International Consensus Recommendations for Safe Use of LAMS for On- and Off-Label Indications Using a Modified Delphi Process.

INTRODUCTION: The study aimed to develop international consensus recommendations on the safe use of lumen-apposing metal stents (LAMSs) for on- and off-label indications. METHODS: Based on the available literature, statements were formulated and grouped into the following categories: general safety measures, peripancreatic fluid collections, endoscopic ultrasound (EUS)-biliary drainage, EUS-gallbladder drainage, EUS-gastroenterostomy, and gastric access temporary for endoscopy. The evidence level of each statement was determined using the Grading of Recommendations Assessment, Development, and Evaluation methodology.International LAMS experts were invited to participate in a modified Delphi process. When no 80% consensus was reached, the statement was modified based on expert feedback. Statements were rejected if no consensus was reached after the third Delphi round. RESULTS: Fifty-six (93.3%) of 60 formulated statements were accepted, of which 35 (58.3%) in the first round. Consensus was reached on the optimal learning path, preprocedural imaging, the need for airway protection and essential safety measures during the procedure, such as the use of Doppler, and measurement of the distance between the gastrointestinal lumen and the target structure. Specific consensus recommendations were generated for the different LAMS indications, covering, among others, careful patient selection, the preferred size of the LAMS, the need for antibiotics, the preferred anatomic location of the LAMS, the need for coaxial pigtail placement, and the appropriate management of LAMS-related adverse events. DISCUSSION: Through a modified international Delphi process, we developed general and indication-specific experience- and evidence-based recommendations on the safe use of LAMS.

Managing dysfunctions and reinterventions in endoscopic ultrasound-guided choledochoduodenostomy with lumen apposing metal stents: Illustrated technical review (with videos).

Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) with lumen apposing metal stent is emerging both as a rescue strategy and a primary treatment for distal malignant biliary obstruction. The large-scale diffusion of the procedure and improved overall survival of patients with pancreatobiliary neoplasms is resulting in a growing population of long-term EUS-CDS lumen apposing metal stent carriers. Recent studies have reported a need for reintervention during follow-up as high as 55%, and the Leuven-Amsterdam-Milan Study Group classification has been developed, identifying five mechanisms of stent dysfunction and 11 possible rescue strategies aimed at restoring biliary drainage. This illustrated technical review aims to further dissect the recent classification through a comprehensive analysis of nine illustrative cases, offering insights into the pathophysiology underlying dysfunction and clinical reasoning behind rescue interventions, as well as technical considerations and practical tips and tricks. By exploring mechanisms of dysfunction, this review also assists clinicians in selecting the ideal candidates for EUS-CDS while identifying patients deemed high risk for dysfunction or clinical failure.

Training in basic gastrointestinal endoscopic procedures: a European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) Position Statement.

This ESGE Position Statement provides structured and evidence-based guidance on the essential requirements and processes involved in training in basic gastrointestinal (GI) endoscopic procedures. The document outlines definitions; competencies required, and means to their assessment and maintenance; the structure and requirements of training programs; patient safety and medicolegal issues. 1: ESGE and ESGENA define basic endoscopic procedures as those procedures that are commonly indicated, generally accessible, and expected to be mastered (technically and cognitively) by the end of any core training program in gastrointestinal endoscopy. 2: ESGE and ESGENA consider the following as basic endoscopic procedures: diagnostic upper and lower GI endoscopy, as well as a limited range of interventions such as: tissue acquisition via cold biopsy forceps, polypectomy for lesions ≤ 10 mm, hemostasis techniques, enteral feeding tube placement, foreign body retrieval, dilation of simple esophageal strictures, and India ink tattooing of lesion location. 3: ESGE and ESGENA recommend that training in GI endoscopy should be subject to stringent formal requirements that ensure all ESGE key performance indicators (KPIs) are met. 4: Training in basic endoscopic procedures is a complex process and includes the development and acquisition of cognitive, technical/motor, and integrative skills. Therefore, ESGE and ESGENA recommend the use of validated tools to track the development of skills and assess competence. 5: ESGE and ESGENA recommend incorporating a multimodal approach to evaluating competence in basic GI endoscopic procedures, including procedural thresholds and the measurement and documentation of established ESGE KPIs. 7: ESGE and ESGENA recommend the continuous monitoring of ESGE KPIs during GI endoscopy training to ensure the trainee's maintenance of competence. 9: ESGE and ESGENA recommend that GI endoscopy training units fulfil the ESGE KPIs for endoscopy units and, furthermore, be capable of providing the dedicated personnel, infrastructure, and sufficient case volume required for successful training within a structured training program. 10: ESGE and ESGENA recommend that trainers in basic GI endoscopic procedures should be endoscopists with formal educational training in the teaching of endoscopy, which allows them to successfully and safely teach trainees.

