Migration rate using fully covered metal stent in anastomotic strictures after liver transplantation: Results from the BASALT study group.

BACKGROUND AND STUDY AIM: The traditional endoscopic therapy of anastomotic strictures (AS) after orthotopic liver transplantation (OLT) is multiple ERCPs with the insertion of an increasing number of plastic stents side-by-side. Fully covered self-expanding metal stents (cSEMS) could be a valuable option to decrease the number of procedures needed or non-responders to plastic stents. This study aims to retrospectively analyse the results of AS endoscopic treatment by cSEMS and to identify any factors associated with its success. PATIENTS AND METHODS: Ninety-one patients (mean age 55.9 ± 7.6 SD; 73 males) from nine Italian transplantation centres, had a cSEMS positioned for post-OLT-AS between 2007 and 2017. Forty-nine (54%) patients were treated with cSEMS as a second-line treatment. RESULTS: All the procedures were successfully performed without immediate complications. After ERCP, adverse events occurred in 11% of cases (2 moderate pancreatitis and 8 cholangitis). In 49 patients (54%), cSEMSs migrated. After cSEMS removal, 46 patients (51%) needed further endoscopic (45 patients) or radiological (1 patient) treatments to solve the AS. Lastly, seven patients underwent surgery. Multivariable stepwise logistic regression showed that cSEMS migration was the only factor associated with further treatments (OR 2.6, 95% CI 1.0-6.6; p value 0.03); cSEMS implantation before 12 months from OLT was associated with stent migration (OR 5.2, 95% CI 1.7-16.0; p value 0.004). CONCLUSIONS: cSEMS appears to be a safe tool to treat AS. cSEMS migration is the main limitation to its routinary implantation and needs to be prevented, probably with the use of new generation anti-migration stents.

Infection Control Practices and Outcomes of Endoscopy Units in the Lombardy Region of Italy: A Survey From the Italian Society of Digestive Endoscopy During COVID-19 Spread.

GOALS: The present survey from the Italian Society of Digestive Endoscopy (SIED-Società Italiana di Endoscopia Digestiva) was aimed at reporting infection control practice and outcomes at Digestive Endoscopy Units in a high-incidence area. BACKGROUND: Lombardy was the Italian region with the highest coronavirus disease-2019 (COVID-19) prevalence, at the end of March 2020 accounting for 20% of all worldwide deaths. Joint Gastro-Intestinal societies released recommendations for Endoscopy Units to reduce the risk of the contagion. However, there are few data from high-prevalence areas on adherence to these recommendations and on their efficacy. METHODS: A survey was designed by the Lombardy section of SIED to analyze (a) changes in activity and organization, (b) adherence to recommendations, (c) rate of health care professionals' (HCP) infection during the COVID-19 outbreak. RESULTS: In total, 35/61 invited centers (57.4%) participated; most modified activities were according to recommendations and had filtering face piece 2/filtering face piece 3 and water-repellent gowns available, but few had negative-pressure rooms or provided telephonic follow-up; 15% of HCPs called in sick and 6% had confirmed COVID-19. There was a trend (P=0.07) toward different confirmed COVID-19 rates among endoscopists (7.9%), nurses (6.6%), intermediate-care technicians (3.4%), and administrative personnel (2.2%). There was no correlation between the rate of sick HCPs and COVID-19 incidence in the provinces and personal protective equipment availability and use, whereas an inverse correlation with hospital volume was found. CONCLUSIONS: Adherence to recommendations was rather good, though a minority were able to follow all recommendations. Confirmed COVID-19 seemed higher among endoscopists and nurses, suggesting that activities in the endoscopy rooms are at considerable viral spread risk.

Plasma miRNA-based signatures in CRC screening programs.

