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

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.

Low molecular weight heparin does not increase bleeding and mortality post-endoscopic variceal band ligation in cirrhotic patients.

BACKGROUND & AIMS: Anticoagulants are commonly indicated in cirrhotic patients due to high rate of (pro)thrombotic conditions. Low molecular weight heparin (LMWH) is safe in patients with esophageal varices. However, the safety of LMWH is unknown in patients undergoing prophylactic endoscopic variceal ligation (EVL). To define the 4-week risk of bleeding and death after prophylactic EVL in cirrhotic patients continuously treated with LMWH. METHODS: All EVLs performed at a tertiary Italian Center from 2009 to 2016 were retrospectively reviewed. Patients treated with LMWH were classified as on-LMWH; the remaining as no-LMWH. Endoscopic characteristics at first and index EVL (that preceding an endoscopy either showing a bleeding episode or the absence of further treatable varices) and clinical events within 4 weeks from the procedures were recorded. RESULTS AND CONCLUSIONS: Five hundred fifty-three EVLs were performed in 265 patients (in 215 as a primary prophylaxis): 169 EVLs in 80 on-LMWH and 384 in 185 no-LMWH (4.9 ± 1.1 vs 4.8 ± 1.0 bands/session, respectively; P = .796). Six patients bled (2.2%) without between-groups difference (3.8% on-LMWH vs 1.6% no-LMWH, Log-rank P = .291). Large varices with red marks (100% vs 51.4%, P = .032), number of bands (5.6 ± 0.5 vs 4.6 ± 1.2, P = .004), underlying portal vein thrombosis (66.7% vs 23.6%, P = .033), and creatinine (2.2 ± 2.7 vs 1.0 ± 0.8 mg/dL, P = .001) at index EVL were significantly different between bleeders and non-bleeders. Six patients died within 4-week from index EVL, without between-groups difference (2.5% on-LMWH vs 2.2% no-LMWH, Log-rank P = .863). LMWH does not increase the risk of post-procedural bleeding and does not affect survival of cirrhotic patients undergoing prophylactic EVL.

Anesthesiologist-directed care for elective gastrointestinal endoscopy: results of an Italian multicentric prospective observational study.

BACKGROUND: Sedation, ranging from minimal, moderate and deep sedation to general anesthesia, improves patient comfort and procedure quality in gastrointestinal endoscopy (GIE). There are currently no comprehensive recommendations on sedation practice in diagnostic and therapeutic GIE. We aimed to investigate real-life sedation practice in elective GIE. METHODS: We performed a multicentric observational study across 14 Endoscopy Units in Italy. We recorded consecutive data on all diagnostic procedures performed with Anesthesiologist-directed care (ADC) and all therapeutic procedures performed with ADC or non-Anesthesiologist sedation (NAS) over a three-month period. RESULTS: Dedicated ADC is available five days/week in 28.6% (4/14), four days/week in 21.5% (3/14), three days/week in 35.7% (5/14), two days/week in 7.1% (1/14) and one day/week in 7.1% (1/14) of participating Centers. ADC use for elective diagnostic GIE varied from 18.2% to 75.1% of the total number of procedures performed with ADC among different Centers. ADC use for elective therapeutic GIE varied from 10.8% to 98.9% of the total number of elective therapeutic procedures performed among different Centers. CONCLUSIONS: Our study highlights the lack of standardization and consequent great variability in sedation practice for elective GIE, with ADC being potentially overused for diagnostic procedures and underused for complex therapeutic procedures. A collaborative effort involving Endoscopists, Anesthesiologist and Institutions is needed to optimize sedation practice in GIE.

Efficacy and safety of capsule endoscopy in octogenarian patients: a retrospective study.

BACKGROUND: Life expectancy and the number of ultra-octogenarians increased significantly, thus making crucial the appropriateness of several endoscopic procedures in elderly patients. The aim of our study was to provide a retrospective analysis of the efficacy and safety of capsule endoscopy (CE) in patients aged over 80 years. METHODS: In this single-centre study, 900 patients underwent capsule endoscopy between 2002 and 2015 for different indications; of these 106 patients aged ≥80 years (group A) and 99 patients aged 40-60 years (control group B) were retrospectively selected. RESULTS: Occult gastrointestinal bleeding accounted for 62.1% of all indications for capsule endoscopy in group B, compared to 95.2% in group A (P<0.001). Although not statistically significant, the diagnostic yield was higher in group A (71%) vs. group B (62%). The percentages of reaching the cecum and the median gastric transit time were uniform within the two groups. In contrast, small bowel transit time was longer in group A vs. B. Small bowel preparation was similar in the two groups. The exam was generally well tolerated in both groups, with capsule aspiration being one of the main adverse events, which occurred in two elderly patients. CONCLUSIONS: Our data expand previous findings confirming that capsule endoscopy can be performed safely even in very old patients and show that the diagnostic yield is similar to that of younger patients.

