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.

Repeated endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions after previous nondiagnostic or inconclusive sampling.

OBJECTIVES: Repeated endoscopic ultrasound (EUS)-guided tissue acquisition represents the standard practice for solid pancreatic lesions after previous nondiagnostic or inconclusive results. Since data are lacking, we aimed to evaluate the diagnostic performance of repeated EUS fine-needle biopsy (rEUS-FNB) in this setting. The primary outcome was diagnostic accuracy; sample adequacy, sensitivity, specificity, and safety were secondary outcomes. METHODS: Consecutive patients undergoing rEUS-FNB for solid pancreatic lesions at 23 Italian centers from 2019 to 2021 were retrieved. Pathology on the surgical specimen, malignant histology together with ≥6-month follow-up, and benign pathology together with ≥12-month follow-up were adopted as gold standards. RESULTS: Among 462 patients, 56.5% were male, with a median age of 68 (59-75) years, malignancy prevalence 77.0%. Tumor size was 26 (20-35) mm. Second-generation FNB needles were used in 89.6% cases. Diagnostic accuracy, sensitivity, and specificity of rEUS-FNB were 89.2%, 91.4%, and 81.7%, respectively (19 false-negative and 12 false-positive results). On multivariate analysis, rEUS-FNB performed at high-volume centers (odds ratio [OR] 2.12; 95% confidence interval [CI] 1.10-3.17; P = 0.03) and tumor size (OR 1.03; 95% CI 1.00-1.06; P = 0.05) were independently related to diagnostic accuracy. Sample adequacy was 94.2%. Use of second-generation FNB needles (OR 5.42; 95% CI 2.30-12.77; P < 0.001) and tumor size >23 mm (OR 3.04; 95% CI 1.31-7.06; P = 0.009) were independently related to sample adequacy. CONCLUSION: Repeated EUS-FNB allowed optimal diagnostic performance after nondiagnostic or inconclusive results. Patients' referral to high-volume centers improved diagnostic accuracy. The use of second-generation FNB needles significantly improved sample adequacy over standard EUS-FNB needles.

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.).

Efficacy of a new nutraceutical formulation: L-tryptophan, probiotics, charcoal, chamomile, mint, and licorice (COLONIR®) in the improvement of gastrointestinal symptoms in subjects with irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders. IBS is characterized by recurrent chronic abdominal pain and altered bowel habits in the absence of organic damage. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS presentation make treatment difficult. Treatment of IBS focuses on relieving symptoms as mild signs and symptoms can often be controlled by managing stress and by making changes in diet and lifestyle. The use of nutraceutical compounds has been advocated as a possible alternative treatment in patients with IBS. COLONIR® (Omega Pharma Srl, Milan, Italy) may be an alternative or adjuvant treatment in patients with gastrointestinal symptoms. This study aimed to evaluate the effect of this new nutraceutical formulation in inducing symptoms remission and improve gastrointestinal habits. METHODS: An initial cohort of 1004 consecutive patients referred to 25 different Units of Internal Medicine a/o Gastroenterology in Italy to perform colonoscopy for intestinal symptoms was asked to participate. Patients were treated for 2 months with two doses of nutraceuticals/day during meals namely COLONIR®. Patients were assessed at baseline and after 2 months to evaluate the frequency and severity of gastrointestinal symptoms in the past seven days with a questionnaire based on ROMA IV criteria. RESULTS: After 2 months, 899 patients completed the follow-up. COLONIR® achieved a statistically significant reduction of severity of symptoms in the study population without any documented side effects. CONCLUSIONS: These promising results, here reported, need to be confirmed, valuating the efficacy of COLONIR® in relieving gastrointestinal symptoms in IBS patients in further studies.

Outcomes of Double Balloon-Enteroscopy in Elderly vs. Adult Patients: A Retrospective 16-Year Single-Centre Study.

