Adverse events with endoscopic ultrasound-guided gastroenterostomy for gastric outlet obstruction-A systematic review and meta-analysis.

BACKGROUND: The technical and clinical effectiveness of endoscopic ultrasonography (EUS)-guided gastroenterostomy (GE) has been reported by several meta-analyses, but few of them have addressed the adverse events (AE). The goal of the current meta-analysis was to analyze the AEs associated with various types of EUS-GE. METHODS: All relevant studies reporting the AEs with EUS-GE were searched from 2000 to 31st March 2023 in MEDLINE, Embase, and Scopus. The event rates were pooled using a random effects model. RESULTS: A total of 36 studies (n = 1846) were included in the meta-analysis. The present meta-analysis reports a pooled technical success rate of 96.9% (95.9-98.0; I2 = 29.3%) with a pooled clinical success rate of 90.6% (88.5-92.7; I2 = 60.9%). The pooled incidence of overall AEs with EUS-GE was 13.0% (10.3-15.7; I2 = 69.7%), with the commonest being maldeployment of the stent, seen in 4.6% (3.2-6.0; I2 = 50.6%). The pooled incidences of serious AE and procedure-related mortality were 1.2% (0.7-1.8; I2 = 1.9%) and 0.3% (0.0-0.7; I2 = 0.0%), respectively. Subgroup analysis of studies using only the free-hand technique showed a significantly lower overall AE and maldeployment but not serious AE and other individual AEs. The pooled incidences of delayed stent migration and stent occlusion were 0.5% (0.0-1.1; I2 = 0.0%) and 0.8% (0.2-1.3; I2 = 0.0%), respectively. CONCLUSION: Despite a technical and clinical success rate of >90%, AEs are seen in around one-seventh of the cases of EUS-GE, maldeployment being the commonest. However, the pooled incidence of serious AE and mortality remains low, which is reassuring.

Lumen-apposing metal stents: A primer on indications and technical tips.

Lumen-apposing metal stents have ushered a new frontier for interventional endoscopic ultrasound. Initial use for the drainage of pancreatic fluid collections has rapidly expanded to the bile duct, gallbladder and small bowel. Intra-luminal applications for short strictures have also emerged. Electrocautery enhancement has made the stent delivery speedy. While the advent of lumen-apposing metal stents (LAMS) has brought a paradigm shift in the practice of interventional endoscopic ultrasound, their use is associated with certain technicalities that any advanced endosonologist should know. Understanding indications for LAMS is critical and their use in appropriate settings. Troubleshooting in tricky situations is always a challenge and the background considerations for their use include knowing the target organ, cautery and puncture technique, managing partially opened LAMS and also managing maldeployment. In this review, we discuss the intricacies and technical tips for the use of lumen-apposing metal stents.

Tata Memorial Centre Evidence Based Management of Colorectal cancer.

ABSTRACT: This review article examines the evidence-based management of colorectal cancers, focusing on topics characterized by ongoing debates and evolving evidence. To contribute to the scientific discourse, we intentionally exclude subjects with established guidelines, concentrating instead on areas where the current understanding is dynamic. Our analysis encompasses a thorough exploration of critical themes, including the evidence surrounding complete mesocolic excision and D3 lymphadenectomy in colon cancers. Additionally, we delve into the evolving landscape of perioperative chemotherapy in both colon and rectal cancers, considering its nuanced role in the context of contemporary treatment strategies. Advancements in surgical techniques are a pivotal aspect of our discussion, with an emphasis on the utilization of minimally invasive approaches such as laparoscopy and robotic surgery in both colon and rectal cancers, including advanced rectal cases. Moving beyond conventional radical procedures, we scrutinize the feasibility and implications of endoscopic resections for small tumors, explore the paradigm of organ preservation in locally advanced rectal cancers, and assess the utility of total neoadjuvant therapy in the current treatment landscape. Our final segment reviews pivotal trials that have significantly influenced the management of colorectal liver and peritoneal metastasis.

Endoscopic retrieval of migrated Foley catheter: A clinical case series.

Use of Foley catheter in patients with ileostomy, for the decompression of large bowel distal to stoma or for the administration of large bowel enema through colostomy, either to treat constipation or for bowel preparation prior to colonoscopy, is a common practice. Accidental migration of catheter during bowel irrigation through stoma can take place if it is not secured externally to the skin. We present 2 such cases with intra-colonic migration of Foley catheter that occurred during bowel irrigation and were retrieved endoscopically. To our knowledge, this is the first case report of endoscopic removal of Foley catheter that migrated internally through the stoma.

