Endoscopic ultrasound-guided gallbladder drainage as a first approach for jaundice palliation in unresectable malignant distal biliary obstruction: Prospective study.

OBJECTIVES: Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in patients with distal malignant biliary obstruction (DMBO). Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. In a palliative setting the endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) could represent an easy and valid option. We performed a prospective study with a new EC-LAMS with the primary aim to assess the clinical success rate of EUS-GBD as a first-line approach to the palliation of DMBO. METHODS: In all, 37 consecutive patients undergoing EUS-GBD with a new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease >15% within 24 h and >50% within 14 days after EC-LAMS placement. RESULTS: The mean age was 73.5 ± 10.8 years; there were 17 male patients (45.9%). EC-LAMS placement was technically feasible in all patients (100%) and the clinical success rate was 100%. Four patients (10.8%) experienced adverse events, one bleeding, one food impaction, and two cystic duct obstructions because of disease progression. No stent-related deaths were observed. The mean hospitalization was 7.7 ± 3.4 days. Median overall survival was 4 months (95% confidence interval 1-8). CONCLUSION: Endoscopic ultrasound-guided gallbladder drainage with the new EC-LAMS is a valid option in palliative endoscopic biliary drainage as a first-step approach in low survival patients with malignant jaundice unfit for surgery. A smaller diameter EC-LAMS should be preferred, particularly if the drainage is performed through the stomach, to avoid potential food impaction, which could result in stent dysfunction.

The Use of a New Dedicated Electrocautery Lumen-Apposing Metal Stent for Gallbladder Drainage in Patients with Acute Cholecystitis.

Aims: Lumen-apposing metal stents (LAMSs) in ultrasonography-guided gallbladder drainage (EUS-GBD) have become increasingly important for high-risk surgical patients. Our study aims to evaluate the technical and clinical success, safety, and feasibility of endoscopic ultrasonography-guided gallbladder drainage using a new dedicated LAMS. Methods: This is a retrospective multicenter study that included all consecutive patients not suitable for surgery who were referred to a tertiary center for EUS-GBD using a new dedicated electrocautery LAMS for acute cholecystitis at eight different centers. Results: Our study included 54 patients with a mean age of 76.48 years (standard deviation: 12.6 years). Out of the 54 endoscopic gallbladder drainages performed, 24 (44.4%) were cholecysto-gastrostomy, and 30 (55.4%) were cholecysto-duodenostomy. The technical success of LAMS placement was 100%, and clinical success was achieved in 23 out of 30 patients (76.67%). Adverse events were observed in two patients (5.6%). Patients were discharged after a median of 5 days post-stenting. Conclusions: EUS-GBD represents a valuable option for high-surgical-risk patients with acute cholecystitis. This new dedicated LAMS has demonstrated a high rate of technical and clinical success, along with a high level of safety.

EUS-guided biliary drainage with a novel electrocautery-enhanced lumen apposing metal stent as first approach for distal malignant biliary obstruction: a prospective study.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in malignant biliary obstruction (MBO) patients. Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. We aimed to assess the technical and clinical success of a new EC-LAMS as the first approach to the palliation of malignant jaundice due to MBO in patients unfit for surgery. Patients and methods Twenty-five consecutive patients undergoing endoscopic-guided biliary drainage with the new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease > 15 % 24 hours after EC-LAMS placement. Results Mean age was 76.6 ±â€Š11.56 years, and male patients were 10 (40 %). EC-LAMS placement was technically feasible in 24 patients (96 %) and clinical success rate was 100 %. Only one patient (4 %) experienced a misplacement rescued by an immediate second EC-LAMS placement. The mean duration of hospital stay was 4.66 ±â€Š4.22 days. The median overall survival was 7 months (95 % CI 1-7). Conclusions In this preliminary study, the new EC-LAMS seems to allow a single-step palliative endoscopic therapy in patients affected by jaundice due to MBO, with high technical and clinical success and low adverse events. Further large prospective studies are warranted to validate these results.

Gastric duplication cyst: a challenging EUS differential diagnosis between subepithelial gastric lesion and exophytic pancreatic cystic neoplasm-a case report and a literature review.

Gastric duplication cysts are rare congenital malformation with a potential neoplastic progression and they may represent a challenge in differential diagnosis with exophytic pancreatic cyst neoplasm. We describe a case of a 38-year old man, complaining of recurrent epigastric pain due to a large abdominal mass, referred to our Hospital for EUS evaluation. Differential diagnosis was between gastric duplication cyst and exophytic pancreatic cyst because of FNA pointed out amylase 1280 UI/L and CEA 593.33 ng/mL. Despite antibiotic prophylaxis, an overinfection of the lesion occurred after the FNA, likely due to the technical failure to drain the cyst completely. Afterwards, the patient was referred to surgery and the pathologist confirmed the diagnosis of gastric duplication cyst. In this setting, EUS procedure has gained a leading play, complementary to traditional imaging tests, although its role has been not yet standardized in the reported literature. Here, we describe and discuss our demanding case, and we propose an algorithm to simplify and standardize the diagnostic workup.