Colorectal cancer (CRC) screening programs help diagnose cancer precursors and early cancers and help reduce CRC mortality. However, currently recommended tests, the fecal immunochemical test (FIT) and colonoscopy, have low uptake. There is therefore a pressing need for screening strategies that are minimally invasive and consequently more acceptable to patients, most likely blood based, to increase early CRC identification. MicroRNAs (miRNAs) released from cancer cells are detectable in plasma in a remarkably stable form, making them ideal cancer biomarkers. Using plasma samples from FIT-positive (FIT+) subjects in an Italian CRC screening program, we aimed to identify plasma circulating miRNAs that detect early CRC. miRNAs were initially investigated by quantitative real-time PCR in plasma from 60 FIT+ subjects undergoing colonoscopy at Fondazione IRCCS Istituto Nazionale dei Tumori, then tested on an internal validation cohort (IVC, 201 cases) and finally in a large multicenter prospective series (external validation cohort [EVC], 1121 cases). For each endoscopic lesion (low-grade adenoma [LgA], high-grade adenoma [HgA], cancer lesion [CL]), specific signatures were identified in the IVC and confirmed on the EVC. A two-miRNA-based signature for CL and six-miRNA signatures for LgA and HgA were selected. In a multivariate analysis including sex and age at blood collection, the areas under the receiver operating characteristic curve (95% confidence interval) of the signatures were 0.644 (0.607-0.682), 0.670 (0.626-0.714) and 0.682 (0.580-0.785) for LgA, HgA and CL, respectively. A miRNA-based test could be introduced into the FIT+ workflow of CRC screening programs so as to schedule colonoscopies only for subjects likely to benefit most.

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.

Hemospray application in nonvariceal upper gastrointestinal bleeding: results of the Survey to Evaluate the Application of Hemospray in the Luminal Tract.

BACKGROUND: Hemospray TM (TC-325) is a novel hemostatic agent licensed for use in nonvariceal upper gastrointestinal bleeding (NVUGIB) in Europe. GOALS: We present the operating characteristics and performance of TC-325 in the largest registry to date of patients presenting with NVUGIB in everyday clinical practice. METHODS: Prospective anonymized data of device performance and clinical outcomes were collected from 10 European centers using the multicentre SEAL survey (Survey to Evaluate the Application of Hemospray in the Luminal tract). TC-325 was used as a monotherapy or as second-line therapy in combination with other hemostatic modalities at the endoscopists' discretion. RESULTS: Sixty-three patients (44 men, 19 women), median age 69 (range, 21 to 98) years with NVUGIB requiring endoscopic hemostasis were treated with TC-325. There were 30 patients with bleeding ulcers and 33 with other NVUGIB pathology. Fifty-five (87%) were treated with TC-325 as monotherapy; 47 [85%; 95% confidence interval (CI), 76%-94%] of them achieved primary hemostasis, and rebleeding rate at 7 days was 15% (95% CI, 5%-25%). Primary hemostasis rate for TC-325 in patients with ulcer bleeds was 76% (95% CI, 59%-93%). Eight patients, who otherwise may have required either surgery or interventional radiology, were treated with TC-325 as second-line therapy after failure of other endoscopic treatments, all of whom achieved hemostasis following the adjunct of TC-325. CONCLUSIONS: This multicentre registry identifies potentially useful characteristics of Hemospray (TC-325) when used either as monotherapy or as a rescue therapy in a wide variety of ulcer and nonulcer NVUGIB.

Upper gastrointestinal active bleeding ulcers: review of literature on the results of endoscopic techniques and our experience with Hemospray.