PERcutaneous transhepatic CHOLangioscopy using a new single-operator short cholangioscope (PERCHOL): European feasibility study.

OBJECTIVES: A new short device for percutaneous endoscopic cholangioscopy was recently developed. However, feasibility and safety has not yet been evaluated. The aim of this study was to assess clinical success, technical success, and adverse events (AEs). METHODS: This observational multicenter retrospective study included all patients who underwent percutaneous cholangioscopy using a short cholangioscope between 2020 and 2022. The clinical success, defined as the complete duct clearance or obtaining at least one cholangioscopy-guided biopsy, was assessed. The histopathological accuracy, technical success, and the AE rate were also evaluated. RESULTS: Fifty-one patients (60 ± 15 years, 45.1% male) were included. The majority of patients had altered anatomy (n = 40, 78.4%), and biliary stones (n = 34, 66.7%) was the commonest indication. The technique was predominantly wire-guided (n = 44, 86.3%) through a percutaneous sheath (n = 36, 70.6%) following a median interval of 8.5 days from percutaneous drainage. Cholangioscopy-guided electrohydraulic lithotripsy was performed in 29 cases (56.9%), combined with a retrieval basket in eight cases (27.6%). The clinical success was 96.6%, requiring a median of one session (range 1-3). Seventeen patients (33.3%) underwent cholangioscopy-guided biopsies. There were four (7.8%) cholangioscopy-related AEs (cholangitis and peritonitis). Overall, the technical success and AE rates were 100% and 19.6%, respectively, in a median follow-up of 7 months. CONCLUSION: Percutaneous endoscopic cholangioscopy with a new short device is effective and safe, requiring a low number of sessions to achieve duct clearance or accurate histopathological diagnosis.

EUS-guided gastroenterostomy for management of malignant gastric outlet obstruction: a prospective cohort study with matched comparison with enteral stenting.

BACKGROUND AND AIMS: Retrospective studies on malignant gastric outlet obstruction (mGOO) highlighted several advantages of EUS-guided gastroenterostomy (EUS-GE) over enteral stenting (ES). However, no prospective evidence is available. The aim of this study was to report on clinical outcomes of EUS-GE in a prospective cohort study, with a subgroup comparison versus ES. METHODS: All consecutive patients endoscopically treated for mGOO between December 2020 and December 2022 in a tertiary, academic center were enrolled in a prospective registry (Prospective Registry of Therapeutic Endoscopic Ultrasound [PROTECT]; NCT04813055) and followed up every 30 days to register efficacy/safety outcomes. EUS-GE and ES cohorts were matched according to baseline frailty and oncologic disease. RESULTS: A total of 104 patients were treated for mGOO during the study; 70 (58.6% male subjects; median age, 64 [interquartile range, 58-73] years; 75.7% pancreatic cancer, 60.0% metastatic cancer) underwent EUS-GE via the wireless simplified technique. Technical success was 97.1% and clinical success was 97.1% after a median of 1.5 (interquartile range, 1-2) days. Adverse events occurred in 9 (12.9%) patients. After a median follow-up of 105 (49-187) days, symptom recurrence was 7.6%. In the matched comparison versus ES (28 patients per arm), EUS-GE-treated patients experienced higher and faster clinical success (100% vs 75.0%, P = .006), reduced recurrences (3.7% vs 33.3%, P = .02), and a trend toward shorter time to chemotherapy. CONCLUSIONS: In this first, prospective, single-center comparison, EUS-GE showed excellent efficacy in treating mGOO, with an acceptable safety profile and long-term patency, and several clinically significant advantages over ES. While awaiting randomized trials, these results might endorse EUS-GE as first-line strategy for mGOO, where adequate expertise is available.