Right-sided diverticulosis is an independent risk factor for bleeding in patients admitted for diverticular disease.

BACKGROUND: Diverticular bleeding is the main cause of lower gastrointestinal bleeding in both Eastern and Western countries. Several risk factors have been identified, such as comorbidities and concomitant medications. In Eastern population, the prevalence of right-side diverticulosis is higher than in Western one, and some Authors identified bilateral diverticulosis as a risk factor for bleeding. AIMS: To identify risk factors for diverticular bleeding in patients admitted for diverticular disease (DD). METHODS: All patients admitted for DD from January 2017 to December 2018 were retrieved from the hospital Information System. For each patient, age, gender, clinical presentation and concomitant medication were recorded. All patient underwent imaging assessment (computed tomography, ultrasound or MRI) and colonoscopy during hospitalization or within one month. RESULTS: Among 1248 patients discharged with a diagnosis of DD during the study period, 293 (52.2% male, median age 75 years) were finally analyzed; of them, 105 (35.8%) for diverticular bleeding. On multivariate analysis, male gender (OR 4.27), age (OR 1.12), anti-thrombotic medications (OR 2.60) and right-sided DD (OR 5.70) were independently correlated to diverticular bleeding. CONCLUSION: Our study provides evidence that, together with age, male gender and concomitant anti-thrombotic treatment, right-sided DD represents an independent risk factor for bleeding.

Combined Endoscopic Stent-In-Stent Placement by Lumen-Apposing Metal Stents Through Self-Expanding Metal Stents for Simultaneous Malignant Biliary and Duodenal Obstruction.

The palliation of simultaneous biliary and duodenal obstruction in patients with advanced pancreatic cancer is a clinically and technically challenging scenario. Endoscopic procedures are a valid alternative to surgical or percutaneous transhepatic biliary drainage. The availability of self-expanding metal stents (SEMSs) and lumen-apposing metal stents (LAMS) have expanded therapeutic options. We describe a case in which biliary and duodenal obstructions were treated successfully with the combined use of SEMS and LAMS devices. Endoscopic ultrasound-guided biliary drainage with the use of new LAMS and a duodenal SEMS can be a valid option in expert hands as a palliative and minimally invasive treatment for gastric outlet and biliary obstruction.

Accreditation program for gastrointestinal endoscopes reprocessing in Italy: An on-site survey.

Background and study aims Endoscope reprocessing has been associated with a variable failure rate. Our aim was to present an overview on current practices for reprocessing in Italian facilities and discuss the principle critical points. Methods In 2014 the Italian Society for Digestive Diseases implemented an accreditation program in collaboration with an independent organization for certification and with the Italian Association for Endoscopy Technical Operators. During a 1-day site visit of the endoscopy center, two endoscopists, one nurse, and the representative of the certification body evaluated the endoscope reprocessing. Results As of July 1, 2020, 28 endoscopy centers had been accredited. Ten centers are completing the measures to correct deficiencies found at the visit. Three centers withdrew from the program. The accreditation program has found variations between the various centers, confirming the poor compliance with guidelines. Major deviations from the standards, established by the model before the site visit according to national and international guidelines, concerned instrument cleaning (44.7 % of the centers), instrument storage (23.7 %), and microbiological tests (31.6 %). Conclusions Our overview demonstrated the lack of many reprocessing phases, which are important to prevent endoscopy-associated infections. Accreditation can achieve a transformation in quality and safety of reprocessing with the Italian centrally-led approach.

Symptomatic response to GERDOFF® in patients with gastro-esophageal reflux disease and poor response to alginates: an exploratory, post-market, open-label study.

BACKGROUND/AIMS: A novel medical device based on hyaluronic acid, chondroitin sulphate plus aluminum hydroxide (GERDOFF®, melt-in-mouth tablets) showed efficacy in reducing GER-related symptoms. This exploratory, open-label study evaluated symptomatic effects of a 14-day treatment with GERDOFF® in GERD patients. MATERIALS AND METHODS: GERD Impact Scale (GIS) questionnaire was filled at baseline visit, after 7 and 14 days of treatment; patients' Global Satisfaction was evaluated at the final visit. Primary endpoint was the reduction of heartburn episodes per week; secondary endpoints were GERD-related symptoms, patients' satisfaction, and safety. RESULTS: Forty patients were included, 22 were on stable therapy with proton pump inhibitor (PPI). Compared to baseline, the days with heartburn episodes and the GIS score progressively decreased during the first (p<0.0001) and the second week of treatment (p<0.0001). Heartburn episodes per week (p<0.0001) and the GIS score (p<0.0001) decreased in the first and the last 7 days of 14-day treatment and did not differ between patients on and off PPI. The treatment was safe and well-tolerated, and it was rated as very good (46.2%) or good (43.6%) on the satisfaction questionnaire. CONCLUSION: GERDOFF® could effectively treat GER symptoms in patients not responding to PPI or alginate-based formulation. ISRCTN_15143752.