Current paradigm of endoscopic ultrasound in biliary and pancreatic duct drainage: an update.

Endoscopic retrograde cholangiopancreatography (ERCP) is the workhorse for biliary and pancreatic ductal interventions. Despite advances in both endoscopes and accessories for ERCP, it still has limitations in the presence of altered anatomy, luminal obstruction hindering access to the papilla, and proximal duct obstructions by tight stricture, calculi or intraductal growth. Endoscopic ultrasound-guided biliary drainage (EUS-BD) and EUS-guided pancreatic duct drainage (EUS-PDD) have expanded the rescue procedures after failed ERCP. This review discusses the techniques and results of various EUS-BD procedures, as well as EUS-PDD.

Single-use accessories and endoscopes in the era of sustainability and climate change-A balancing act.

Gastrointestinal (GI) endoscopy is among the highest waste generator in healthcare facilities. The major reasons include production of large-volume non-renewable waste, use of single-use devices, and reprocessing or decontamination processes. Single-use endoscopic accessories have gradually replaced reusable devices over last two decades contributing to the rising impact of GI endoscopy on ecosystem. Several reports of infection outbreaks with reusable duodenoscopes raised concerns regarding the efficacy and adherence to standard disinfection protocols. Even the enhanced reprocessing techniques like double high-level disinfection have not been found to be the perfect ways for decontamination of duodenoscopes and therefore, paved the way for the development of single-use duodenoscopes. However, the use of single-use endoscopes is likely to amplify the net waste generated and carbon footprint of any endoscopy unit. Moreover, single-use devices challenge one of the major pillars of sustainability, that is, "reuse." In the era of climate change, a balanced approach is required taking into consideration patient safety as well as financial and environmental implications. The possible solutions to provide optimum care while addressing the impact on climate include selective use of disposable duodenoscopes and careful selection of accessories during a case. Other options include use of disposable endcaps and development of effective high-level disinfection techniques. The collaboration between the healthcare professionals and the manufacturers is paramount for the development of environmental friendly devices with low carbon footprint.

Predictors of proximal migration of straight biliary plastic stents.

BACKGROUND/AIMS: Proximal biliary plastic stent migration (PSM) remains a challenging complication. The study aims at determining the PSM rate, retrieval outcomes and factors associated with PSM. METHODS: Endoscopy database was analyzed from January 2016 to January 2021 to identify 1137 patients, who underwent stent removal or repeat endoscopic retrograde cholangiopancreatography (ERCP). Demography, methods of stent retrieval, outcomes and complications were noted. Logistic regression was performed to determine risk factors for PSM. Propensity score matching was done in a 1:1 manner using age, sex, comorbidities and indication to assess endoscopy-related factors. Clinical trial registration done (CTRI/2022/02/040516). RESULTS: PSM was noted in 74 (6.5%) cases. Stent retrieval was successful in 94.59% (70/74) of cases. A balloon catheter (46/74) was commonly used. Technical failure was due to an impacted stent (2) and stent above the stricture (2). Complications were seen in 2.7% of cases. On multi-variate regression, sphincteroplasty at index ERCP (Odds ratio [OR] = 5.68, 95% confidence interval [CI] = 2.7-11.89), stent length < 10 cm (OR = 8.53, 95% CI = 3.2-22.47), 7-Fr stent (OR = 18.25, 95% CI = 6.5-50.64), dilated bile duct (mean diameter- 9.2 ± 3.94 mm) (OR = 0.384, 95% CI = 0.18-0.72) and delayed ERCP by > 3 months from index ERCP (OR = 15.28, 95% CI = 8.1-28.49). After performing propensity score matching for age, sex, comorbidities and indication to determine endoscopy-related factors, 7-Fr stent size (OR 3.495; 95% CI-1.23-9.93) and duration of indwelling stent for more than three months (OR-3.37; 95% CI-1.646-6.76) were significantly associated with proximal stent migration. CONCLUSION: Proximally migrated straight stents can be successfully retrieved using standard accessories. The use of 7-Fr size stent, stents indwelling for more than three months, sphincteroplasty at index ERCP, stent length < 10 cm and dilated bile duct were associated with increased risk of proximal migration of straight biliary plastic stents. After propensity score matching, the use of 7-Fr size stents and stent indwelling for over three months were endoscopy-related factors associated with proximal migration.