Same-session double EUS-guided bypass versus surgical gastroenterostomy and hepaticojejunostomy: an international multicenter comparison.

BACKGROUND AND AIMS: Gastric outlet and biliary obstruction are common manifestations of GI malignancies and some benign diseases for which standard treatment would be surgical gastroenterostomy and hepaticojejunostomy (ie, "double bypass"). Therapeutic EUS has allowed for the creation of an EUS-guided double bypass. However, same-session double EUS-guided bypass has only been described in small proof-of-concept series and lacks a comparison with surgical double bypass. METHODS: A retrospective multicenter analysis was performed of all consecutive same-session double EUS-guided bypass procedures performed in 5 academic centers. Surgical comparators were extracted from these centers' databases from the same time interval. Efficacy, safety, hospital stay, nutrition and chemotherapy resumption, long-term patency, and survival were compared. RESULTS: Of 154 identified patients, 53 (34.4%) received treatment with EUS and 101 (65.6%) with surgery. At baseline, patients undergoing EUS exhibited higher American Society of Anesthesiologists scores and a higher median Charlson Comorbidity Index (9.0 [interquartile range {IQR}, 7.0-10.0] vs 7.0 [IQR, 5.0-9.0], P < .001). Technical success (96.2% vs 100%, P = .117) and clinical success rates (90.6% vs 82.2%, P = .234) were similar when comparing EUS and surgery. Overall (11.3% vs 34.7%, P = .002) and severe adverse events (3.8% vs 19.8%, P = .007) occurred more frequently in the surgical group. In the EUS group, median time to oral intake (0 days [IQR, 0-1] vs 6 days [IQR, 3-7], P < .001) and hospital stay (4.0 days [IQR, 3-9] vs 13 days [IQR, 9-22], P < .001) were significantly shorter. CONCLUSIONS: Despite being used in a patient population with more comorbidities, same-session double EUS-guided bypass achieved similar technical and clinical success and was associated with fewer overall and severe adverse events when compared with surgical gastroenterostomy and hepaticojejunostomy.

Endoscopic ultrasound-guided gastrointestinal anastomosis: Current status and future perspectives.

OBJECTIVES: Both clinical experience and supporting data have improved drastically in the context of endoscopic ultrasound-guided gastrointestinal anastomosis (EUS-GIA). Where outcomes used to be questioned, focus has now moved towards performing comparative studies, optimizing technical approaches, improving patient selection, and developing well-defined treatment algorithms. METHODS: The purpose of this review is to provide an overview of technical developments within EUS-GIA and to discuss the current status of EUS-GIA and future directions. RESULTS: EUS-GIA techniques such as EUS-guided gastroenterostomy (EUS-GE), EUS-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP) (EDGE) and EUS-guided treatment afferent loop syndrome have undergone further development, refining technical approaches, improving patient selection and subsequent outcomes. Retrospective evaluations of EUS-GE have shown similar safety when compared to enteral stenting, whilst attaining surgical range efficacy. Whereas, in patients with gastric bypass anatomy, EDGE seems less cumbersome and time consuming than enteroscopy-assisted ERCP, while preventing surgical morbidity associated with laparoscopy-assisted ERCP. Although less evidence is available on EUS-guided treatment of afferent loop syndrome, this technique has been associated with higher clinical success and fewer reinterventions and adverse events when compared to enteral stenting and percutaneous drainage, respectively. Several randomized studies are currently underway evaluating EUS-GE in malignant gastric outlet obstruction (GOO), whereas more prospective data are still required on EDGE and long-term fistula management. CONCLUSION: EUS-GIA has become a crucial alternative to established techniques, overcoming technical limitations and subsequently improving patient outcomes. Although we should focus on prospective confirmation of these results in the context of GOO and EDGE, the current evidence already allows for a prominent role for EUS-GIA in our everyday practice.

Current landscape of therapeutic EUS: Changing paradigms in gastroenterology practice.

