COVID-19 Digestive System Involvement and Clinical Outcomes in a Large Academic Hospital in Milan, Italy.

Since February 2020, the COVID-19 pandemic has spread to Italy affecting more than 100,000 people. Several studies have reported a high prevalence of gastrointestinal (GI) symptoms, and investigated their potential association with clinical outcomes.1 The timing, clinical significance, and possible impact on viral spread of GI symptoms presentation have not been fully elucidated. Elevation of liver function tests and other laboratory values has also been reported; however, their prognostic significance has not been clearly established.2.

New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video).

BACKGROUND AND AIMS: In recent years, the feasibility and safety of endoscopic placement of different biodegradable biliary stents have been investigated. New, helicoidally shaped, biliary and pancreatic biodegradable stents have been developed for endoscopic use. Stents are provided in different sizes and with 3 expected speeds of degradation: slow (11 weeks), medium (20 days), and fast (12 days). The aim of this study was to evaluate degradation time, technical outcomes, and safety of these stents. METHODS: This was a single-center, prospective, pilot study (August 2018 to January 2019) of consecutive patients with indication for biliary or pancreatic plastic stent positioning during ERCP. The primary outcome was the evaluation of degradation time of the stents, which was controlled by abdominal radiograph. Secondary outcomes were the evaluation of specific stent-related technical features (loadability, pushability, and fluoroscopic visibility) as compared with commonly used plastic stents and adverse events (AEs). RESULTS: Thirty-eight patients (11 women [28.9%]; median age, 68.05 ± 10.74 years) who received 53 biodegradable stents (34 [64.2%] biliary and 19 [35.8%] pancreatic stents) were enrolled in the study. Thirty-five (66%) slow-degrading stents, 6 (11.3%) medium-degrading stents, and 12 (22.6%) fast-degrading stents were used. At time 1, partial degradation of the stents was present in 48 cases (90.6%). Five stents (9.4%) prematurely migrated. At the subsequent time 2 evaluation, complete degradation occurred in 100% of cases. Stent loadability was defined as excellent in all cases. Pushability of the stent was scored as excellent in 48 cases (90.5%), good in 4 cases (7.5%), and fair in 1 case (1.9%). Fluoroscopic visualization was excellent in 11 cases (20.8%), good in 39 cases (73.6%), and fair in 3 (5.6%). Only 1 AE of mild post-ERCP pancreatitis occurred. CONCLUSIONS: The results of our study suggest that the biodegradation of the new biliary and pancreatic stents is reliable and in line with expected times and technically successful in a variety of indications. Further randomized multicenter studies are required to validate our preliminary findings. (Clinical trial registration number: NCT03767166.).

Pancreatic Neuroendocrine Tumours: The Role of Endoscopic Ultrasound Biopsy in Diagnosis and Grading Based on the WHO 2017 Classification.

BACKGROUND: One of the controversial issues in the diagnosis of pancreatic neuroendocrine tumours (pNETs) is the accurate prediction of their clinical behaviour. OBJECTIVES: The aim of the study was to evaluate the role of endoscopic ultrasound (EUS) biopsy in the diagnosis and grading of pNETs in a certified ENETS Center. METHODS: A prospectively maintained database of EUS biopsy procedures was retrospectively reviewed to identify all consecutive patients referred to a certified ENETS Center with a suspicion of pNET between June 2014 and April 2017. The cytological and/or histological specimens were stained and the Ki-67 labeling index was evaluated. In patients undergoing surgery, the grade obtained with EUS-guided biopsy was compared with the final histological grade. The grade was evaluated according to the 2017 WHO classifications and grading. RESULTS: The study population included 59 patients. EUS biopsy material reached an adequacy of 98.3% and was adequate for Ki-67 evaluation in 84.7% of cases. Twenty-nine patients (49.2%) underwent surgery. Of these, 25 patients had Ki-67 evaluated on EUS biopsy: the agreement between EUS biopsy grading and surgical specimen grading was 84%. CONCLUSION: EUS biopsy is an accurate method for the diagnosis and grading of pNETs based on the WHO 2017 Ki-67 labelling scheme.

EUS elastography (strain ratio) and fractal-based quantitative analysis for the diagnosis of solid pancreatic lesions.