Role of endoscopic ultrasound-guided tissue acquisition for the diagnosis of gastric wall thickening: a retrospective study with meta-analysis.

Background: Tissue acquisition from a thickened gastric wall using biopsy forceps may not always lead to diagnosis, given the submucosal location of the pathology. Endoscopic ultrasound (EUS)-guided tissue acquisition (TA) may serve as a minimally invasive diagnostic tool in such cases. Hence, we aimed to assess the diagnostic outcome and safety of EUS-TA from thickened gastric walls. Methods: Data from patients with gastric wall thickening undergoing EUS-TA at 5 tertiary care centers from August 2020 to August 2022 were retrospectively analyzed. These data were pooled with studies obtained from a comprehensive search of Medline, Embase and Scopus from January 2000 to November 2022 and a meta-analysis was performed. Pooled event rates were calculated using an inverse variance model. Results: The search strategy yielded 13 studies that were combined with data from 30 patients from our centers; a total of 399 patients were included in the analysis. The pooled rate of sample adequacy was 94.1% (95% confidence interval [CI] 90.0-98.2), while the pooled rate of diagnostic accuracy was 91.3% (95%CI 87.0-95.5). The pooled sensitivity and specificity for diagnosing malignant lesions with EUS-TA from gastric wall thickening were 94.8% (95%CI 91.3-97.2) and 100% (95%CI 93.6-100), respectively. There were no reported adverse events in any of the studies. Conclusions: EUS-TA offers a safe and accurate diagnostic modality for the etiological diagnosis of thickened gastric walls. Further research is required to identify the needle type and optimal technique for improving outcomes.

Diagnostic efficacy of endoscopic ultrasound-guided liver biopsy for diffuse liver diseases and its predictors - a multicentric retrospective analysis.

Aim of the study: Endoscopic ultrasound (EUS)-guided liver biopsy (LB) has become an increasingly popular method of tissue acquisition for evaluating liver diseases. Despite its advantages, EUS-LB has not been widely adopted in clinical practice due to concerns regarding efficacy and safety. Present data on EUS-LB from India are scarce. We aimed to study the diagnostic outcome and safety of EUS-guided liver biopsy. Material and methods: This is a retrospective analysis of prospectively maintained data from January 2021 to October 2022 of consecutive patients undergoing EUS-LB at four tertiary care centers in India. The primary outcome was sample adequacy, while secondary outcomes were rate of successful pathological diagnoses and incidence of adverse events (AE). Results: A total of 74 patients (median age: 44.5 years, 50.0% males) were included. The majority of the patients underwent left-lobe biopsy (62/74, 83.7%), and a 19-G Franseen FNB needle was most commonly used (61/74, 82.4%). Wet heparin suction was used in most cases (60/74, 81.1%). There were five mild AEs observed (one case of self-limited bleeding and four cases of post-procedural pain). Adequate and optimal samples were obtained in 71 (95.9%) and 49 (66.2%) cases, with a conclusive diagnosis being made in 97.3% (72/74) of the patients. On multivariate analysis, the presence of ascites was a negative predictor of optimal sample (odds ratio [OR] = 0.128, 95% CI: 0.017-0.96). Conclusions: EUS-LB is a safe and viable alternative to percutaneous liver biopsy, achieving diagnosis in > 95% of cases. EUS-LB can be performed safely even in patients with mild ascites, although ascites reduces the chances of getting an optimal sample.

Atezolizumab plus bevacizumab versus lenvatinib as first-line therapy for advanced hepatocellular carcinoma: A systematic review and meta-analysis.

Aim of the study: Studies comparing atezolizumab plus bevacizumab (ATE/BEV) vs. lenvatinib (LEN) for advanced hepatocellular carcinoma (aHCC) have shown conflicting results. With this background, we aimed to collate the available evidence comparing ATE/BEV and LEN in aHCC. Material and methods: A comprehensive search of three databases was conducted from inception to November 2022 for studies comparing ATE/BEV with LEN for managing aHCC. Results were presented with their 95% confidence intervals (95% CI) as the hazard ratio (HR) for time-to-event outcomes or odds ratios (OR) for dichotomous outcomes. Results: A total of 8 studies were included. On analysis of matched cohorts, there was no difference in the objective response rate (ORR) (adjusted odds ratio [aOR] = 1.15, 95% CI: 0.83-1.61) or disease control rate (DCR) (aOR = 0.83, 95% CI: 0.49-1.38) between groups. Three studies reported a significantly longer progression-free survival (PFS) with ATE/LEN, while one reported a longer PFS with LEN. The adjusted hazard ratio (aHR) for PFS available from three studies was comparable (HR = 1.06, 95% CI: 0.75-1.50). Data were insufficient to carry out a formal analysis for overall survival (OS), but none of the studies reported any difference in OS. On comparison of overall adverse events (AE) and ≥ grade 3 AE, there was no difference in the overall analysis, but higher risk of AE with LEN on sensitivity analysis. Conclusions: Based on the currently available literature, LEN was found to be non-inferior to ATE/BEV in terms of ORR, DCR, and PFS. However, LEN may be associated with a higher incidence of AEs. Further head-to-head trials are required to demonstrate the superiority of ATE/BEV over LEN.