Therapeutic EUS has witnessed exponential growth in the last decade, but it has been considered investigational until recently. An increasing body of good-quality evidence is now demonstrating clear advantages over established alternatives, adding therapeutic EUS to management algorithms of complex hepato-pancreato-biliary (HPB) and gastrointestinal (GI) conditions. In this review, the available evidence and clinical role of therapeutic EUS in established and evolving applications will be discussed. A Graphical Summary for each scenario will provide (1) technical steps, (2) anatomical sketch, (3) best-supporting evidence, and (4) role in changing current and future GI practice. Therapeutic EUS has accepted well-established applications such as drainage of symptomatic peripancreatic fluid collections, biliary drainage in failed endoscopic retrograde cholangiopancreatography, and treatment of acute cholecystitis in unfit-for-surgery patients. In addition, good-quality evidence on several emerging indications (e.g., treatment of gastric outlet obstruction, local ablation of pancreatic solid lesions, etc.) is promising. Specific emphasis will be given to how these technical innovations have changed management paradigms and algorithms and expanded the possibilities of gastroenterologists to provide therapeutic solutions to old and emerging clinical needs. Therapeutic EUS is cementing its role in everyday practice, radically changing the treatment of different HPB diseases and other conditions (e.g., GI obstruction). The development of dedicated accessories and increased training opportunities will expand the ability of gastroenterologists to deliver highly effective yet minimally invasive therapies, potentially translating into a better quality of life, especially for oncological and fragile patients.

Classification, risk factors, and management of lumen apposing metal stent dysfunction during follow-up of endoscopic ultrasound-guided choledochoduodenostomy: Multicenter evaluation from the Leuven-Amsterdam-Milan Study Group.

OBJECTIVES: Long-term outcomes of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) performed with lumen apposing metal stents (LAMS) have been poorly evaluated in small or retrospective series, leading to an underestimation of LAMS dysfunction. METHODS: All consecutive EUS-CDS performed in three academic referral centers were included in prospectively maintained databases. Technical/clinical success, adverse events (AEs), and dysfunction during follow-up were retrospectively analyzed. Kaplan-Meier analysis was used to estimate dysfunction-free survival (DFS), with Cox proportional hazard regression to evaluate independent predictors of dysfunction. RESULTS: Ninety-three patients were included (male 56%; mean age, 70 years [95% confidence interval (CI) 68-72]; pancreatic cancer 81%, metastatic disease 47%). In 67% of procedures, 6 mm LAMS were used. Technical and clinical success were achieved in 97.8% and 93.4% of patients, respectively, with AEs occurring in 9.7% (78% mild/moderate). Dysfunction occurred in 31.8% of patients after a mean of 166 days (95% CI 91-241), with an estimated 6 month and 12 month DFS of 75% and 52%, respectively; mean DFS of 394 (95% CI 307-482) days. Almost all dysfunctions (96%) were successfully managed by endoscopic reintervention. Duodenal invasion (hazard ratio 2.7 [95% CI 1.1-6.8]) was the only independent predictor of dysfunction. CONCLUSIONS: Endoscopic ultrasound-guided choledochoduodenostomy shows excellent initial efficacy and safety, although stent dysfunctions occurs frequently during long-term follow-up. Almost all stent dysfunctions can be managed successfully by endoscopic reinterventions. We propose a comprehensive classification of the different types of dysfunction that may be encountered and rescue procedures that may be employed under these circumstances. Duodenal invasion seems to increase the risk of developing EUS-CDS dysfunction, potentially representing a relative contraindication for this technique.

Combined endoscopic mAnagement of BiliaRy and gastrIc OutLET obstruction (CABRIOLET Study): A multicenter retrospective analysis.

