Multiple endoscopic ultrasound (EUS) guided therapeutic interventions have been developed for the management of benign and malignant pancreaticobiliary and gastrointestinal luminal pathology. Recent high-quality evidence is increasingly validating these interventions and positioning them within evidence-based therapeutic algorithms.

Here we review therapeutic EUS-guided interventions including pancreatic fluid collection drainage, gastroenterostomy, biliary drainage, pancreatic duct drainage and gallbladder drainage. The most up-to-date high-quality evidence supporting these interventions is presented including comparative data with other conventional treatment options. Newer emerging interventions such as tumor ablation are also reviewed. Current controversies and future avenues for research are discussed. The key role of EUS-guided interventions in managing pancreaticobiliary pathology in patients with a surgically altered anatomy is highlighted.

Multiple EUS therapeutic interventions have evolved from experimental or rescue options to now well established first- and second-line interventions over other endoscopic, percutaneous and surgical alternatives with the support of high-quality data. Further research is needed to better optimize patient selection and guide long term postintervention follow-up.

We aimed to compare enteroscopy-assisted ERCP (EA-ERCP), laparoscopy-assisted ERCP (LA-ERCP), and endoscopic ultrasound-directed ERCP (EDGE) in terms of safety and efficacy in post-Roux-en-Y gastric bypass patients. We conducted a rigorous analysis based on a predefined protocol (PROSPERO, CRD42022368788). Sixty-seven studies were included. The technical success rates were 77% (CI 69-83%) for EA-ERCP, 93% (CI 91-96%) for LA-ERCP, and 96% (CI 92-98%) for EDGE. Subgroup differences were significant between the EA-ERCP and other groups (p < 0.05). The overall adverse event rates were 13% (CI 8-22%), 19% (CI 14-24%), and 20% (CI 12-31%), respectively (p = 0.49). Our findings suggest that EDGE and LA-ERCP may be more effective and as safe as EA-ERCP.

The study aimed to develop international consensus recommendations on the safe use of lumen-apposing metal stents (LAMSs) for on- and off-label indications.

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.

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.

Through a modified international Delphi process, we developed general and indication-specific experience- and evidence-based recommendations on the safe use of LAMS.

Video 1Natural orifice transendoscopic surgery as a rescue for a dislodged lumen-apposing metal stent after EUS-directed transgastric ERCP.

In patients with Roux-en-Y gastric bypass (RYGB) anatomy, laparoscopic endoscopic retrograde cholangiopancreatography (LA-ERCP) and enteroscopy-assisted ERCP (E-ERCP) have been utilized to achieve pancreaticobiliary access. Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) has recently emerged as an alternate and efficient approach. As data regarding EDGE continues to evolve, concerns about safety and efficacy remain, limiting wide adoptability. We performed a systematic review and meta-analysis to assess the safety and efficacy of EDGE and compare it to the current standard of care.

A comprehensive search of major databases (inception to Nov 2022) identified published studies on EDGE. A random-effects model was used to calculate the pooled rates and heterogeneity (I2). Risk ratio (RR) and standardized difference in means (SMD) were utilized for head-to-head comparison analysis between EDGE vs. LA-ERCP and EDGE vs. E-ERCP. Primary outcomes assessed pooled EDGE safety (adverse events) and efficacy (technical/clinical success). Secondary outcomes assessed efficacy and safety profiles via a comparative analysis of EDGE vs. LA-ERCP and EDGE vs. E-ERCP.

A total of 16 studies (470 patients) were included. EDGE pooled technical success (TS) rate was 96% (95% CI 92-97.6, I2 = 0), and clinical success was 91% (85-95, I2 = 0). Pooled rate of all adverse events with EDGE was 17% (14-24.6, I2 = 32%). On sub-group analysis, these included failure of fistula closure 17% (10-25.5, I2 = 48%), stent migration 7% (4-12, I2 = 51%), bleeding 5% (3.2-7.9, I2 = 0), post-EDGE weight gain 4% (2-9, I2 = 0), perforation 4% (2.1-5.8, I2 = 0), and post-ERCP pancreatitis 2% (1-5, I2 = 0). EDGE TS was comparable to LA-ERCP (97% vs. 98%; RR, 1.00; CI, 0.85-1.17, p = 0.95) and E-ERCP (100% vs. 66%; RR, 1.26; CI, 0.99-1.6, p = 0.06). No statistical difference was noted in adverse events between EDGE and LA-ERCP (13% vs. 17.6%; RR, 0.61; CI, 0.28-1.35, p = 0.52) and E-ERCP (9.6% vs. 16%; RR, 0.61; CI, 0.28-1.35, p = 0.22). EDGE procedure time and hospital stay were shorter than LA-ERCP and E-ERCP (p < 0.001).