The Italian Society for Digestive Endoscopy (SIED) accreditation and quality improving project based on international standards.

Background and study aims Accreditation of endoscopy services, using valid quality indicators, may address failures to comply with quality standards between endoscopy services. The aim of this work was to present the Italian Society for Digestive Endoscopy (SIED) accreditation model and its effectiveness. Methods A team of eight endoscopists identified quality indicators derived from international guidelines and assessed them in each center voluntarily requesting accreditation. During a 1-day site visit, two expert endoscopists, the representative of the independent and international administrative certification body and a professional nurse evaluated the endoscopy center, by direct observation of the endoscopy team and examination of the medical records Results In all centers we noted shortcomings in instrument reprocessing. In 30 of 40 centers (75 %) the information in the nursing charts was incomplete. Sampling for Helicobacter pylori had not been done in 12 of 40 centers (30 %). In six of 40 centers (15 %) the adenoma detection rate for each endoscopist had not been evaluated. Post-polypectomy intervals were inappropriate in 12 of 40 centers (30 %). We noted a statistically significant difference ( P  < 0.001) between the answers to the SIED checklist of indicators submitted to the inspection team for accreditation before the site visit and the situation found for colonoscopy on site. As of June 30, 2018, 18 endoscopy centers had been accredited and 10 centers had not yet being accredited because they had not completed the measures to correct points raised at the visits. Conclusions Numerous Italian endoscopy centers fail to meet important quality indicators. Our accreditation program can provide means for detecting these problems and correcting them by implementing SIED standards.

Myeloperoxidase-positive cell infiltration in colorectal carcinogenesis as indicator of colorectal cancer risk.

Colorectal mucosa is targeted by toxic agents, which can initiate or promote colon cancer. The mechanism of damage might be a focal irritation with loss of normal epithelial cell barrier function. Genetic alterations in tumors may also affect host inflammatory response. The aim of this study was to define the extent of inflammation in colorectal mucosa, along colorectal carcinogenesis, and in microsatellite stable and unstable colorectal carcinomas. We collected 103 samples of normal colorectal mucosa from 65 patients (35 with colorectal cancer or adenoma, 8 with inflammatory bowel diseases, and 22 controls with normal colonoscopy). We also examined 24 aberrant crypt foci, 14 hyperplastic polyps, 16 adenomas, and 67 samples of colorectal carcinoma. Immunohistochemistry was used to count myeloperoxidase (MPO)-positive cells (neutrophils and monocytes) in x100 optical fields under a light microscope. Patients with colorectal tumors had a higher mean number of MPO-positive cells in normal mucosa than controls (mean +/- SD, 2.7 +/- 2.0 versus 1.4 +/- 1.4; P = 0.017). MPO-positive cell number was tightly linked to dysplasia in aberrant crypt foci and adenomas, and it was higher in carcinomas microsatellite unstable than those microsatellite stable (21.6 +/- 15.5 versus 11.9 +/- 8.0; P < 0.01). MPO immunohistochemistry is a simple and reliable technique for the quantification of inflammation in colorectal mucosa., and it may be a potential marker of colorectal cancer risk. Microsatellite instability seems to influence host immune responses to colorectal carcinoma. These observations strongly support a key role of inflammation in colorectal carcinogenesis.

A hyaluronic acid- and chondroitin sulfate-based medical device improves gastritis pain, discomfort, and endoscopic features.

Gastritis is an inflammation of the gastric mucosa. In this study, we investigated the efficacy of a medical device, Esoxx®, based on hyaluronic acid and chondroitin sulfate on gastritis-related upper abdominal pain/discomfort and endoscopic features. Fifty patients, affected by gastritis, were randomised to receive the medical device or placebo. The primary endpoint was the medical device efficacy on upper abdominal pain/discomfort associated with gastritis and measured by Visual Analogue Scale (VAS). The secondary endpoints were the efficacy of the medical device on gastritis-related mucosal erosions, blood oozing, and hyperemia (redness)/edema, as assessed by endoscopy, and the patients' rating of their compliance with the treatments. A significant reduction in VAS pain was observed in the treatment group after a 5-week treatment, if compared with placebo (p < 0.001). In summary, administration of a medical device, based on hyaluronic acid and chondroitin sulfate, improves gastritis-related upper abdominal pain/discomfort and decreases mucosal erosions, blood oozing, and hyperemia (redness)/edema at 5-week follow-up in patients affected by gastritis.