Objectives: Combined biliary obstruction and gastric outlet obstruction (GOO) represent a challenging clinical scenario despite developments in therapeutic endoscopic ultrasonography (EUS) as GOO might impair EUS-guided biliary drainage. Little is known about the effectiveness of different therapeutic combinations used to treat double obstruction, especially regarding stent patency. Methods: All consecutive patients with double obstruction treated between 2016 and 2021 in three tertiary academic centres were eligible for inclusion. Five combinations involving enteral stenting (ES), EUS-guided gastroenterostomy (EUS-GE), hepaticogastrostomy (EUS-HGS), choledochoduodenostomy (EUS-CDS), and transpapillary biliary stenting (TPS) were evaluated for dysfunction during follow-up, either as proportions or dysfunction-free survival (DFS) using Kaplan-Meier estimates. Results: Ninety-three patients were included (male 46%; age 67 [interquartile range 60-76] years; pancreatic cancer 73%, metastatic 57%), resulting in 103 procedure combinations. Different combinations showed significantly different overall dysfunction rates (p = 0.009), ranging from the null rate of EUS-GE+HG to the 18% rate of EUS-GE+TPS, 31% of EUS-GE+EUS-CD, 53% of ES+TPS and 83% of ES+EUS-CDS. Sub-analyses restricted to biliary dysfunction confirmed these trends. A multivariate Cox proportional-hazards regression of DFS, a stenosis distal to the papilla (HR 3.2 [1.5-6.9]) and ES+EUS-CDS (HR 5.6 [2-15.7]) independently predicted dysfunction. Conclusions: Despite a lack of statistical power per combination, this study introduces new associations beyond the increased risk of GOO recurrence with ES versus EUS-GE. EUS-CDS showed reduced effectiveness and frequent dysfunction in the context of GOO, especially when combined with ES. EUS-GE+HGS or EUS-GE+TPS in this setting might result in superior patency. These results suggest that a prospective evaluation of the optimal endoscopic approach to malignant double obstruction is needed.

EUS-Guided Gastroenterostomy in Malignant Gastric Outlet Obstruction: A Comparative Study between First- and Second-Line Approaches after Enteral Stent Placement.

INTRODUCTION: Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is increasingly used in the setting of malignant gastric outlet obstruction (GOO). However, little is known about the role of primary EUS-GE. The aim of the present study is to compare the outcomes of EUS-GE by using the freehand technique as a first- and second-line approach after enteral stenting (ES). METHODS: This is an observational single-center study using a prospectively collected database. All consecutive patients who underwent an EUS-GE using the freehand technique due to malignant GOO were included. Patients with previous gastric surgery, a wire-guided EUS-GE technique, or those presenting without GOO were excluded. The primary outcome was the clinical success, defined as a solid oral intake at 1 week after the procedure (GOO Score, GOOSS ≥ 2). The secondary outcomes were technical success and adverse event (AE) rates. The impact on nutritional parameters was also assessed. RESULTS: Forty-five patients underwent an EUS-GE for all indications. Finally, 28 patients (mean age: 63 ± 17.2 years, 57.1% male) with (n = 13, 46.4%) and without (n = 15, 53.6%) a previous ES were included. The technical success was achieved in 25 cases (89.3%), with no differences between the two groups (92.3% vs. 86.7%, p = 1). The median limb diameter and procedure time were 27 mm (range:15-48) and 37 min. Overall, clinical success was achieved in 22 cases (88%), with three failures due to AEs (n = 2) or peritoneal carcinomatosis (n = 1). The diet progression was quicker in patients with a previous ES (GOOSS at 48 h, 2 vs. 1, p = 0.023), but the GOOSS at 1 week (p = 0.299), albumin gain (p = 0.366), and BMI gain (0.257) were comparable in the two groups. The AE rate was 7.1%. CONCLUSIONS: EUS-GE achieves a high technical and clinical success in patients with GOO regardless of the presence of a previous ES. Patients with previous ES may have a quicker progression of their diet, but the GOOSS and nutritional status in the long term at 1 week or 1 month are comparable. Primary EUS-GE might require fewer procedures and less discontinuation of chemotherapy to achieve a comparable result.

Endoscopic ultrasound-guided biliary drainage and gastrointestinal anastomoses: the journey from promising innovations to standard of care.