Is Ustekinumab Effective in Refractory Crohn's Disease of the Pouch and Chronic Pouchitis? A Systematic Review.

Crohn's disease (CD) of the pouch and chronic pouchitis represent the most common long-term complications of total proctocolectomy and ileal pouch anal anastomosis (IPAA) for refractory ulcerative colitis (UC). These conditions are treated with multiple agents, including antibiotics, immunomodulators, and biologics. Among the latter, ustekinumab is approved for both CD and UC. We performed a systematic review to evaluate the efficacy of this anti-IL12/23 in CD of the pouch and chronic refractory pouchitis. Pubmed, Embase, Ovid, and the Cochrane Controlled Trials Register were searched to identify studies published until August 2020 investigating the use of ustekinumab for these conditions. Eighty-six eligible patients with IPAA-51 with CD of the pouch, 35 with chronic pouchitis-were identified from 2 retrospective studies and 5 case reports. Reported clinical response to ustekinumab was 63 and 85% in chronic pouchitis and CD of the pouch after 4-12 and 4-16 weeks, respectively. Clinical remission was reported in 10% of patients with chronic pouchitis and 27% of patients with CD of the pouch after 8-52 and 4-52 weeks of treatment, respectively. Endoscopic response was reported in 60% and 67% of patients with chronic pouchitis and CD of the pouch after 24-32 and 8-24 weeks of treatment respectively. Small sample sizes and large heterogeneity of therapy protocols/outcome definitions were significant studies limitations. In conclusion, there is a limited and inconclusive body of evidence suggesting that ustekinumab may be a therapeutic option for patients with chronic pouchitis and CD of the pouch refractory to other therapies.

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.

EUS-guided core biopsies of pancreatic solid masses using a new fork-tip needle: A multicenter prospective study.

BACKGROUND AND AIM: Endoscopic ultrasound-guided sampling (EUS sampling) is a safe and effective technique. The study aim was to evaluate the presence of a histological core from pancreatic lesions using a new 25G fork-tip needle. METHODS: Observational multicenter prospective and analytical study, including consecutive patients with solid pancreatic masses referred for EUS-guided sampling. At each needle pass, the endoscopist performed macroscopic on-site evaluation (MOSE). The primary outcome was the histological core procurement rates. Secondary outcomes were the evaluation of interobserver agreement between endoscopists and pathologists, adequacy of EUS samples for the diagnosis and post-procedure adverse events. RESULTS: 100 patients were enrolled in 3 centers. The mean size of the lesions was 28.5 mm (SD 11.7). Final diagnoses were adenocarcinoma (68%), neuroendocrine tumor (21%), inflammatory mass/benign lesions (8.0%), and pancreatic metastasis (3.0%). The pathologists described the presence of a core in 67 samples (67.0% of patients), with poor agreement with MOSE (kappa, 0. 12; 95% CI: 0.03-0.28). The diagnostic accuracy was 93%. We observed 6% of mild adverse events. CONCLUSION: The new 25-gauge core needle showed good overall adequacy and a good rate of histological specimens during EUS sampling of solid pancreatic masses, with a minimum number of passes and no major complications. Clinicaltrial.gov number, NCT02946840.

Self-Expanding Metal Stents for the Treatment of Post-Surgical Esophageal Leaks: A Tertiary Referral Center Experience.