Our analysis shows that EDGE is safe and efficacious to the current standard of care. Further head-to-head comparative trials are needed to validate our findings.

EUS-directed transgastric intervention (EDGI) is an established technique for the management of pancreaticobiliary pathology in Roux-en-Y gastric bypass (RYGB) patients. There is an inherent risk of intraprocedural stent dislodgement, leading to perforation. The procedure is therefore often performed in 2 stages, 2 to 4 weeks apart, to allow for fistula maturation to mitigate the risk of lumen-apposing metal stent (LAMS) dislodgment. However, some clinical indications such as cholangitis require more urgent intervention, rendering this approach impractical. The aim of this study was to evaluate the safety and efficacy of same-session (SS)-EDGI with fixation of a 20-mm LAMS using endoscopic suturing.

This was a 2-center, retrospective study of consecutive RYGB patients who underwent SS-EDGI using a sutured 20-mm LAMS between February 2018 and May 2020. Patient demographics, procedural details, and clinical outcomes were recorded.

Thirty-seven patients (mean age, 58.1 years; 86.5% women) underwent SS-EDGI with a median follow-up of 31.8 months. The procedural intervention was ERCP in 33 patients (89.2%) and ERCP with EUS in 4 patients (10.8%). Technical success was 100%. Access was achieved through the gastrogastric fistula in 26 patients (70.3%) and the jejunogastric fistula in 11 (29.7%). The LAMS was anchored with 2 endoscopic sutures in 33 patients (89.2%) and 1 suture in 4 (10.8%). Adverse events occurred in 4 patients (10.8%; 3 postprocedural bleeding, 1 cholangitis). There were no episodes of stent dislodgement or delayed stent migration. A persistent fistula was diagnosed in 7 patients (18.9%) who underwent objective testing (n = 28, 75.7%), of which 6 were successfully closed endoscopically.

Single-stage EDGI using a sutured 20-mm LAMS was associated with a high rate of technical success, low rates of adverse events, and no episodes of stent migration. Persistent fistulas, although common, were amenable to endoscopic management.

Although released only for drainage of pseudocyst and walled-off necrosis (WON) with ≤ 30% solid debris, the utilization of lumen-apposing metal stent (LAMS) in "real-world" practice has deviated from approved indications. We evaluated the contemporary use of LAMS and associated clinical, procedural outcomes in the setting of a tertiary referral center in the USA.

Data from 303 consecutive patients who underwent LAMS placement were analyzed. Outcomes included technical and clinical success rates and adverse events.

Of 303 patients, 190 (62.7%) received LAMS for off-label indications. The latter included gallbladder drainage (n = 56, 18.5%), gastroenterostomy (n = 52, 17.2%), treatment of gastrointestinal strictures (n = 37, 12.2%), biliary drainage (n = 20, 6.6%), temporary gastric access for endoscopy (n = 13, 4.3%), symptomatic WON with > 30% solid debris (n = 8, 2.6%), and miscellaneous (n = 4, 1.3%). Technical success rates in the on- and off-label arm were 98.2% and 95.8%, respectively (P = .331; 95% CI 0.08 to 1.96). Clinical success rates in the on- and off-label arm were 89.4% and 83.2%, respectively (P = .137; 95% CI 0.28 to 1.19). The rate of adverse events was 20.5% (n = 39) in the off-label arm and 16.8% (n = 19) in the on-label arm (P = .242; 95% CI 0.69 to 2.34).

Off-label use of LAMS out-numbered on-label use in our practice. The safety profile between the groups was similar and with the exception of refractory stricture treatment, efficacy was comparable.

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.