IgG4-related disorders of the gastrointestinal tract: Experience from a tertiary care centre with systematic review of Indian literature.

INTRODUCTION: IgG4-related disease (IgG4-RD) is a rare disease entity in India. We aimed at studying the clinical profile of IgG4-RD of gastrointestinal tract (GIT) from our centre, while systematically reviewing data from India. METHODS: Retrospective review of IgG4-RD of GIT was done using electronic medical records between January 2013 and July 2022. Literature search was done for studies of IgG4-RD of the GIT reported from India from 2000 till January 2023. Case series, case reports of IgG4-RD of GIT and case reports describing GIT with multi-organ involvement were included in the review. Primary outcome measure was response to treatment. Secondary outcome measure was relapse after remission. RESULTS: Thirty-one patients were included with 71% (22/31) having autoimmune pancreatitis. The diagnosis was achieved on surgical specimen in 35% (11/31) patients. Steroid was given to 64% (20/31) patients with remission achieved in 70% (14/20) patients. Four patients exhibitted response to prolonged course of steroids with maintenance azathioprine. Relapse was seen in four (20%) patients who achieved remission. Of 731 articles screened, 48 studies (four case series and 44 case reports) were included in the literature review. Of 95 patients described, steroids were given to 65.2% (62/95), while surgery was done in 33.6% (32/95). Remission was seen in 96.6% (85/88) with relapse occurring in 11.4% (10/88) patients on follow-up. CONCLUSION: One-third patients of IgG4-RD of GIT are diagnosed after surgery. Response to steroids is good with relapse occurring in up to 12% patients.

Efficacy of lumen-apposing metal stents for the management of benign gastrointestinal stricture: a systematic review and meta-analysis.

Background: Lumen-apposing metal stents (LAMS) are an evolving option for the management of benign gastrointestinal (GI) strictures. Multiple studies have reported on the efficacy and safety of LAMS for benign GI strictures, but were limited by their small sample size. Hence, we conducted this meta-analysis to assess the critical role of LAMS for the management of benign GI strictures. Methods: A literature search of various databases from inception until October 2022 was conducted for studies evaluating the outcome of LAMS in patients with benign GI strictures. The outcomes assessed included technical and clinical success, adverse events including stent migration, and reintervention. Pooled event rates across studies were expressed with summative statistics. Results: A total of 18 studies (527 patients) were included in the present analysis. The pooled event rates for technical, short-term and long-term clinical success were 99.9% (95% confidence interval [CI] 99.1-100.0), 93.9% (95%CI 90.7-100.0), and 72.8% (95%CI 55.7-90.0), respectively. The pooled incidence of adverse events and stent migration with LAMS for benign GI strictures was 13.5% (95%CI 8.6-18.5) and 10.6% (95%CI 6.0-15.2), respectively. The pooled event rate for reintervention with LAMS for GI strictures was 23.0% (95%CI 15.7-30.3). In a subgroup analysis focusing only on anastomotic strictures there was no significant difference in the pooled event rates for various outcomes. Conclusions: LAMS have a high technical and short-term clinical success rate, with an acceptable safety profile for the management of benign GI strictures. Further studies are needed to determine the appropriate duration of stent therapy and long-term outcomes.

Does a coaxial double pigtail stent reduce adverse events after lumen apposing metal stent placement for pancreatic fluid collections? A systematic review and meta-analysis.