Biliary obstruction (BO) and gastric outlet obstruction (GOO) are frequent complications of pancreatobiliary and gastroduodenal neoplasia, which can severely impact oncological outcomes, patient survival and quality of life. Although endoscopic retrograde cholangiopancreatography (ERCP) remains the gold standard for biliary drainage, this may fail or be unfeasible because of duodenal/papillary infiltration or surgically-altered anatomy. Percutaneous transhepatic biliary drainage (PTBD) has been the standard rescue therapy in this setting, but is burdened by high morbidity and reduced quality of life. As for GOO, surgical gastroenterostomy and enteral stenting are limited by invasiveness and suboptimal long-term outcomes, respectively. Endoscopic ultrasound (EUS) has evolved from a diagnostic to a therapeutic modality, providing a safe and effective alternative for draining the pancreatobiliary tract into the stomach or duodenum. EUS-guided biliary drainage (EUS-BD) has already demonstrated similar efficacy, greater safety and fewer reinterventions compared to PTBD, and can be performed in the same session after ERCP failure. Further development of lumen apposing metal stents has paved the way towards the creation of EUS-guided anastomoses. EUS-guided gastroenterostomy (EUS-GE) is nowadays increasingly used to treat GOO, combining the minimal invasiveness of endoscopy with surgical-range efficacy. This review summarizes the technical details, current evidence and society recommendations contributing to EUS-BD and EUS-GE gaining ground in everyday practice or tertiary referral centers and becoming crucial in improving the multidisciplinary management of cancer-related symptoms.

Endoscopic ultrasound-guided drainage using lumen-apposing metal stent of malignant afferent limb syndrome in patients with previous Whipple surgery: Multicenter study (with video).

OBJECTIVES: Endoscopic ultrasound-guided digestive anastomosis (EUS-A) is a new alternative under evaluation in patients presenting with afferent limb syndrome (ALS) after Whipple surgery. The aim of the present study is to analyze the safety and effectiveness of EUS-A in ALS. METHODS: This is an observational multicenter study. All patients ≥18 years old with previous Whipple surgery presenting with ALS who underwent an EUS-A using a lumen-apposing metal stent (LAMS) between 2015 and 2021 were included. The primary outcome was clinical success, defined as resolution of the ALS or ALS-related cholangitis. Furthermore, technical success, adverse event rate, and mortality were evaluated. RESULTS: Forty-five patients (mean age: 65.5 ± 10.2 years; 44.4% male) were included. The most common underlying disease was pancreatic cancer (68.9%). EUS-A was performed at a median of 6 weeks after local tumor recurrence. The most common approach used was the direct/freehand technique (66.7%). Technical success was achieved in 95.6%, with no differences between large (≥15 mm) and small LAMS (97.4% vs. 100%, P = 0.664). Clinical success was retained in 91.1% of patients. A complementary treatment by dilation of the stent followed by endoscopic retrograde cholangiopancreatography through the LAMS was performed in three cases (6.7%). There were six recurrent episodes of cholangitis (14.6%) and two procedure-related adverse events (4.4%) after a median follow-up of 4 months. Twenty-six patients (57.8%) died during the follow-up due to disease progression. CONCLUSION: EUS-A is a safe and effective technique in the treatment of malignant ALS, achieving high clinical success with an acceptable recurrence rate.

Feasibility of therapeutic endoscopic ultrasound in the bridge-to-surgery scenario: The example of pancreatic adenocarcinoma.

Upfront resection is becoming a rarer indication for pancreatic ductal adenocarcinoma, as biologic behavior and natural history of the disease has boosted indications for neoadjuvant treatments. Jaundice, gastric outlet obstruction and acute cholecystitis can frequently complicate this window of opportunity, resulting in potentially deleterious chemotherapy discontinuation, whose resumption relies on effective, prompt and long-lasting management of these complications. Although therapeutic endoscopic ultrasound (t-EUS) can potentially offer some advantages over comparators, its use in potentially resectable patients is primal and has unfairly been restricted for fear of potential technical difficulties during subsequent surgery. This is a narrative review of available evidence regarding EUS-guided choledochoduodenostomy, gastrojejunostomy and gallbladder drainage in the bridge-to-surgery scenario. Proof-of-concept evidence suggests no influence of t-EUS procedures on outcomes of eventual subsequent surgery. Moreover, the very high efficacy-invasiveness ratio over comparators in managing pancreatic cancer-related symptoms or complications can provide a powerful weapon against chemotherapy discontinuation, potentially resulting in higher subsequent resectability. Available evidence is discussed in this short paper, together with technical notes that might be useful for endoscopists and surgeons operating in this scenario. No published evidence supports restricting t-EUS in potential surgical candidates, especially in the setting of pancreatic cancer patients undergoing neoadjuvant chemotherapy. Bridge-to-surgery t-EUS deserves further prospective evaluation.