Endoscopic stenting is a well-established option for the treatment of malignant obstruction, temporary management of benign strictures, and sealing transmural defects, as well as drainage of pancreatic fluid collections and biliary obstruction. In recent years, in addition to expansion in indications for endoscopic stenting, considerable strides have been made in stent technology, and several types of devices with advanced designs and materials are continuously being developed. In this review, we discuss the important developments in stent designs and novel indications for endoluminal and transluminal stenting. Our discussion specifically focuses on (i) biodegradable as well as (ii) irradiating and drug-eluting stents for esophageal, gastroduodenal, biliary, and colonic indications, (iii) endoscopic stenting in inflammatory bowel disease, and (iv) lumen-apposing metal stent.

BACKGROUND : Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) has emerged as a viable completely endoscopic method for performing pancreaticobiliary interventions in patients with Roux-en-Y gastric bypass anatomy. The aims of this systematic review were: (1) to describe the indications, outcomes, and complications of EDGE; and (2) to identify deficiencies in our knowledge of important technical approaches and clinical outcomes. METHODS : A systematic review was conducted via comprehensive searches of Medline, Scopus, CINAHL, and Cochrane to identify studies focusing on EDGE outcomes. Simple descriptive statistics were derived from case series only. Case reports were only included to qualitatively describe additional indications, techniques, and adverse events. RESULTS : The initial search identified 2143 abstracts. Nine case series and eight case reports were included. In the nine case series, 169 patients underwent EDGE. The technical success rate was 99 % (168 /169) for gastrogastrostomy/jejunogastrostomy creation and 98 % (166 /169) for subsequent ERCP. Minor adverse events specifically related to EDGE occurred in 18 % (31/169) and included intraprocedural stent migration/malposition (n = 27) and abdominal pain (n = 4). Moderate adverse events specific to EDGE occurred in 5 % (9/169): including bleeding (2 %), persistent fistula (1 %), and perforation (1 %). Severe adverse events occurred in one patient with a perforation requiring surgery. Deficiency in reporting on the clinical significance of adverse events was identified. CONCLUSION : Based on limited observational data, in expert hands, EDGE has a high rate of technical success and an acceptable rate of adverse events. As a novel procedure, many knowledge gaps need to be addressed to inform the design of meaningful comparative studies and guide informed consent.

EUS-directed transgastric ERCP (the EDGE procedure) is a simplified method of performing ERCP in Roux-en-Y gastric bypass patients. The EDGE procedure involves placement of a lumen-apposing metal stent (LAMS) into the excluded stomach to serve as a conduit for passage of the duodenoscope for pancreatobiliary intervention. Originally a multistep process, urgent indications for ERCP have led to the development of single-session EDGE (SS-EDGE) with LAMS placement and ERCP performed in the same session. The goal of this study was to identify predictive factors of intraprocedural LAMS migration in SS-EDGE.

We conducted a multicenter retrospective review that included 9 tertiary medical centers across the United States. Data were collected and analyzed from 128 SS-EDGE procedures. The primary outcome was intraprocedural LAMS migration. Secondary outcomes were other procedural adverse events such as bleeding and perforation.

Eleven LAMS migrations were observed in 128 procedures (8.6%). Univariate analysis of clinically relevant variables was performed, as was a binary logistic regression analysis of stent diameter and stent dilation. This revealed that use of a smaller (15 mm) diameter LAMS was an independent predictor of intraprocedural stent migration (odds ratio, 5.36; 95% confidence interval, 1.29-22.24; P = .021). Adverse events included 3 patients who required surgery and 2 who experienced intraprocedural bleeding.

Use of a larger-diameter LAMS is a predictive factor for a nonmigrated stent and improved procedural success in SS-EDGE. Although larger patient cohorts are needed to adequately assess these findings, performance of LAMS dilation and fixation may also decrease risk of intraprocedural LAMS migration and improve procedural success.

Lumen-apposing metal stents (LAMSs) are a novel class of devices that have expanded the spectrum of endoscopic GI interventions. LAMSs with their dumbbell configuration, short saddle length, and large inner luminal diameter provide favorable stent characteristics to facilitate anastomosis formation between the gut lumen and adjacent structures.

The MEDLINE database was searched through April 2021 for articles related to LAMSs by using additional relevant keywords such as "walled-off pancreatic necrosis," "pseudocysts," "pancreatic fluid collection," "cholecystitis," "gastroenterostomy," in addition to "endoscopic treatment" and "endoscopic management," among others.