INTRODUCTION AND OBJECTIVES: Acute gastrointestinal (GI) bleeding can lead from mild to immediately life-threatening clinical conditions. Upper GI bleeding (UGIB) is associated with a mortality of 6-10%. Spurting and oozing bleeding are associated with major risk of failure. Hemospray™ (TC-325), a new hemostatic powder, may be useful in these cases. Aim of this study is to review the efficacy of traditional endoscopic treatment in Forrest 1a-1b ulcers and to investigate the usefulness of Hemospray in these patients. PATIENTS AND METHODS: A MEDLINE search was performed and articles that evaluated hemostatic efficacy and rebleeding rate with traditional endoscopic techniques related to Forrest classification were reviewed. Patients with Forrest 1a-1b ulcers were treated with Hemospray, either as monotherapy or in association with other endoscopic techniques. Primary outcome was immediate hemostasis, secondary outcomes were recurrent bleeding and adverse events related to Hemospray use. RESULTS: Analysis of literature showed that mean initial hemostasis success rate in Forrest 1a-1b ulcers was of 92.8%, and mean rebleeding rate was of 13.3%. We enrolled 13 patients treated with Hemospray. Initial hemostasis was achieved in 100% and we reported three cases of rebleeding. No adverse events occurred. CONCLUSION: Forrest 1a-1b bleeding ulcer is very difficult to treat. Hemospray appears to be an effective hemostatic therapy for these ulcers. However, additional prospective studies are needed to validate these findings.

Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute GI bleeding after failure of conventional techniques.

BACKGROUND: Through-the-scope clips are commonly used for endoscopic hemostasis of gastrointestinal (GI) bleeding, but their efficacy can be suboptimal in patients with complex bleeding lesions. The over-the-scope clip (OTSC) could overcome the limitations of through-the-scope clips by allowing compression of larger amounts of tissue, allowing a more efficient hemostasis. We analyzed the use of OTSC in a consecutive case series of patients with acute GI bleeding unresponsive to conventional endoscopic treatment modalities. METHODS: In a retrospective analysis of prospectively collected data in tertiary referral centers, patients undergoing emergency endoscopy for severe acute nonvariceal GI bleeding were treated with the OTSC after failure of conventional techniques. All patients underwent repeat endoscopy 2-4 days after the procedure. Data analysis included primary hemostasis, complications, and 1-month follow-up clinical outcome. RESULTS: During a 10-month period, 30 patients entered the study consecutively. Bleeding lesions unresponsive to conventional endoscopic treatment (saline/adrenaline injection and through-the-scope clipping) were located in the upper and lower GI tract in 23 and 7 cases, respectively. Primary hemostasis was achieved in 29 of 30 cases (97 %). One patient with bleeding from duodenal bulb ulcer required emergent selective radiological embolization. Rebleeding occurred in two patients 12 and 24 h after the procedure; they were successfully treated with conventional saline/adrenaline endoscopic injection. CONCLUSIONS: OTSC is an effective and safe therapeutic option for severe acute GI bleeding when conventional endoscopic treatment modalities fail.

Hood colonoscopy in trainees: a useful adjunct to improve the performance.

BACKGROUND: The use of a transparent hood to improve colonoscopic performance has recently been proposed. AIMS: The purpose of this study was to evaluate whether using the hood might improve the cecal intubation rate, cecal intubation time, number of attempts needed to intubate the ileo-cecal valve, and polyp detection rate in trainees. METHODS: Patients undergoing colonoscopy (n = 378) were randomized in two groups, one studied with hood colonoscopy (n = 179) and the other (n = 199) with standard examination. RESULTS: No differences were found between hood and standard colonoscopy with respect to cecal intubation rate (95 vs 92 %), whereas hood colonoscopy significantly shortened the cecal intubation time, the number of attempts needed to intubate the ileo-cecal valve, and the overall polyp detection rate (p < 0.01 for all these variables). CONCLUSIONS: Hood colonoscopy might represent a useful adjunct to standard colonoscopy, especially improving the performance of endoscopic trainees.

Endosonographic evaluation of the mediastinum through the i-gel O2 supraglottic airway device.

