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Temozolomide (TEM) as a single agent or in combination with capecitabine (CAPTEM) is active in well-differentiated advanced neuroendocrine tumors (NETs) of gastro-entero-pancreatic and thoracic origin. The predictive role of MGMT-promoter methylation in this setting is controversial. We sought to prospectively evaluate the MGMT-promoter methylation status ability to predict outcomes to TEM-based chemotherapy in patients with NET. A single-center, prospective, observational study has been conducted at the ENETS Center-of-Excellence Outpatient Clinic of the IRCCS Policlinico Sant’Orsola-Malpighi in Bologna, Italy. Patients with advanced, gastro-entero-pancreatic or lung well-differentiated NETs candidate to TEM-based chemotherapy and with available tumor samples for MGMT-promoter methylation assessment were included. The MGMT-promoter methylation status was analyzed by using pyrosequencing. The primary endpoint was progression-free survival (PFS) by the MGMT-promoter methylation status. Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Survival outcomes were compared by restricted mean survival time (RMST) difference. Of 26 screened patients, 22 were finally enrolled in the study. The most frequent NET primary sites were the pancreas (64%) and the lung (23%). MGMT promoter was methylated in five tumors (23%). At a median follow-up time of 47.2 months (95%CI 29.3–89.7), the median PFS was 32.8 months (95%CI 17.2–NA), while the median OS was not reached. Patients in the methylated MGMT group, when compared to those in the unmethylated MGMT group, had longer PFS (median not reached [95%CI NA–NA] vs. 30.2 months [95%CI 15.2–NA], respectively; RMST p = 0.005) and OS (median not reached [95%CI NA–NA] vs. not reached [40.1–NA], respectively; RMST p = 0.019). After adjusting for confounding factors, the MGMT-promoter methylation status was independently associated to the PFS. Numerically higher ORR (60% vs. 24%; p = 0.274) and DCR (100% vs. 88%; p = 1.00) were observed in the methylated vs. unmethylated MGMT group. TEM-based chemotherapy was well-tolerated (adverse events grade ≥3 < 10%). In this prospective study, MGMT-promoter methylation predicted better outcomes to TEM-based chemotherapy in patients with NET.

Background Surgery is the first-choice treatment for malignant intestinal obstruction (MIO); however, many patients are deemed unfit for surgery. Endoscopic ultrasound-guided entero-colostomy (EUS-EC) with a lumen-apposing metal stent (LAMS) could represent a new treatment option. Methods Consecutive patients undergoing EUS-EC for MIO from November 2021 to September 2023 at four European tertiary referral centers were retrospectively enrolled. Multidisciplinary meetings determined whether patients were unsuitable for surgery or colonic stent placement, or refused surgery. The primary outcome was technical success of EUS-EC and secondary outcomes were clinical outcome, safety, and hospital stay. Results 12 patients were enrolled (median age 72.5 [range 42–85] years; 58.3% female). Colonic adenocarcinoma was the primary tumor in 75.0% of patients and 91.7% had stage IV disease. Technical success was 100%. No LAMS misdeployment or other procedural adverse events occurred; three patients (25.0%) had severe post-procedural complications. Clinical success was achieved in 10 patients (83.3%), with 5 (50.0%) resuming chemotherapy after the procedure. Median post-procedural hospital stay was 9 (1–20) days and median overall survival was 47.5 (2–270) days. Conclusions EUS-EC was a feasible technique and could be considered a possible alternative to standard approaches for MIO in highly selected patients. [ABSTRACT FROM AUTHOR]