BACKGROUND/AIMS: The study aimed to evaluate the effectiveness and safety of self-expanding metal stents (SEMS) in the management of post-surgical esophageal leaks. METHODS: Retrospective data of consecutive patients with a post-surgical esophageal leak treated by means of a metal stent between January 2008 and December 2014 at the Humanitas Research Hospital (Milan, Italy) were extracted from a prospectively maintained register of SEMS used for benign indications, such as post-surgical benign esophageal strictures and/or leaks. The primary outcome of the study was to assess the rate of successful leak closure and to identify the variables associated with its achievement. As a secondary outcome, we evaluated the overall safety of SEMS placement and the efficacy and safety for different types of SEMS in this specific setting of patients. Leak resolution was documented with endoscopic and/or imaging studies. In the case of leak persistence, further attempts of esophageal stenting were carried out at the discretion of both endoscopists and surgeons. RESULTS: A total of 49 patients were included in the study (men 41 of 49, 83.7%, mean age 62.4 ± 11.9). One patient was excluded from analysis, because of death 1 day after stent insertion due to worsening of pre-existing mediastinitis. A total number of 82 stents were placed (mean number of stents per patient: 1.7) in 49 patients: 35 patients (71.4%) received a partially covered SEMS (PCSEMS) as the first stent positioned, while the remaining 14 (28.6%) received a fully covered SEMS (FCSEMS); but 1 patient (2%) died following stent insertion; therefore, data regarding therapeutic success were available for 48 patients. Stents were left in place for a mean period of 21.9 ± 15.2 days. Leak closure after the first stent placement was achieved in 22 of 48 (45.8%) patients. Of the 26 patients with failure of index stent placement, 18 patients underwent further stenting attempts (69.2%), and secondary closure of leak was achieved in 7 (38.9%) of these 18 patients. Thus, the overall success rate was 60.5% (29 of 48). On the basis of stent type, the success rate was 57.1% (8 of 14) for FCSEMS and 64.7% (22 of 34) for PCSEMS. Logistic regression analysis did not find any significant association between successful leak closure and analyzed variables. Overall mortality was 13.0%. Complication rate was 38.8% (19 of 49 patients). CONCLUSION: The use of SEMS is an effective and safe option for post-surgical esophageal leaks, with no evidence of any significant influence of stent type on outcome.

Risk of Adverse Pregnancy Outcomes in Women with CKD.

CKD is increasingly prevalent in pregnancy. In the Torino-Cagliari Observational Study (TOCOS), we assessed whether the risk for adverse pregnancy outcomes is associated with CKD by comparing pregnancy outcomes of 504 pregnancies in women with CKD to outcomes of 836 low-risk pregnancies in women without CKD. The presence of hypertension, proteinuria (>1 g/d), systemic disease, and CKD stage (at referral) were assessed at baseline. The following outcomes were studied: cesarean section, preterm delivery, and early preterm delivery; small for gestational age (SGA); need for neonatal intensive care unit (NICU); new onset of hypertension; new onset/doubling of proteinuria; CKD stage shift; "general" combined outcome (preterm delivery, NICU, SGA); and "severe" combined outcome (early preterm delivery, NICU, SGA). The risk for adverse outcomes increased across stages (for stage 1 versus stages 4-5: "general" combined outcome, 34.1% versus 90.0%; "severe" combined outcome, 21.4% versus 80.0%; P<0.001). In women with stage 1 CKD, preterm delivery was associated with baseline hypertension (odds ratio [OR], 3.42; 95% confidence interval [95% CI], 1.87 to 6.21), systemic disease (OR, 3.13; 95% CI, 1.51 to 6.50), and proteinuria (OR, 3.69; 95% CI, 1.63 to 8.36). However, stage 1 CKD remained associated with adverse pregnancy outcomes (general combined outcome) in women without baseline hypertension, proteinuria, or systemic disease (OR, 1.88; 95% CI, 1.27 to 2.79). The risk of intrauterine death did not differ between patients and controls. Findings from this prospective study suggest a "baseline risk" for adverse pregnancy-related outcomes linked to CKD.

Miocamycin-containing triple therapy for H. pylori infection.

INTRODUCTION: In Northern Sardinia, one-week triple standard therapies containing a proton-pump inhibitor and two antibiotics for H. pylori infection have an average cure rate of 57% largely due to a high prevalence of antimicrobial resistance. The efficacy of miocamycin-containing treatment for 10 days was evaluated. MATERIALS AND METHODS: Patients referred to the endoscopy service for dyspeptic symptoms were enrolled. H. pylori infection was defined as a positive rapid urease test, presence of the bacteria on gastric biopsies, and a positive 13C-UBT. Treatment consisted of 10 days with omeprazole 20 mg, miocamycin water-soluble 900 mg, and tinidazole 500 mg all bid. Success was evaluated 40-50 days after the end of therapy and defined by a negative 13C-UBT. Compliance was considered good if at least 90% of the total number of the pills were taken. Fluorescent in situ hybridization (FISH) technique was applied on paraffin-embedded gastric tissue sections to test susceptibility to clarithromycin of the bacteria. RESULTS: 50 patients were enrolled (mean age; 52, 36% men). Miocamycin-containing therapy cured 86% (42/49; 95% CI = 72-94%) of infected patients by PP analysis. Susceptibility data (FISH) was available for 38 patients. Cure rates for the 28 with clarithromycin-susceptible infection was 96% vs 50% for those with resistant or mixed infection, (p = .003). Good compliance was recorded in 48 patients. None of the patients discontinued therapy. CONCLUSIONS: Miocamycin appears to be a valid alternative for clarithromycin for H. pylori eradication. Head-to-head studies will be needed to ascertain whether it is superior.