Background: Lumen apposing metal stents (LAMSs) have a higher clinical success rate for managing pancreatic fluid collections. But they are associated with adverse events (AEs) like bleeding, migration, buried stent, occlusion, and infection. It has been hypothesized that placing a double pigtail stent (DPS) within LAMS may mitigate these AEs. The present systematic review and meta-analysis were conducted to compare the outcome and AEs associated with LAMS with or without a coaxial DPS (LAMS-DPS). Methods: A comprehensive literature search of three databases from January 2010 to August 2022 was conducted for studies comparing the outcome and AEs of LAMS alone and LAMS-DPS. Pooled incidence and risk ratios (RRs) with 95% confidence intervals (CIs) were calculated for all the dichotomous outcomes. Results: Overall, eight studies (n = 460) were included in the final analysis. The clinical success rate (RR 1.00, 95% CI: 0.87-1.14) and the risk of overall AEs (RR 1.60, 95% CI: 0.95-2.68) remained comparable between both groups. There was no difference in the risk of bleeding between LAMS alone and LAMS-DPS (RR 1.80, 95% CI: 0.83-3.88). Individual analysis of other AEs, including infection, stent migration, occlusion, and reintervention, showed no difference in the risk between both procedures. Conclusion: The present meta-analysis shows that coaxial DPS within LAMS may not reduce AE rates or improve clinical outcomes. Further larger studies, including patients with walled-off necrosis, are required to demonstrate the benefit of coaxial DPS within LAMS.

Maternal and fetal outcomes in pregnant patients with non-cirrhotic portal hypertension: A systematic review and meta-analysis.

Background: Concerned studies with respect to the outcome of pregnant patients with non-cirrhotic portal hypertension are limited. Thus, a systematic review and meta-analysis of the available literature was conducted. Methods: A literature search was conducted from 1999 to December 2021 for studies evaluating pregnancy outcomes in patients with non-cirrhotic portal hypertension. Results: Twelve studies were included in the meta-analysis. The pooled rate of variceal bleeding, ascites and severe anemia requiring blood transfusion were 9.6%, 2.3%, and 14.9%, respectively. The pooled rate of spontaneous miscarriage, gestational hypertension, delivery by cesarean section, and postpartum hemorrhage were 11.9%, 4.5%, 36.7%, and 4.7%, respectively. The pooled stillbirth rate was 2.5% and among the live births, the pooled rates of preterm birth, low birth weight, intensive care unit admission, and neonatal mortality were 21.6%, 18.7%, 15.5%, and 1.8%, respectively. Conclusion: Pregnancy in patients with non-cirrhotic portal hypertension is associated with increased maternal & fetal morbidity but mortality remains low.

Comparison of suction techniques for EUS-guided tissue acquisition: Systematic review and network meta-analysis of randomized controlled trials.

Background and study aims Despite the widespread use of endoscopic ultrasound (EUS)-guided tissue acquisition, the choice of optimal suction technique remains a subject of debate. Multiple studies have shown conflicting results with respect to the four suction techniques: Dry suction (DS), no suction (NS), stylet slow-pull (SSP) and wet suction (WS). Thus, the present network meta-analysis (NMA) was conducted to compare the diagnostic yields of above suction techniques during EUS-guided tissue acquisition. Methods A comprehensive literature search from 2010 to March 2022 was done for randomized trials comparing the aspirated sample and diagnostic outcome with various suction techniques. Both pairwise and network meta-analyses were performed to analyze the outcomes: sample adequacy, moderate to high cellularity, gross bloodiness and diagnostic accuracy. Results A total of 16 studies (n=2048 patients) were included in the final NMA. WS was associated with a lower odd of gross bloodiness compared to DS (odds ratio 0.50, 95% confidence interval 0.24-0.97). There was no significant difference between the various suction methods with respect to sample adequacy, moderate to high cellularity and diagnostic accuracy. On meta-regression, to adjust for the effect of needle type, WS was comparable to DS in terms of bloodiness when adjusted for fine-needle aspiration needle. Surface under the cumulative ranking analysis ranked WS as the best modality for all the outcomes. Conclusions The present NMA did not show superiority of any specific suction technique for EUS-guided tissue sampling with regard to sample quality or diagnostic accuracy, with low confidence in estimates.

Prothrombotic states in portal vein thrombosis and Budd-Chiari syndrome in India: A systematic review and meta-analysis.

