 and 539 patients, respectively. The two groups differed in the frequency of comorbidities (69% vs. 40%, p=0.001), polyps removed (27% vs. 18%, p=0.02), and use of heparin therapy (23% vs. 1%, p<0.001). A total of 279 polyps in the case group and 966 in the control group were nonpedunculated (69% vs. 81%, p=0.01) and measured ≥10 mm (78% vs. 32%, p=0.001). Multivariate analysis showed that polyps ≥10 mm (odds ratio [OR], 6.1; 95% confidence interval [CI], 2.3-15.5), administration of heparin (OR, 16.5; 95% CI, 6.2-44), comorbidity (OR, 2.3; 95% CI, 1.4-3.9), and presence of ≥2 risk factors (OR, 3.2; 95% CI, 1.7-6.0) were associated with PPB. CONCLUSIONS: The incidence of PPB increases with polyp size ≥10 mm, heparin use, comorbidity, and presence of ≥2 risk factors.

Over-the-scope clip closure for treatment of post-pancreaticogastrostomy pancreatic fistula: A case series.

BACKGROUND AND AIM: The over-the-scope clip (OTSC) system is a recently developed endoscopic device. In the last few years, it has been successfully used for severe bleeding or deep wall lesions, or perforations of the gastrointestinal (GI) tract. We hereby report a series of patients with post-pancreaticogastrostomy pancreatic fistula in whom OTSC were used as endoscopic treatment. METHODS: From January 2012 to July 2015, we prospectively collected data on cases of postoperative pancreatic fistula. These patients underwent pancreaticoduodenectomy in a high-volume center of hepatobiliopancreatic surgery. After conservative management, OTSC closure was done by single skilled operators in anesthesiologist-assisted deep sedation. RESULTS: A total of seven patients were enrolled. According to the International Study Group of Pancreatic Surgery criteria, we observed grade B postoperative pancreatic fistula in all cases. All patients were treated with 12/6 t-type OTSC. In two cases, a second clip was successfully applied to a second site adjacent to the original closure site. In all cases, subsequent fluoroscopy showed no contrastographic spreading through the wall. There were no complications related to the procedure itself, not from the endoscopy point of view, nor from the anesthesiological perspective. There were no device malfunctions. Further clinical and endoscopic evaluation was made 8 weeks later and showed no fistula or anastomotic defect recurrence. No patients required additional endoscopic or interventional procedures. CONCLUSION: In consideration of clinical and technical success, OTSC placement in POPF seems to be effective, safe and technically relatively easy to carry out.

Over-the-scope clips in the treatment of gastrointestinal tract iatrogenic perforation: A multicenter retrospective study and a classification of gastrointestinal tract perforations.

AIM: To determine the outcome of the management of iatrogenic gastrointestinal tract perforations treated by over-the-scope clip (OTSC) placement. METHODS: We retrospectively enrolled 20 patients (13 female and 7 male; mean age: 70.6 ± 9.8 years) in eight high-volume tertiary referral centers with upper or lower iatrogenic gastrointestinal tract perforation treated by OTSC placement. Gastrointestinal tract perforation could be with oval-shape or with round-shape. Oval-shape perforations were closed by OTSC only by suction and the round-shape by the "twin-grasper" plus suction. RESULTS: Main perforation diameter was 10.1 ± 4.3 mm (range 3-18 mm). The technical success rate was 100% (20/20 patients) and the clinical success rate was 90% (18/20 patients). Two patients (10%) who did not have complete sealing of the defect underwent surgery. Based upon our observations we propose two types of perforation: Round-shape "type-1 perforation" and oval-shape "type-2 perforation". Eight (40%) out of the 20 patients had a type-1 perforation and 12 patients a type-2 (60%). CONCLUSION: OTSC placement should be attempted after perforation occurring during diagnostic or therapeutic endoscopy. A failed closure attempt does not impair subsequent surgical treatment.