INTRODUCTION: Endobronchial ultrasound (EBUS) is an endoscopic diagnostic procedure combining flexible fibrobronchoscopy with ultrasound techniques; it allows transbronchial needle aspiration biopsy for the diagnosis and staging of mediastinal masses. We present our preliminary experience with the use of the i-gel O2 supraglottic airway device for management of EBUS procedures. METHODS: An observational study on 39 patients who underwent EBUS under general anesthesia was performed. Airways were managed with i-gel O2 by anesthesiologists unfamiliar with it. Data collected included patient characteristics, i-gel O2 positioning, mechanical ventilation, procedure, and complications occurring during and after the EBUS. RESULTS: The i-gel airway was successfully positioned during the first attempt in 34/39 cases (87.2%). No failed positioning was recorded. The EBUS scope easily passed through the i-gel in all patients and in 14 (35.6%) cases it was also inserted through the esophagus allowing the examination or fine needle aspiration of paraesophageal lymph nodes. In one case, during the EBUS procedure, the i-gel was dislocated but easily put in place again. During EBUS, air leakages were significant in 2 cases (5.1%) and minimal in 14 cases (35.9%). A brief self-solved laryngospasm and a bronchospasm during bronchoscopy were recorded. After recovery, no patients had dysphagia; mild odynophagia and pharyngodinia were referred by 2 (5.1%) and 12 (30.1%) patients, respectively. CONCLUSIONS: The i-gel O2 airway is easy to position and manage even for anesthesiologists unfamiliar with it. This supraglottic airway device is suitable for a complete endosonographic evaluation of the mediastinum.

Preventive Anti-inflammatory Diet to Reduce Gastrointestinal Inflammation in Familial Adenomatous Polyposis Patients: A Prospective Pilot Study.

Familial adenomatous polyposis (FAP) is an autosomal-dominant hereditary condition associated with germline mutations in the adenomatous polyposis coli gene. Patient management involves prophylactic surgery and intensive life-long endoscopic surveillance. Diet is a major concern for patients with FAP, who are generally free of symptoms before surgery but tend to have issues related to bowel function postoperatively. We hypothesized that a low-inflammatory diet based on the principles and recipes of the Mediterranean diet would reduce markers of local and systemic inflammation. Twenty-eight patients with FAP over 18 years of age who underwent rectum-sparing prophylactic colectomy and were included in our surveillance program participated in a pilot dietary intervention study. Blood and stool samples at baseline (T0), at the end of the dietary intervention (T1, three months), and at the end of the study (T2, six months after T0) were collected. Gastrointestinal inflammation markers including fecal calprotectin, cyclooxygenase-2, and 15-hydroxyprostaglandin dehydrogenase were evaluated. Serum calprotectin, insulin, insulin-like growth factor-1, C-reactive protein, and glycated hemoglobin were also assessed. Significant changes in serum calprotectin, insulin, and insulin-like growth factor-1 levels occurred over time. Borderline significant changes were observed in the neutrophil-lymphocyte ratio. These changes were noticeable immediately at the end of the 3-month active dietary intervention (T1). A significant increase in 15-hydroxyprostaglandin dehydrogenase expression in the normal crypts of matched samples was also observed between T0 and T2. This pilot study supports the hypothesis that a low-inflammatory diet can modulate gastrointestinal markers of inflammation in individuals with FAP. PREVENTION RELEVANCE: Cancer is known to be related to inflammatory conditions. This study suggests that anti-inflammatory dietary intervention may potentially prevent adenomas and cancer in FAP patients by reducing systemic and tissue inflammatory indices.

Risk factors for post-ERCP pancreatitis in high- and low-volume centers and among expert and non-expert operators: a prospective multicenter study.