BACKGROUND: Both Budd-Chiari syndrome (BCS) and portal vein thrombosis (PVT) have been linked to various prothrombotic (PT) conditions. The PT profile in Asians is different from the west and there are no nationwide epidemiological surveys from India. Hence, the present meta-analysis was aimed at analyzing the prevalence of acquired and hereditary thrombophilia among Indian patients with non-cirrhotic PVT and BCS. METHODS: A comprehensive literature search of Embase, Medline and Scopus was conducted from January 2000 to February 2022 for studies evaluating the prevalence of various PT conditions in Indian patients with PVT and BCS. Pooled prevalence rates across studies were expressed with summative statistics. RESULTS: Thirty-five studies with 1005 PVT patients and 1391 BCS patients were included in the meta-analysis. At least one PT condition was seen in 46.2% (28.7-63.7) of the PVT patients and 44.9% (37.3-60.7) of the BCS patients. Multiple PT conditions were seen in 13.0% (4.2-21.8) of the PVT patients and 7.9% (3.5-12.4) of the BCS patients. Among PVT patients, hyperhomocysteinemia was the commonest prothrombotic condition (21.6%) followed by protein C (PC) deficiency (10.7%), Janus kinase 2 (JAK-2) mutation (8.5%) and antiphospholipid antibodies (APLA) (7.5%). Among patients with BCS, PC deficiency was the commonest prothrombotic condition (10.6%) followed by methylenetetrahydrofolate reductase (MTHFR) mutation (9.8%), APLA (9.7%) and JAK-2 mutation (9.1%). CONCLUSION: The PT profile in Indian patients with abdominal vein thrombosis is different from that of the western data with a lower prevalence of PT conditions in patients with BCS.

Adverse events with EUS-guided biliary drainage: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Multiple meta-analyses have evaluated the technical and clinical success of EUS-guided biliary drainage (BD), but meta-analyses concerning adverse events (AEs) are limited. The present meta-analysis analyzed AEs associated with various types of EUS-BD. METHODS: A literature search of MEDLINE, Embase, and Scopus was conducted from 2005 to September 2022 for studies analyzing the outcome of EUS-BD. The primary outcomes were incidence of overall AEs, major AEs, procedure-related mortality, and reintervention. The event rates were pooled using a random-effects model. RESULTS: One hundred fifty-five studies (7887 patients) were included in the final analysis. The pooled clinical success rates and incidence of AEs with EUS-BD were 95% (95% confidence interval [CI], 94.1-95.9) and 13.7% (95% CI, 12.3-15.0), respectively. Among early AEs, bile leak was the most common followed by cholangitis with pooled incidences of 2.2% (95% CI, 1.8-2.7) and 1.0% (95% CI, .8-1.3), respectively. The pooled incidences of major AEs and procedure-related mortality with EUS-BD were .6% (95% CI, .3-.9) and .1% (95% CI, .0-.4), respectively. The pooled incidences of delayed migration and stent occlusion were 1.7% (95% CI, 1.1-2.3) and 11.0% (95% CI, 9.3-12.8), respectively. The pooled event rate for reintervention (for stent migration or occlusion) after EUS-BD was 16.2% (95% CI, 14.0-18.3; I2 = 77.5%). CONCLUSIONS: Despite a high clinical success rate, EUS-BD may be associated with AEs in one-seventh of the cases. However, major AEs and mortality incidence remain less than 1%, which is reassuring.

Study protocol for a multicenter randomized controlled trial to compare radiofrequency ablation with surgical resection for treatment of pancreatic insulinoma.

BACKGROUND: Insulinoma is the most common functional pancreatic neuroendocrine tumor and treatment is required to address symptoms associated with insulin hypersecretion. Surgical resection is effective but burdened by high rate of adverse events (AEs). Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) demonstrated encouraging results in terms of safety and efficacy for the management of these tumors. However, studies comparing surgery and EUS-RFA are lacking. AIMS: The primary aim is to compare EUS-RFA with surgery in term of safety (overall rate of AEs). Secondary endpoints include: (a) severe AEs rate; (b) clinical effectiveness; (c) patient's quality of life; (d) length of hospital stay; (e) rate of local/distance recurrence; (f) need of reintervention; (g) rate of endocrine and exocrine pancreatic insufficiency; (h) factors associated with EUS-RFA related AEs and clinical effectiveness. METHODS: ERASIN-RCT is an international randomized superiority ongoing trial in four countries. Sixty patients will be randomized in two arms (EUS-RFA vs surgery) and outcomes compared. Two EUS-RFA sessions will be allowed to achieve symptoms resolution. Randomization and data collection will be performed online. DISCUSSION: This study will ascertain if EUS-RFA can become the first-line therapy for management of small, sporadic, pancreatic insulinoma and be included in a step-up approach in case of clinical failure.