EUS-Guided Gallbladder Drainage Using a Lumen-Apposing Metal Stent for Acute Cholecystitis: Results of a Nationwide Study with Long-Term Follow-Up.

BACKGROUND: Although endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using lumen-apposing metal stents (LAMS) has become one of the treatments of choice for acute cholecystitis (AC) in fragile patients, scant data are available on real-life settings and long-term outcomes. METHODS: We performed a multicenter retrospective study including EUS-guided GBD using LAMS for AC in 19 Italian centers from June 2014 to July 2020. The primary outcomes were technical and clinical success, and the secondary outcomes were the rate of adverse events (AE) and long-term follow-up. RESULTS: In total, 116 patients (48.3% female) were included, with a mean age of 82.7 ± 11 years. LAMS were placed, transgastric in 44.8% of cases, transduodenal in 53.3% and transjejunal in 1.7%, in patients with altered anatomy. Technical success was achieved in 94% and clinical success in 87.1% of cases. The mean follow-up was 309 days. AEs occurred in 12/116 pts (10.3%); 8/12 were intraprocedural, while 1 was classified as early (<15 days) and 3 as delayed (>15 days). According to the ASGE lexicon, two (16.7%) were mild, three (25%) were moderate, and seven (58.3%) were severe. No fatal AEs occurred. In subgroup analysis of 40 patients with a follow-up longer than one year, no recurrence of AC was observed. CONCLUSIONS: EUS-GBD had high technical and clinical success rates, despite the non-negligible rate of AEs, thus representing an effective treatment option for fragile patients.

EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience.

BACKGROUND AND AIMS: EUS-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMSs) has been reported as a rescue treatment with encouraging results for the relief of jaundice in patients with distal malignant biliary obstruction (DMBO) and after failure of both ERCP and EUS-guided choledochoduodenostomy. METHODS: This was a multicenter retrospective analysis of all cases of consecutive EUS-GBD with LAMSs used as a rescue treatment for patients with DMBO in 14 Italian centers from June 2015 to June 2020. Primary endpoints were technical and clinical success, whereas the secondary endpoint was the adverse event (AE) rate. RESULTS: Forty-eight patients (52.1% women) with a mean age of 74.3 ± 11.7 years were included in the study. Biliary stricture was related to pancreatic adenocarcinoma (85.4%), duodenal adenocarcinoma (2.1%), cholangiocarcinoma (4.2%), ampullary cancer (2.1%), colon cancer (4.2%), and metastatic breast cancer (2.1%). The mean diameter of the common bile duct was 13.3 ± 2.8 mm. LAMSs were placed transgastrically in 58.3% of cases and transduodenally in 41.7%. Technical success was 100%, whereas clinical success was 81.3%, with a mean total bilirubin reduction after 2 weeks of 66.5%. The mean procedure time was 26.4 minutes, and the mean hospital stay was 9.2 ± 8.2 days. AEs occurred in 5 patients (10.4%): 3 were classified as intraprocedural and 2 were classified as delayed because they occurred after >15 days. When the American Society for Gastrointestinal Endoscopy lexicon was used, 2 AEs were mild and 3 were moderate (2 buried LAMSs). The mean follow-up was 122 days. CONCLUSIONS: Our study shows that EUS-GBD with LAMSs used as a rescue treatment for patients affected by DMBO represents a valuable option in terms of technical and clinical success rates, with an acceptable AE rate. To the best of our knowledge, this is the largest study concerning the use of this procedure. (Clinical trial registration number: NCT03903523.).

Endoscopic Findings in Patients Infected With 2019 Novel Coronavirus in Lombardy, Italy.

Coronavirus disease 2019 (COVID-19) is a major worldwide threat caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), rapidly spreading to a global pandemic. As of May 11, 2020, 4,176,346 cases have been reported worldwide, 219,814 in Italy, and of them, 81,871 occurred in the Lombardy region.1 Although the respiratory manifestations of COVID-19 have been widely described, the impact on the gastrointestinal (GI) system remains less clear. The reported prevalence of digestive symptoms ranges from 3% to 79%, depending on the setting,2-5 but data on GI endoscopic and histologic findings in COVID-19 patients are lacking. Therefore, the aim of this study is to describe the GI endoscopic and histologic findings in COVID-19 patients.