BACKGROUND AND AIMS: EUS elastography is useful in characterizing solid pancreatic lesions (SPLs), and fractal analysis-based technology has been used to evaluate geometric complexity in oncology. The aim of this study was to evaluate EUS elastography (strain ratio) and fractal analysis for the characterization of SPLs. METHODS: Consecutive patients with SPLs were prospectively enrolled between December 2015 and February 2017. Elastographic evaluation included parenchymal strain ratio (pSR) and wall strain ratio (wSR) and was performed with a new compact US processor. Elastographic images were analyzed using a computer program to determine the 3-dimensional histogram fractal dimension. A composite cytology/histology/clinical reference standard was used to assess sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating curve. RESULTS: Overall, 102 SPLs from 100 patients were studied. At final diagnosis, 69 (68%) were malignant and 33 benign. At elastography, both pSR and wSR appeared to be significantly higher in malignant as compared with benign SPLs (pSR, 24.5 vs 6.4 [P < .001]; wSR, 56.6 vs 15.3 [P < .001]). When the best cut-off levels of pSR and wSR at 9.10 and 16.2, respectively, were used, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating curve were 88.4%, 78.8%, 89.7%, 76.9%, and 86.7% and 91.3%, 69.7%, 86.5%, 80%, and 85.7%, respectively. Fractal analysis showed a significant statistical difference (P = .0087) between the mean surface fractal dimension of malignant lesions (D = 2.66 ± .01) versus neuroendocrine tumor (D = 2.73 ± .03) and a statistical difference for all 3 channels red, green, and blue (P < .0001). CONCLUSIONS: EUS elastography with pSR and fractal-based analysis are useful in characterizing SPLs. (Clinical trial registration number: NCT02855151.).

Multicentric Italian survey on daily practice for autoimmune pancreatitis: Clinical data, diagnosis, treatment, and evolution toward pancreatic insufficiency.

BACKGROUND: Autoimmune pancreatitis (AIP) is a rare, and relatively new, form of chronic pancreatitis. The management of AIP can vary considerably among different centres in daily clinical practice. OBJECTIVES: The aim of this study is to present a picture of epidemiological, clinical characteristics, outcomes, and the real-life practice in terms of management in several academic and non-academic centres in Italy. METHODS: Data on the clinical presentation, diagnostic work-up, treatments, frequency of relapses, and long-term outcomes were retrospectively collected in a cohort of AIP patients diagnosed at 14 centres in Italy. RESULTS: One hundred and six patients were classified as type 1 AIP, 48 as type 2 AIP, and 19 as not otherwise specified. Epidemiological, clinical, radiological, and serological characteristics, and relapses were similar to those previously reported for different types of AIP. Endoscopic cytohistology was available in 46.2% of cases, and diagnostic for AIP in only 35.2%. Steroid trial to aid diagnosis was administered in 43.3% cases, and effective in 93.3%. Steroid therapy was used in 70.5% of cases, and effective in 92.6% of patients. Maintenance therapy with low dose of steroid (MST) was prescribed in 25.4% of cases at a mean dose of 5 (±1.4) mg/die, and median time of MST was 60 days. Immunosuppressive drugs were rarely used (10.9%), and rituximab in 1.7%. Faecal elastase-1 was evaluated in only 31.2% of patients, and was pathological in 59.2%. CONCLUSIONS: In this cohort of AIP patients, diagnosis and classification for subtype was frequently possible, confirming the different characteristics of AIP1 and AIP2 previously reported. Nevertheless, we observed a low use of histology and steroid trial for a diagnosis of AIP. Steroid treatment was the most used therapy in our cohort. Immunosuppressants and rituximab were rarely used. The evaluation of exocrine pancreatic insufficiency is underemployed considering its high prevalence.

Biologic Therapies in Ulcerative Colitis: Primi Inter Pares?

BACKGROUND: In the last decade, the introduction of the first anti-tumor necrosis factor (TNF)-α agent infliximab has revolutionized the treatment of ulcerative colitis (UC). However, this drug is not a magic bullet since up to 50% of UC patients do not respond (primary failure) or lose response to infliximab (secondary failure). Hence the demand for novel drugs to fill the unmet medical need. OBJECTIVE: The aim of this review is to discuss the data from randomized controlled trials (RCTs) of available biological agents for the treatment of moderate-to-severe UC in adults, in order to support clinical decision making. RESULTS AND CONCLUSION: New biological agents are now available for the treatment of moderate-tosevere UC. Adalimumab and golimumab are anti-TNF-α monoclonal antibodies, as is infliximab, whereas vedolizumab blocks the integrin α4ß7/mucosal addressin cell adhesion molucule-1 (MAd- CAM). Additions to the therapeutic arsenal boost the chances of successful treatment of UC, but lead to difficulty choosing the most appropriate biological drug: which biologic to use first and when and how to switch. In the absence of head-to-head trials to answer these questions, a network metaanalysis of the available RCTs can provide estimates of relative efficacy between interventions. Other factors, including convenience and satisfaction for the patient, route of administration, the cost of treatment, and the safety and efficacy profile, should all be considered.