Efficacy of a Novel Granulocyte Monocyte Apheresis Adsorber Device in the Treatment of Inflammatory Bowel Diseases: A Pilot Study.

Granulocyte monocyte apheresis (GMA) is a non-pharmacological treatment for inflammatory bowel disease. In our study, we tested a novel GMA adsorber device in terms of clinical efficacy and safety in patients' non-response to pharmacological therapy. Secondary outcomes were the evaluation of adsorber's technical performance, the reduction of inflammatory markers and the improvement of patients' life quality. The prospective study included 18 patients enrolled from 2011 to 2012 with a monitoring of 48 weeks. All patients with Crohn's disease achieved a clinical remission after GMA treatments, sustained until the end of follow up, while 80% of ulcerative colitis patients obtained a clinical benefit, maintained after 48 weeks of monitoring. Leukocytes, neutrophils, monocytes and platelets, compared to erythrocytes and lymphocytes, were effectively removed from peripheral blood. There was no statistically significant result about serological markers of inflammation. A consistent improvement of the patients' quality of life was observed up to the end of follow up. No significant side-effects were recorded. Our study underlines the efficacy and the safety of this novel GMA adsorber device; a prospective randomized clinical trial with adequate sample size should be performed.

Cytomegalovirus and Clostridium Difficile co-infection in severe ulcero-hemorrhagic colitis during induction chemotherapy for acute lymphoblastic leukemia.

Here we describe the first case of a biopsy-proven Cytomegalovirus ulcero-hemorrhagic colitis, associated with Clostridium Difficile co-infection, occurring during standard induction chemotherapy for common B cell acute lymphoblastic leukemia. We discuss the case and focalize clinical management and diagnostic issues arising from it.

An unusual case of familial adenomatous polyposis with very early symptom occurrence.

We report the clinical case of a patient who showed an "accelerated" form of polyposis, with development of major lesions within the first decade of life. The patient belongs to a familial adenomatous polyposis family-already described in 2001-featured by profuse polyposis at an early age of onset and desmoid tumors in the majority of affected individuals (of both sexes). The family was characterized by an uncommon mutation of the APC gene (c.4391_4700del310insCACCTACTGCTGAAA, previously defined as c.4394ins15del310) consisting in a large deletion of 310 bp at codon 1,464 with duplication of the breakpoint leading to a stop codon at position 1,575. The proband was affected by desmoids tumors at the age of 3 years. In the same year (2004) numerous polyps in the large bowel and a hepatoblastoma developed. After several months new desmoids appeared in the surgical scar. In 2010, at age 9, the patient was operated of total colectomy and endorectal pull-through of the small intestine owing to profuse colorectal adenomatosis. New desmoids developed in 2011 and 2012, and required chemotherapy. Further analysis of the APC gene in the proband revealed several polymorphisms. One of these (c.398A>G) had not been previously reported, nor was present in two other affected members of the family. The clinical case, and the practical implications for therapy, are discussed according to the most recent theories of colorectal cancer development. Long-term treatment with Cox-2 inhibitors might represent a good option for this patient.

Proposal of a new clinical index predictive of endoscopic severity in ulcerative colitis.

Assessment of disease activity by clinical parameters in ulcerative colitis is still controversial. Different clinical indexes have been proposed. Colonoscopy provides detailed information on mucosal damage. The aim of this study was to identify, among 21 clinical and laboratory parameters, which were predictive of endoscopic activity. We included 137 consecutive patients with ulcerative colitis who underwent colonoscopy, clinical examination, and blood tests within 4 weeks. Endoscopic severity was recorded using a simple score (range, 0-30). The multiple stepwise regression coefficient of each significant variable predictive of mucosal damage was used to develop a new activity index predictive of endoscopic appearance (Endoscopic-Clinical Correlation Index; ECCI). We tested the ability of our score to discriminate patients with severe endoscopic disease, calculating the area under the receiver operator characteristic curve, and we compared it to activity indexes proposed by other authors. Endoscopic severity was significantly influenced by four parameters: bloody stool, nocturnal bowel movements, body temperature >37.5 degrees C, and serum albumin. The new scoring system was calculated as ECCI = {[serum albumin x (-26)] + (bloody stool x 17) + (nocturnal bowel movements x 16) + [fever (0 or 1) x 39]} + 107. The ECCI accurately identified patients with severe endoscopic disease in our sample (sensitivity = 81%, specificity = 95%). In conclusion, the ECCI should be useful in clinical practice because it is simple and strongly related to endoscopic activity.