Simple Summary: This study investigates a simple and cost-effective method to differentiate between mucinous and non-mucinous pancreatic cystic lesions (PCLs) during EUS–FNA. The proper identification of these lesions is crucial to ensure appropriate treatment. Current methods can be invasive or expensive; therefore, this research aims to validate the accuracy of using a conventional glucometer to measure glucose levels directly from the cyst fluid. The study found that glucose levels below 50 mg/dL were highly accurate in identifying mucinous PCLs. These findings could improve diagnostic protocols, providing a faster and more accessible way to effectively manage PCLs. Background: Pancreatic cystic lesions (PCLs) are frequently detected incidentally and vary from benign to malignant. Accurate differentiation between mucinous (M-PCLs) and non-mucinous PCLs (NM-PCLs) is essential for appropriate management. This study aims to validate the accuracy of on-site glucose measurement using a glucometer with a cut-off of 50 mg/dL for distinguishing M-PCLs from NM-PCLs. Methods: In this prospective multicenter study, conducted at three European academic hospitals, patients who underwent endoscopic ultrasound-guided fine-needle aspiration for PCLs between 2019 and 2020 were included. On-site glucose measurement was performed using a conventional glucometer. Data on demographics, clinical features, EUS findings, and histopathology were collected. Results: Fifty patients were enrolled, with 37 having glucose levels < 50 mg/dL and 13 ≥ 50 mg/dL. M-PCLs were more common in the <50 mg/dL group (81%) compared to the ≥50 mg/dL group (23%, p < 0.001). The median CEA was higher in the <50 mg/dL group (146 ng/mL) than in the ≥50 mg/dL group (3 ng/mL, p = 0.047). On-site glucose testing < 50 mg/dl demonstrated a sensitivity of 93.2%, a specificity of 76.5%, and an accuracy of 89% for detecting M-PCLs with an AUC of 0.74 and an OR of 14.29 (p < 0.001). In comparison, CEA > 192 ng/mL had a sensitivity of 55.6%, a specificity of 87.5%, and an accuracy of 75.8% for M-PCLs, with an AUC of 0.65 and an OR of 4.44. Conclusions: On-site glucose measurement using a glucometer with a cut-off of <50 mg/dL is a highly accurate, rapid, and cost-effective method for differentiating M-PCLs from NM-PCLs. Our results validate the glucose cut-off in a multicentric prospective cohort supporting its integration into standard diagnostic protocols for PCLs. [ABSTRACT FROM AUTHOR]

Background We assessed efficacy and safety of endoscopic ultrasound-guided biliary drainage (EUS-BD) vs. endoscopic retrograde cholangiopancreatography (ERCP) as first-line intervention in malignant distal biliary obstruction (MDBO). Methods PubMed/Medline, Embase, and Cochrane databases were searched until 01 /12 /2023 for randomized controlled trials of EUS-BD vs. ERCP for primary biliary drainage in patients with inoperable MDBO. The primary outcome was technical success. Secondary outcomes were clinical success, adverse events, mean procedure time, 1-year stent patency, and overall survival. Relative risk (RR) with 95 %CI were calculated using a random effects model. Results Five studies (519 patients) were included. RR (95 %CI) for EUS-BD was 1.06 (0.96 to 1.17; P = 0.27) for pooled technical success and 1.02 (0.97 to 1.08; P = 0.45) for clinical success. 1-year stent patency was similar between the groups (RR 1.15, 0.94 to 1.42; P = 0.17), with lower reintervention with EUS-BD (RR 0.58, 0.37 to 0.9; P = 0.01). The RR was 0.85 (0.49 to 1.46; P = 0.55) for adverse events and 0.97 (0.10 to 0.17; P = 0.98) for severe adverse events. On subgroup analysis, EUS-guided placement of lumen-apposing metal stent (LAMS) outperformed ERCP in terms of technical success (RR 1.17, 1.01 to 1.35; P = 0.03). Procedure time was lower with EUS-BD (standardized mean difference –2.36 minutes [–2.68 to –2.05; P < 0.001]). Conclusions EUS-BD showed a statistically significant lower reintervention rate than ERCP, but with similar technical success, stent patency, clinical success, and safety. Technical success of EUS-BD with LAMS was better than ERCP. [ABSTRACT FROM AUTHOR]

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). 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.