Background and Aim: Double-balloon enteroscopy (DBE) is a well-established procedure for direct visualisation of the entire small bowel mucosa, and, in contrast with other imaging techniques, allows to perform biopsies and therapeutic interventions. The aim of this study was to evaluate the indications, diagnostic yield, therapeutic yield, and complications of DBE in a cohort of consecutive patients according to patients' age. Methods: We conducted a retrospective study of consecutive patients who underwent DBE in our endoscopy unit between January 2006 and December 2021. Results: A total of 387 consecutive patients who underwent 460 DBE procedures were included. Mean age of the patients was 63 years. The overall diagnostic yield was 67.6%; vascular lesions were the predominant endoscopic findings (31.5%), followed by polyps or neoplastic masses (17.6%). Older patients (≥65 years) showed statistically higher rates of clinically relevant findings than adult patients (18-65 years) (p = 0.001). Crohn's disease and polyps or neoplastic masses were more frequent in the younger group (p = 0.009 and p = 0.066, respectively), while vascular lesions and non-specific inflammation were the most common findings in the older group (p < 0.001 and p < 0.001, respectively). The therapeutic intervention rate was 31.7%. Rates of endoscopic treatment were significantly higher in the older group (p < 0.001). Total complications occurred in five procedures (1.1%). Conclusion: In clinical practice, DBE is an efficient diagnostic and therapeutic tool with a high safety profile, particularly in the elderly population.

Long-term efficacy of vacuum-assisted therapy (Endo-SPONGE®) in large anastomotic leakages following anterior rectal resection.

BACKGROUND: The aim of our study was to test the long-term efficacy of Endo-SPONGE® therapy in a group of patients treated in our center with vacuum-assisted therapy because of anastomotic leakages after colorectal surgery. METHODS: Eleven patients [male: 6; mean age: 71 (range: 44-82) years] who had anastomotic leakage treated with Endo-SPONGE® placement were included in the study. Patient records were examined retrospectively. All patients with documented anastomotic leakage on abdominal computed tomography following an anterior resection of the rectum for rectal cancer underwent sigmoidoscopy to determine the extent of the anastomotic defect and the size of the presacral abscess. RESULTS: Ten of the 11 patients (90.9%) showed closure of the anastomotic leakage after a mean of 16 sponge changes. During follow up [mean: 29 (range: 6-64) months], we observed two cases of anastomotic stricture. Treatment failure was observed in one patient who presented an increased size of dehiscence after 23 sessions of endoscopic treatment, despite an initial good response. CONCLUSIONS: Our study substantially confirms previous conclusions and reaffirms that Endo-SPONGE® treatment for colorectal anastomotic leakages, performed in suitable patients, represents a successful and safe approach. The reduction in wound closure time, mild-to-moderate discomfort and possibly shorter hospitalization suggest that Endo-SPONGE® treatment can be a prominent therapeutic regimen with adequate patient acceptance.

MiroCam capsule for obscure gastrointestinal bleeding: a prospective, single centre experience.

BACKGROUND: Capsule endoscopy is an established tool for the evaluation of obscure gastrointestinal bleeding but published literature is mostly limited to PillCam SB (Given Imaging, Israel). AIMS: The aims of this study were to determine the findings, the diagnostic yield and the rebleeding rate in a series of patients with overt or occult obscure gastrointestinal bleeding studied with MiroCam(Intromedic, Seoul, Korea) capsule endoscopy. METHODS: Data of 118 patients who underwent capsule endoscopy for overt or occult obscure gastrointestinal bleeding were prospectively collected between March 2009 and March 2011. RESULTS: Evaluation of the entire small bowel (completion rate) was achieved in 96% of cases. Relevant lesions occurred in 58% of patients. Angiodysplasias was the most common finding. Six patients (9% of the positive findings) had a non-small-bowel lesion detected by capsule. The yield of capsule endoscopy in the overt group was greater than in the occult group but without achieving a significant difference (61% vs. 54%, p>0.05). Rebleeding rate was lower in patients with a negative examination (6%) than in patients with a positive one (17%) (p=0.03). Capsule retention was registered in 3 of 118 patients (2.5%). CONCLUSIONS: MiroCam capsule endoscopy is a safe and effective tool for exploring small bowel with a high completion rate.