Endoscopic ultrasound-guided gastroenterostomy versus duodenal stenting for malignant gastric outlet obstruction: an international, multicenter, propensity score-matched comparison.

BACKGROUND: Endoscopic duodenal stenting is the current standard treatment for malignant gastric outlet obstruction (GOO) in patients with limited life expectancy. However, duodenal stenting is prone to stent dysfunction. Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a novel technique with potentially superior stent patency. We compared clinical success, safety, and stent dysfunction of EUS-GE and duodenal stenting in patients with malignant GOO using propensity score matching. METHODS: This international, multicenter, retrospective study analyzed consecutive patients undergoing EUS-GE or duodenal stenting for GOO between 2015 and 2021 in three European centers. Primary outcomes were clinical success (GOO scoring system [GOOSS] ≥ 2) and stent dysfunction (GOOSS ≤ 1 after initial clinical success). A propensity score matching (1:1) analysis was performed using age, sex, underlying disease, disease stage, ascites, and peritoneal carcinomatosis as variables. RESULTS: 214 patients underwent EUS-GE (n = 107) or duodenal stenting (n = 107). After propensity score matching, 176 patients were matched and compared. Technical success rates for EUS-GE and duodenal stenting were 94 % (95 %CI 89 %-99 %) vs. 98 % (95 %CI 95 %-100 %), respectively (P = 0.44). Clinical success rates were 91 % (95 %CI 85 %-97 %) vs. 75 % (95 %CI 66 %-84 %; P = 0.008). Stent dysfunction occurred in 1 % (95 %CI 0-4 %) vs. 26 % (95 %CI 15 %-37 %) of patients (P < 0.001). Adverse event rate was 10 % (95 %CI 4 %-17 %) vs. 21 % (95 %CI 12 %-29 %; P = 0.09). CONCLUSION: EUS-GE had higher clinical success and lower stent dysfunction, with similar safety, compared with duodenal stenting, suggesting that EUS-GE may be preferred over duodenal stenting in patients with malignant GOO.

EUS-guided gallbladder drainage and subsequent peroral endoscopic cholecystolithotomy: A tool to reduce chemotherapy discontinuation in neoplastic patients?

Background and Aims: EUS-guided gallbladder drainage (EUS-GBD) is emerging as a valuable treatment for acute cholecystitis (AC) in patients unfit for surgery. When lumen-apposing metal stents are used, large-caliber access to the gallbladder allows for subsequent direct peroral endoscopic cholecystoscopy (POEC) and eventual cholecystolithotomy (CL), offering a potentially "curative" solution for frailer patients. The aim of this series was to evaluate the outcome of these procedures in oncologic patients experiencing AC, with a specific focus on chemotherapy continuity. Methods: A prospective registry of all consecutive therapeutic EUS procedures performed in the San Raffaele Institute between December 2020 and April 2021 was searched for EUS-GBD + POEC-CL performed in chemotherapy candidates. Clinical and technical variables were prospectively registered, as were days of chemotherapy delay and postprocedural outcomes. Results: Three consecutive patients with a diagnosis of a malignancy (2 pancreatic cancers and 1 severe myeloproliferative disease with skeletal lesions) experienced AC and were primarily treated by EUS-GBD. After 4 weeks, they were systematically scheduled for POEC-CL and lumen-apposing metal stent exchange for a double-pigtail plastic stent. All procedures and revisions were successful, with rapid clinical improvement. All gallbladders were cleared of food debris and stones between 3 and 15 mm using grasping forceps, polypectomy snares, Dormia baskets, and mechanical lithotripsy. One mild adverse event without any clinical consequence was registered during POEC-CL. Revisions did not interfere with the chemotherapy schedule. Technical variables (eg, gastric vs duodenal drainage or need for coaxial double-pigtail plastic stent) are discussed. Conclusions: EUS-GBD and subsequent POEC-CL allows a highly effective and minimally invasive solution for AC. These initial experiences promote further evaluation of this approach for all those individuals in whom surgical interventions are undesirable, such as oncologic patients whose prognosis depends on chemotherapy continuity, although further prospective confirmation in this setting should be pursued.