Due to their aspecific macroscopic appearance, uncommon pancreatic cystic lesions (PCLs) are often misdiagnosed as mucinous lesions and improperly resected. We aimed to evaluate the endoscopic ultrasound (EUS)-guided through-the-needle biopsy (TTNB) capacity of the preoperative diagnosis of uncommon PCLs. Overall, 136 patients with PCLs who underwent EUS-TTNB between 2016 and 2022 were retrospectively identified. Common histotypes (e.g., IPMN, serous cystadenoma, and mucinous cystadenoma) were excluded and 26 (19.1%) patients (15 female, mean age 52.9 ± 10.4) were analyzed. The EUS findings, adverse events (AEs), and TTNB outcomes in uncommon PCLs were evaluated. The cysts histotype was accurately diagnosed by TTNB in 24/26 (92.3%) cases (seven cystic neuroendocrine tumors, four squamoid cysts, three acinar cells cystadenomas, two lymphoepithelial cysts, two mucinous non-neoplastic cysts, two bronchogenic cysts, two cystic lymphangiomas, one solid-pseudopapillary neoplasm, and one schwannoma). In the remaining two cases, lymphangioma was eventually diagnosed after resection. Surgery was performed in 15/26 (57.7%) patients. The mean follow-up of non-surgical patients was 32.5 months. One severe acute case of pancreatitis (3.8%) that required surgery occurred after EUS-TTNB. Uncommon pancreatic/peripancreatic lesions represent the 19.1% of PCLs in our series, with mainly benign histotypes. TTNB demonstrated a high diagnostic performance with a low rate of AEs in this setting, representing a reliable tool with which to avoid useless surgery.

Pancreatic fluid collections (PFCs), including pancreatic pseudocysts (PPs) and walled-off pancreatic necrosis (WON), are common complications of pancreatitis and pancreatic surgery. Historically, the treatment of these conditions has relied on surgical and radiological approaches. The treatment of patients with PFCs has already focused toward an endoscopy-based approach, and with the development of dedicated lumen-apposing metal stents (LAMS), it has almost totally shifted towards interventional Endoscopic Ultrasound (EUS)-guided procedures. However, there is still limited consensus on several aspects of PFCs treatment within the multidisciplinary management. The interventional endoscopy and ultrasound (i-EUS) group is an Italian network of clinicians and scientists with special interest in biliopancreatic interventional endoscopy, especially interventional EUS. This manuscript focuses on the second part of the results of a consensus conference organized by i-EUS, with the aim of providing evidence-based guidance on several intra- and post-procedural aspects of PFCs drainage, such as clinical management and follow-up. [ABSTRACT FROM AUTHOR]

Pancreatic fluid collections (PFCs), including pancreatic pseudocysts (PPs) and walled-off pancreatic necrosis (WON), are common complications of pancreatitis and pancreatic surgery. Historically, the treatment of these conditions has relied on surgical and radiological approaches; however, it has later shifted toward an endoscopy-based approach. With the development of dedicated lumen-apposing metal stents (LAMS), interventional Endoscopic Ultrasound (EUS)-guided procedures have become the standard approach for PFC drainage. However, there is still limited consensus on several aspects of the multidisciplinary management of PFCs. The interventional endoscopy and ultrasound (i-EUS) group is an Italian network of clinicians and scientists with special interest in biliopancreatic interventional endoscopy, especially interventional EUS. This manuscript describes the first part of the results of a consensus conference organized by i-EUS with the aim of providing evidence-based guidance on aspects such as indications for treating PFCs, the timing of intervention, and different technical strategies for managing patients with PFCs. [ABSTRACT FROM AUTHOR]