Complications and early mortality in percutaneous endoscopic gastrostomy placement in lombardy: A multicenter prospective cohort study.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) is the most common endoscopic procedure used to provide nutritional support. AIM: To prospectively evaluate the mortality and complication incidences after PEG insertion or replacement. METHODS: All patients who underwent PEG insertion or replacement were included. Details on patient characteristics, ongoing therapies, comorbidities, and indication for PEG placement/replacement were collected, along with informed consent form signatures. Early and late (30-day) complications and mortality were assessed. RESULTS: 950 patients (47.1% male) were enrolled in 25 centers in Lombardy, a region of Northern Italy. Patient mean age was 73 years. 69.5% of patients had ASA status 3 or 4. First PEG placement was performed in 594 patients. Complication and mortality incidences were 4.8% and 5.2%, respectively. The most frequent complication was infection (50%), followed by bleeding (32.1%), tube dislodgment (14.3%), and buried bumper syndrome (3.6%). At multivariable analysis, age (OR 1.08 per 1-year increase, 95% CI, 1.0-1.16, p = 0.010) and BMI (OR 0.86 per 1-point increase, 95% CI, 0.77-0.96, p = 0.014) were factors associated with mortality. PEG replacement was carried out in 356 patients. Thirty-day mortality was 1.8%, while complications occurred in 1.7% of patients. CONCLUSIONS: Our data confirm that PEG placement is a safe procedure. Mortality was not related to the procedure itself, confirming that careful patient selection is warranted.

First clinical experiences with a novel endoscopic over-the-scope clip system.

We describe our experience with a new over-the-scope clip (OTSC) system (Padlock Clip?) in the treatment of 14 patients. Eight of the 14 patients were treated for closure of gastrointestinal fistulas (n?=?4), iatrogenic gastrointestinal perforations (n?=?2), or hemostasis of post-polypectomy bleeding (n?=?2). The site of clipping was the lower gastrointestinal tract in five patients and the upper gastrointestinal tract in three patients. The clip was successfully delivered in seven out of the eight patients and clinical success was achieved in all patients. Endoscopic full thickness resection (EFTR) was performed to treat six patients: four with recurrent adenoma (n?=?4), one with ulcerated nodules at ileorectal anastomosis, and one with a neuro-endocrine tumor of the rectum. A complete intestinal wall resection was achieved in three of the six patients (50?%) and an R0 resection in five of the six patients (83.3?%). No complications related to the procedure and no recurrence at endoscopic follow-up were observed in any patient. The novel Padlock Clip seems to be an effective and safe tool to treat gastrointestinal fistulas, perforations or post-polypectomy bleeding, and to perform EFTR.

A prospective evaluation of short-term and long-term results from colonic stenting for palliation or as a bridge to elective operation versus immediate surgery for large-bowel obstruction.