OBJECTIVES: Prospective studies have identified a number of patient- and procedure-related independent risk factors for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, with different conclusions, so various questions are still open. The endoscopist's expertise, case volume, and case mix can all significantly influence the outcome of ERCP procedures, but have been investigated little to date. METHODS: We identified patient- and procedure-related risk factors for post-ERCP pancreatitis and the impact of the endoscopist's experience and the center's case volume, using univariate and multivariate analysis, in a multicenter, prospective study involving low- and high-volume centers, over a 6-month period. RESULTS: A total of 3,635 ERCP procedures were included; 2,838 (78%) ERCPs were performed in the 11 high-volume centers (median 257 each) and 797 in the 10 low-volume centers (median 45 each). Overall, 3,331 ERCPs were carried out by expert operators and 304 by less-skilled operators. There were significantly more grade 3 difficulty procedures in high-volume centers than in low-volume ones (P<0.0001). Post-ERCP pancreatitis occurred in 137 patients (3.8%); the rates did not differ between high- and low-volume centers (3.9% vs. 3.1%) and expert and non-expert operators (3.8% vs. 5.5%). However, in high-volume centers, there were 25% more patients with patient- and procedure-related risk factors, and the pancreatitis rate was one-third higher among non-expert operators. Univariate analysis found a significant association with pancreatitis for history of acute pancreatitis, either non-ERCP- or ERCP-related and recurrent, young age, absence of bile duct stones, and biliary pain among patient-related risk factors, and >10 attempts to cannulate the Vater's papilla, pancreatic duct cannulation, contrast injection of the pancreatic ductal system, pre-cut technique, and pancreatic sphincterotomy, among procedure-related risk factors. Multivariate analysis also showed that a history of post-ERCP pancreatitis, biliary pain, >10 attempts to cannulate the Vater's papilla, main pancreatic duct cannulation, and pre-cut technique were significantly associated with the complication. CONCLUSIONS: A history of pancreatitis among patient-related factors, and multiple attempts at cannulation among procedure-related factors, were associated with the highest rates of post-ERCP pancreatitis. Pre-cut sphincterotomy, although identified as another significant risk factor, appeared safer when done early (fewer than 10 attempts at cannulating), compared with repeated multiple cannulation. The risk of post-ERCP pancreatitis was not associated with the case volume of either the single endoscopist or the center; however, high-volume centers treated a larger proportion of patients at high risk of pancreatitis and did a significantly greater number of difficult procedures.

Bulb biopsies for the diagnosis of celiac disease in pediatric patients.

BACKGROUND: Celiac disease (CD) is a gluten-dependent enteropathy. The current standard for diagnosing CD involves obtaining 4 biopsy samples from the descending duodenum. It has been suggested that duodenal bulb biopsies may also be useful. OBJECTIVE: To assess the utility of bulbar biopsies for the diagnosis of CD in pediatric patients. DESIGN: Prospective study. SETTING: Single center. PATIENTS: Forty-seven consecutively enrolled pediatric patients with celiac serologies and a clinical suspicion of CD. INTERVENTIONS: All patients underwent EGD, and 4 biopsy samples were obtained from the duodenal bulb and 4 from the descending duodenum of each child. MAIN OUTCOME MEASUREMENTS: The pathologist blindly reported the Marsh histological grade for the diagnosis of CD of the bulb and descending duodenum. RESULTS: The diagnosis of CD was histologically confirmed in 89.4% (42/47) of the cases of biopsy samples obtained from the descending duodenum and in all 47 obtained from the bulb. In 35 patients (74.5%), histology was the same in the bulb and duodenum; in 11 (23.4%) cases, the grade of atrophy was higher in the bulb than in the descending duodenum, and 5 (10.6%) had bulb histology positive for CD but negative duodenal findings. One child (2.1%) had a higher histological grade in the duodenum than in the bulb. The diagnostic gain with bulbar biopsies was 10.6%. LIMITATIONS: Small sample and absence of a comparison group (asymptomatic children with normal CD antibodies). CONCLUSIONS: We suggest examining 4 biopsy samples from the duodenal bulb and 4 from the descending duodenum to improve diagnostic accuracy of CD.

Sentinel node mapping during laparoscopic distal gastrectomy for gastric cancer: technical notes.