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review.

1: ESGE recommends a prolonged course of a prophylactic broad-spectrum antibiotic in patients with ascites who are undergoing therapeutic endoscopic ultrasound (EUS) procedures.Strong recommendation, low quality evidence. 2: ESGE recommends placement of partially or fully covered self-expandable metal stents during EUS-guided hepaticogastrostomy for biliary drainage in malignant disease.Strong recommendation, moderate quality evidence. 3: ESGE recommends EUS-guided pancreatic duct (PD) drainage should only be performed in high volume expert centers, owing to the complexity of this technique and the high risk of adverse events.Strong recommendation, low quality evidence. 4: ESGE recommends a stepwise approach to EUS-guided PD drainage in patients with favorable anatomy, starting with rendezvous-assisted endoscopic retrograde pancreatography (RV-ERP), followed by antegrade or transmural drainage only when RV-ERP fails or is not feasible.Strong recommendation, low quality evidence. 5: ESGE suggests performing transduodenal EUS-guided gallbladder drainage with a lumen-apposing metal stent (LAMS), rather than using the transgastric route, as this may reduce the risk of stent dysfunction.Weak recommendation, low quality evidence. 6: ESGE recommends using saline instillation for small-bowel distension during EUS-guided gastroenterostomy.Strong recommendation, low quality evidence. 7: ESGE recommends the use of saline instillation with a 19G needle and an electrocautery-enhanced LAMS for EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) procedures.Strong recommendation, low quality evidence. 8: ESGE recommends the use of either 15- or 20-mm LAMSs for EDGE, with a preference for 20-mm LAMSs when considering a same-session ERCP.Strong recommendation, low quality evidence.

EUS-guided hepaticogastrostomy for patients with afferent loop syndrome: a comparison with EUS-guided gastroenterostomy or percutaneous drainage.

OBJECTIVES: Where palliative surgery or percutaneous drainage used to be the only option in patients with afferent loop syndrome, endoscopic management by EUS-guided gastroenterostomy has been gaining ground. However, EUS-guided hepaticogastrostomy might also provide sufficient biliary drainage. Our aim was to evaluate the feasibility of EUS-guided hepaticogastrostomy for the management of afferent loop syndrome and provide comparative data on the different approaches. METHODS: The institutional databases were queried for all consecutive minimally invasive procedures for afferent loop syndrome. A retrospective, dual-centre analysis was performed, separately analysing EUS-guided hepaticogastrostomy, EUS-guided gastroenterostomy and percutaneous drainage. Efficacy, safety, need for re-intervention, hospital stay and overall survival were compared. RESULTS: In total, 17 patients were included (mean age 59 years (± SD 10.5), 23.5% female). Six patients, which were ineligible for EUS-guided gastroenterostomy, were treated with EUS-guided hepaticogastrostomy. EUS-guided gastroenterostomy and percutaneous drainage were performed in 6 and 5 patients respectively. Clinical success was achieved in all EUS-treated patients, versus 80% in the percutaneous drainage group (p = 0.455). Furthermore, higher rates of bilirubin decrease were seen among patients undergoing EUS: > 25% bilirubin decrease in 10 vs. 1 patient(s) in the percutaneously drained group (p = 0.028), with > 50% and > 75% decrease identified only in the EUS group. Using the ASGE lexicon for adverse event grading, adverse events occurred only in patients treated with percutaneous drainage (60%, p = 0.015). And last, the median number of re-interventions was significantly lower in patients undergoing EUS (0 (IQR 0.0-1.0) vs. 1 (0.5-2.5), p = 0.045) when compared to percutaneous drainage. CONCLUSIONS: In the management of afferent loop syndrome, EUS seems to outperform percutaneous drainage. Moreover, in our cohort, EUS-guided gastroenterostomy and hepaticogastrostomy provided similar outcomes, suggesting EUS-guided hepaticogastrostomy as the salvage procedure in situations where EUS-guided gastroenterostomy is not feasible or has failed.