BACKGROUND: The efficacy and safety of self-expandable metallic stent (SEMS) placement as a bridge to elective surgery or definitive palliation versus emergency operation to treat colorectal obstruction is debated. This study aimed to evaluate the outcomes of patients with colorectal obstruction treated using different strategies. METHODS: Subjects admitted to the authors' department with colorectal obstruction (n = 134) were studied prospectively. They underwent endoscopic stenting as a bridge to elective surgery (SEMS group: n = 49) or for definitive palliation (n = 34). A total of 51 patients underwent immediate surgery without stenting (NO-SEMS). Treatment was decided by the senior on-call surgeon. RESULTS: Placement of SEMS was technically successful in 95.3 % and clinically successful in 98.7 % of cases. The short-term complications in the SEMS group were perforation (n = 1, 1.2 %), migration (n = 4, 4.9 %), occlusion (n = 4, 4.9 %), colon bleeding (n = 3, 3.7 %), and abdominal pain (n = 6, 7.4 %). The postoperative complication rate was 32.7 % in the SEMS group versus 60.8 % in the NO-SEMS group (P = 0.005), with a significant reduction in wound infections (26.5 vs 54.9 %; P = 0.004), abdominal abscess (14.3 vs 39.2 %; P = 0.006), respiratory morbidity (10.2 vs 37.3 %; P = 0.002), and intensive care treatment (10.2 vs 33.3 %; P = 0.007). The median postoperative hospital stay was 10 versus 15 days (P = 0.001). The in-hospital mortality rate in both groups was 2 %. Long-term follow-up evaluation showed less incisional hernia (6.3 vs 22.0 %; P = 0.04) and definitive stoma formation (6.3 vs 26.0 %; P = 0.01) in the SEMS group than in the NO-SEMS group, respectively. Kaplan-Meier survival curves showed a benefit for the SEMS group (log-rank test, 0.004). The long-term SEMS-related complication rate for the palliative patients was 43.8 %. The hospital readmission rate for SEMS complications was 34.4 %. Overall clinical success was 81.2 %. CONCLUSIONS: In case of colorectal obstruction, endoscopic colon stenting as a bridge to elective operation should be considered as the treatment of choice for resectable patients given the significant advantages for short- and long-term outcomes. Palliative stenting is effective but associated with a high rate of long-term complications.

Fibrosis is associated with adiponectin resistance in chronic hepatitis C virus infection.

BACKGROUND: Chronic hepatitis C virus (HCV) infection is frequently associated with insulin resistance which has been suggested to promote fibrotic progression. Adiponectin, an adipocyte-derived insulin-sensitizing hormone, might play a protective role against hepatic fibrosis. MATERIALS AND METHODS: This observational case-control study investigated the adiponectin status in insulin resistant, nondiabetic, chronic HCV-infected patients (n=54; 13 women, 41 men) compared with age-, sex- and BMI-matched healthy controls. Liver biopsies from patients with chronic HCV hepatitis were analysed for the adiponectin and adiponectin receptors (ADIPOR) 1 and 2 mRNA and protein expressions. RESULTS: Serum adiponectin levels were higher in patients with chronic HCV hepatitis than in healthy controls (12·1±4·7 vs. 9·5±4·4 mg L(-1) in men, P = 0·01; 18·2±4·4 vs. 13·6±5·3mgL(-1) in women, P=0·02). BMI, HDL cholesterol and triglycerides levels correlated with adiponectin levels both in patients and in controls, while no correlation with glucose, insulin and HOMA-IR values could be detected. Nonetheless, insulin resistance was predictive of steatosis and fibrosis in chronic HCV-infected patients. Interestingly, patients with none or mild fibrosis showed serum adiponectin levels similar to those in healthy controls, while hyperadiponectinemia was associated with moderate to severe stages of fibrosis. Hyperadiponectinemia was unlikely sustained by liver production as hepatocytes did not express the protein. ADIPOR1 mRNA, but not ADIPOR2 levels, was reduced in chronic HCV hepatitis. The reduced ADIPOR1 expression was confirmed by immunohistochemistry. CONCLUSIONS: In patients with chronic HCV hepatitis, fibrosis was associated with hyperadiponectinemia. Chronic HCV-infected hepatocytes showed reduced ADIPOR1 expression, suggesting a pattern of adiponectin resistance.

Sustained virologic response prevents the development of esophageal varices in compensated, Child-Pugh class A hepatitis C virus-induced cirrhosis. A 12-year prospective follow-up study.