WallFlex colonic stent placement for management of malignant colonic obstruction: a prospective study at two centers.

BACKGROUND: Self-expanding metal stents (SEMSs) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. The use of colonic larger-diameter SEMSs may improve bowel function and reduce migration risk. OBJECTIVE: To evaluate the effectiveness and safety of a novel large-diameter SEMS (WallFlex) designed for delivery through the endoscope in treating malignant colonic obstruction. DESIGN: Prospective clinical cohort study. SETTING: Two Italian study centers. PATIENTS: Forty-two consecutive patients with malignant colonic obstruction: 23 requiring palliation and 19 bridging to surgery. INTERVENTIONS: Colorectal SEMS placement. MAIN OUTCOME MEASUREMENTS: Technical success, defined as accurate SEMS deployment across the stricture on the first attempt; clinical success, ie, complete relief of bowel obstruction without complications; and bridging to surgery, denoting the performance of elective one-stage surgery. RESULTS: The rate of technical success was 93% (95% CI, 81%-99%) and of initial clinical success was 95% (95% CI, 84%-99%). In 58% (95% CI, 40%-84%) of the palliation group, clinical success was maintained after 6 months. All 19 patients with operable tumors were successfully bridged to one-stage elective surgery within a median of 5 days. One perforation and one stent migration occurred. All complications could be resolved nonsurgically. LIMITATIONS: No control group was included. CONCLUSIONS: In a prospective study of through-the-scope WallFlex stent placement for malignant colonic obstruction, high rates of technical and initial clinical success, and bridging to surgery were achieved. Complications could be readily managed.

Stenting of the proximal colon in patients with malignant large bowel obstruction: techniques and outcomes.

BACKGROUND: Self-expandable metal stents are used throughout the GI tract to relieve malignant obstructions. OBJECTIVE: Our purpose was to determine the outcome after colonic stent placement into the proximal colon. DESIGN: Medical records of patients from 3 institutions who underwent attempts at placement of self-expandable metal stents for malignant obstructions of the proximal colon were retrospectively reviewed. Extracted data included patient characteristics, obstruction location, and goal of procedure (palliation vs bridge to surgery). SETTING: Academic medial centers. PATIENTS: Those with right-sided malignant colonic obstruction. INTERVENTIONS: Placement of colonic stent. MAIN OUTCOME MEASUREMENTS: Initial technical success, relief of obstruction, and early and long-term complications. RESULTS: Twenty-one patients (15 men, 6 women; mean age 67 years) were included. Tumor type was colonic adenocarcinoma in 19 patients. Obstruction was complete in 8 patients and subtotal in 13 patients. Stenting was attempted as a bridge to surgery in 8 patients and as palliation in 13 patients. Initial technical success was achieved in 20 of 21 patients (95%). Complete relief of obstruction was achieved in 17 of 20 patients who had technical success (85%), unachieved in 2 patients (No. 14 and 17), and unknown in 1 patient (No. 6). There were no procedure-related complications (bleeding, perforation, etc). The only long-term complication was stent reocclusion from tumor ingrowth. LIMITATIONS: Retrospective, single-arm analysis. CONCLUSIONS: Self-expandable metal stents appear to be safe and effective in the treatment of malignant obstruction of the proximal colon. Technical and clinical success rates are comparable to those seen with distal colonic stenting.

Metal stents for malignant colorectal obstruction.

Malignant obstruction of the colon occurs in 7-25% of patients with colorectal cancer. As emergency laparotomy is reported to have relatively high morbidity and mortality rate, there is a need for alternative procedures with reduced complication rates. Over the last decade colorectal stenting has been reported as an alternative endoscopic method to relieve acute colonic obstruction. With the availability of more sophisticated stents and stent delivery systems, this approach has been used as a palliative method and as a pre-operative bridge to facilitate one-stage surgical resection of primary colonic tumors. Technical and clinical successes have been reported in 80-100% of treated patients. Distal lesions are more common and theoretically easier to stent although lesions within the ascending colon have been successfully managed. Minor complications include transient anorectal pain, tenesmus and rectal bleeding. However, stent migration and colonic perforation are also well recognized. Despite the fact that no randomized controlled studies have yet been performed, literature data show that colonic stenting is a safe and effective procedure and can reduce costs, avoiding the need for colostomy and improving the quality of life of patients with advanced disease.