Simple Summary: The aim of our retrospective study was to compare EUS-guided gastroenteroanastomosis (EUS-GE) and enteral stenting (ES) for the palliation of gastric outlet obstruction (GOO) in patients already treated with EUS-guided choledocoduodenostomy (EUS-CDS) for distal malignant biliary obstruction (DMBO). Our results on 77 patients demonstrated that both EUS-GE and ES are safe and effective for palliation of GOO, but EUS-GE is associated with less recurrence of symptoms. Background: EUS-guided gastroenterostomy (EUS-GE) is a novel and effective procedure for the management of malignant gastric outlet obstruction (GOO) with more durable results when compared to enteral stenting (ES). However, data comparing EUS-GE to ES in patients already treated with EUS-guided choledocoduodenostomy (EUS-CDS) for distal malignant biliary obstruction (DMBO) are lacking. We aimed to compare outcomes of EUS-GE and ES for the palliation of GOO in this specific population of patients. Methods: A multicenter, retrospective analysis of patients with DMBO treated by EUS-CDS and subsequent GOO treated by EUS-GE or ES from 2016 to 2021 was conducted. Primary outcomes were overall AEs rate and dysfunction of the EUS-CDS after GOO treatment. Secondary outcomes included clinical success, technical success, procedure duration, length of hospital stay and relapse of GOO symptoms. Results: A total of 77 consecutive patients were included in the study: 25 patients underwent EUS-GE and 52 underwent ES. AEs rate and patency outcomes of the EUS-CDS after GOO treatment were comparable between the two groups (12.5% vs. 17.3%; p = 0.74). No recurrence of GOO symptoms was registered in the EUS-GE group while 11.5% of ES patients had symptoms recurrence, even if not statistically significant (p = 0.16), after a mean follow-up period of 63.5 days. Conclusion: EUS-GE and ES are both effective and safe for the palliation of GOO in patients already treated by EUS-CDS for DMBO with no difference in the biliary stent dysfunction rate and overall AEs. EUS-GE is associated with less recurrence of GOO symptoms. [ABSTRACT FROM AUTHOR]

Background and study aims Endoscopic ultrasonography (EUS) is a reliable and efficient modality for detecting pancreatic tumors; however, plain EUS (P-EUS) is limited with respect to characterization of pancreatic tumors. Recently, the use of contrast-enhanced harmonic EUS (CH-EUS) has increased, and its utility for characterization of pancreatic tumors has been reported. This meta-analysis compares the diagnostic ability of P-EUS with that of CH-EUS for characterization of pancreatic tumors. Methods A systematic meta-analysis of all potentially relevant articles in PubMed, the Cochrane library, and Google Scholar databases was performed. Fixed effects or random effects models were used to investigate pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio, with 95 % confidence intervals (CIs). Results This meta-analysis included 719 patients who underwent CH-EUS and 723 who underwent P-EUS, from six eligible studies. The pooled estimates of sensitivity, specificity, and diagnostic odds ratio were 93 % (95 % CI, 0.90–0.95), 80 % (95 % CI, 0.75–0.85), and 57.9 (95 % CI, 25.9–130), respectively, for CH-EUS, and 86 % (95 % CI, 0.82–0.89), 59 % (95 % CI, 0.52–0.65), and 8.3 (95 % CI, 2.8–24.5) for P-EUS. The areas under the summary receiver operating characteristics curves for CH-EUS and P-EUS were 0.96 and 0.80, respectively. The diagnostic odds ratio for pancreatic cancer was 2.98 times higher on CH-EUS than on P-EUS (P = 0.03). Funnel plots demonstrated no publication bias. Conclusions This meta-analysis demonstrates that CH-EUS has higher diagnostic accuracy for pancreatic cancer than P-EUS, and is thus a valuable tool for characterization of pancreatic tumors.

Background/Aims: Endoscopic ultrasound (EUS)-guided tissue acquisition is widely utilized as a diagnostic modality for intra-abdominal masses, but there remains debate regarding which suction technique, slow pull (SP) or conventional suction (CS), is better. A meta-analysis of reported studies was conducted to compare the diagnostic yields of SP and CS during EUS-guided tissue acquisition. Methods: We conducted a systematic electronic search using MEDLINE/PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials to identify clinical studies comparing SP and CS. We meta-analyzed accuracy, sensitivity, blood contamination and cellularity using the random-effects model. Results: A total of 17 studies (seven randomized controlled trials, four prospective studies, and six retrospective studies) with 1,616 cases were included in the analysis. Compared to CS, there was a trend toward better accuracy (odds ratio [OR], 1.48; 95% confidence interval [CI], 0.97 to 2.27; p=0.07) and sensitivity (OR, 1.67; 95% CI, 0.95 to 2.93; p=0.08) with SP and a significantly lower rate of blood contamination (OR, 0.48; 95% CI, 0.33 to 0.69; p