UNLABELLED: The incidence of de novo development of esophageal varices (EV) in patients with compensated liver cirrhosis has been determined by few studies in the short term and never in the long term. The aims of the present study were to determine the incidence and the risk factors associated with the development of EV and to assess whether antiviral treatment and achievement of sustained virologic response (SVR) may prevent de novo EV development in patients with HCV-induced cirrhosis. We studied 218 patients with compensated EV-free, HCV-induced cirrhosis consecutively enrolled between 1989 and 1992 at three referral centers in Milan, Italy. Endoscopic surveillance was performed at 3-year intervals according to international guidelines. SVR was defined as undetectable serum HCV-RNA 24 weeks after treatment discontinuation. During a median follow-up of 11.4 years, 149/218 (68%) patients received antiviral treatment and 34 (22.8%) achieved SVR. None of the SVR patients developed EV compared with 22 (31.8%) of the 69 untreated subjects (P < 0.0001) and 45 (39.1%) of the 115 non-SVR patients (P < 0.0001). On multivariate analysis, HCV genotype 1b (hazard ratio [HR] 2.40; 95% confidence interval [CI] 1.17-4.90) and baseline model for end-stage liver disease (MELD) score (HR 1.20; 95% CI 1.07-1.35 for 1 point increase) were independent predictors of EV. CONCLUSION: In the long term, the achievement of SVR prevents the development of EV in patients with compensated HCV-induced cirrhosis. Therefore, in these patients, endoscopic surveillance can be safely delayed or avoided. Genotype 1b infection and MELD score identify the subset of patients at higher risk of EV development who need tailored endoscopic surveillance.

Predicting mortality risk in patients with compensated HCV-induced cirrhosis: a long-term prospective study.

OBJECTIVES: The identification of prognostic factors associated with mortality is crucial in any clinical setting. METHODS: We enrolled in a prospective study 352 patients with compensated hepatitis C virus (HCV)-induced cirrhosis, consecutively observed between 1989 and 1992. At entry, patients underwent upper endoscopy to detect esophageal varices, and were then surveilled by serial clinical and ultrasonographic examination. The model for end-stage liver disease (MELD) score was calculated with information collected at enrollment. Baseline predictors and intercurrent events associated with mortality were assessed using the Cox regression model. RESULTS: During a median follow-up of 14.4 years, 194 subjects received a single course of interferon monotherapy, 131 patients developed decompensation (ascites, bleeding, hepatic encephalopathy), 109 patients had hepatocellular carcinoma (HCC), 9 had liver transplant, and 158 died. Esophageal varices were associated with development of decompensation (hazard ratio (HR), 2.09; 95% confidence interval (CI), 1.33-3.30) and liver-related death (HR, 2.27; 95% CI, 1.41-3.66). A MELD score of > 10 predicted overall mortality (HR, 2.15; 95% CI, 1.50-3.09). Overall survival of patients with MELD < or = 10 was 80% at 10 years. HCC occurrence increased the risk of decompensation fivefold (HR, 5.52; 95% CI, 3.77-8.09). Hepatic and overall mortality hazard ratios were 8.62 (95% CI, 5.57-13.3) and 3.80 (95% CI, 2.67-5.42), respectively, for patients who developed HCC, and 16.9 (95% CI, 9.97-28.6) and 7.08 (95% CI, 4.88-10.2) for those who experienced decompensation. CONCLUSIONS: In patients with compensated HCV-induced cirrhosis, the presence of esophageal varices at baseline predicted decompensation and mortality. The development of HCC during follow-up strongly hastens the occurrence of decompensation, which is the main determinant of death. Patients with a MELD score < or = 10 at study entry had a prolonged life expectancy.

Iron accumulation in chronic hepatitis C: relation of hepatic iron distribution, HFE genotype, and disease course.

The aim of the present study was to describe the histopathologic features of hepatic iron accumulation in patients with chronic hepatitis C (CH-C) infection, the relation between HFE mutations and hepatic iron location and among iron distribution, HFE, and hepatic damage. We studied 206 patients with CH-C infection. Of 101 patients with hemosiderin deposits, 90.1% had iron deposits in hepatocytes (alone or with sinusoidal and/or portal involvement). The hepatic iron score increased significantly as iron accumulation involved sinusoidal and portal tract compartments and according to HFE genotypes. Severe fibrosis and cirrhosis were associated more markedly with the presence of hemosiderin iron in the 3 hepatic compartments, HFE mutations, and high alcohol intake. We suggest that part of the iron accumulation in CH-C infection derives from increased iron absorption and release from storage cells and that the amount and distribution of hepatic iron deposits is related to hepatic damage. HFE mutations favor both processes, but other factors, genetic or acquired, are involved.