BACKGROUND: With increasing experience, sentinel node navigation has been applied even to gastric cancer. Sentinel lymph nodes are identified by injecting lymphatic tracer dye and radioisotope-labeled particles around a gastric tumor into the submucosa endoscopically. The aim of this video was to demonstrate the feasibility of laparoscopic sentinel node navigation (SLN) in gastric cancer. METHODS: A 71-year-old man with a diagnosis of gastric cancer was admitted to the authors' department. The preoperative workup demonstrated a uT1 node-negative gastric cancer. The patient was scheduled for laparoscopic distal gastrectomy with SLN. The day before surgery, the patient was submitted to endoscopy. During the procedure, the radiotracer (technetium-99) was injected at four points around the tumor. The operation was performed with the patient in the Lloyd-Davies position using four trocars. After opening of the gastrocolonic ligament, the patient underwent an intraoperative endoscopy, and blue dye (patent blue) was injected at four points around the tumor. The lymphatic basin was identified with the probe and the blue dye. The sentinel node then was identified. No pickup technique was used. A standard laparoscopic gastrectomy with intracorporeal anastomosis was concluded successfully. Through a supraumbilical incision, the specimen was extracted. The sentinel node was dissected at the bench table after the operation. RESULTS: The pathologic report demonstrated a gastric carcinoma, namely, pT1, pN1 (Sentinel node (Sn), 1/36), G3 gastric cancer. Only the sentinel node was positive, containing a micrometastasis. The patient's postoperative course was uneventful. CONCLUSIONS: Sentinel node navigation with a double tracer during laparoscopic gastrectomy for cancer is feasible. Nevertheless, it is mandatory to standardize the method of SLN identification to increase the diagnosis of lymph node metastases.

Effect of transoral incisionless fundoplication on symptoms, PPI use, and ph-impedance refluxes of GERD patients.

BACKGROUND: Three previous studies from the same institution have reported that transoral incisionless fundoplication (TIF) with the EsophyX device is effective for creating a continent gastroesophageal valve and for good functional results as measured only by pH-metry in patients with gastroesophageal reflux disease (GERD). The objective of the present study was to evaluate the effect of TIF on symptoms, use of proton pump inhibitors (PPI), esophageal motility, and pH-impedance in patients with symptomatic GERD. METHODS: Twenty consecutive patients were enrolled to complete the GERD-HRQL and GERD-QUAL questionnaires while on and off PPI. They were also examined by upper gastrointestinal (GI) endoscopy to determine Hill grade and Jobe length of the gastroesophageal valve, and to check for hiatal hernia and esophagitis, esophageal manometry, and pH-impedance before and 6 months after TIF. RESULTS: Six months after TIF, the GERD-HRLQ and GERD-QUAL scores off-PPI therapy and the number of total and acid pH-impedance refluxes were significantly reduced (p < 0.05). The PPI had been completely stopped in 55% of the patient and was reduced in 22% of the patients. CONCLUSIONS: At 6-month follow-up, TIF performed using the EsophyX device reduces symptoms and pH-impedance refluxes, allowing interruption or reduction of PPI use in 78% of patients with GERD.

Reorganization of the endoscopic activity of Cancer Institutes during phase II of the Covid-19 emergency.

After the lockdown during the emergency phase of the Covid-19 pandemic, we have to deal with phase 2, a period of uncertain duration, with a controlled and progressive return to normalization, in which we need to reconcile our work and our movements with the presence of the virus on our territory. Digestive endoscopic activity is a high-risk transmission procedure for Covid-19. The measures put in place to protect healthcare personnel and patients are stressful and "time-consuming" and lead to a reduction in the number of endoscopic procedures that can be performed. In this scenario, the Oncological Institutes are forced to make a rigorous selection of patients to undergo endoscopic examinations and treatments, according to lists of exceptional priorities, in order to guarantee cancer patients and subjects at high risk of developing digestive tumors, a preferential diagnostic and therapeutic process, protected from contagion risks. For this purpose, cuts and postponing times of endoscopic performances are here proposed, which go beyond the guidelines of scientific societies and have little evidences in the literature. These changes should be applied limited to this exceptional period and in proportion to the capacity of each operating unit in order to meet the demands of the patients.