This technology review describes the full spectrum of LAMS designs and delivery systems, techniques for deployment, procedural outcomes, safety, training issues, and financial considerations.

Although LAMSs were initially introduced for drainage of pancreatic pseudocysts and walled-off necrosis, the versatility of these devices has led to a variety of off-label uses including gallbladder drainage, enteric bypass with the creation of gastroenterostomies, and treatment of luminal GI strictures.

EUS-directed transgastric ERCP (EDGE) is an endoscopic modality for treating pancreaticobiliary disorders after Roux-en-Y gastric bypass. EDGE consists of EUS-directed gastrogastrostomy/jejunogastrostomy creation (EUS-GG; step 1), followed by transgastric ERCP (step 2). The two steps can be performed in the same or separate endoscopic session(s). Single-session EDGE is immediately therapeutic but risks perforation via LAMS dislodgement. Dual-session EDGE does not risk perforation, but the clinical malady festers during the 10-14-day interval required for fistula maturation. A "shortened-interval dual-session" EDGE (2-4 day interval) may resolve this dilemma. Our study compares 20-mm LAMS dislodgement risk between single-session and shortened-interval dual-session EDGE.

We conducted a single-center retrospective study of 21 RYGB patients who underwent EDGE using 20-mm LAMS by one advanced endoscopist between 3/2018 and 2/2020. Given the small sample size, a permutation of regressor residuals test was conducted to investigate the association between EDGE interval type and LAMS dislodgement, controlling for the effect of fistula type.

Eleven patients (six female; mean age 55 years old) underwent single-session EDGE; LAMS dislodgement occurred in five cases (45%). Ten patients (eight female; mean age 60 years old) underwent shortened-interval dual-session EDGE (median interval 2 days); LAMS dislodgement occurred in one case (10%). The odds of LAMS dislodgement during single-session EDGE was 817% that of shortened-interval dual-session EDGE (OR 8.17; p = 0.05), after controlling for the effect of fistula type.

Shortened-interval dual-session EDGE decreases the risk of intraprocedural 20-mm LAMS dislodgement while allowing for timely transgastric ERCP.

Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. The aims of this study were: (1) to determine the rates of long-term adverse events after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; (2) to identify predictors of persistent fistula; (3) to assess the outcomes of endoscopic closure when persistent fistula is encountered.

This was a multicenter retrospective study involving 13 centers between February 2015 and March 2019. Adverse events were defined according to the ASGE lexicon. Persistent fistula was defined as an upper gastrointestinal series or esophagogastroduodenoscopy showing evidence of fistula.

178 patients (mean age 58 years, 79 % women) underwent EDGE. Technical success was achieved in 98 % of cases (175/178), with a mean procedure time of 92 minutes. Periprocedural adverse events occurred in 28 patients (15.7 %; mild 10.1 %, moderate 3.4 %, severe 2.2 %). The four severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10 % of those sent for objective testing (9/90). Following identification of a fistula, 5 /9 patients underwent endoscopic closure procedures, which were successful in all cases.

The EDGE procedure is associated with high clinical success rates and an acceptable risk profile. Persistent fistulas after lumen-apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistulas are identified, endoscopic treatment is warranted, and should be successful in closing the fistula.

Access to the Common Bile Duct in patients with surgically altered UGI anatomy such as RYGB is exceptionally challenging. Previously, these patients could only be treated by open surgery; however, multiple new advanced assisted ERCP techniques such as EDGE, LA-ERCP, and DEA-ERCP have now been developed and indeed successfully used to treat these patients. Despite growing experience, these techniques have yet to become part of our mainstream practice and many clinicians remain unfamiliar or even unaware of them; as a result, they are unfortunately often overlooked. We conducted this systematic review to try and shed more light on them and understand which of these techniques resulted in the best patient outcomes. We conducted a systematic review of PubMed database publications between December 2008 and December 2018. Keyword variants of "EDGE, Enteroscopy-assisted & laparoscopy-assisted ERCP" and "altered surgical anatomy" were combined to identify relevant papers for inclusion. We identified 34 studies, comprising a total of 1848 advanced assisted ERCPs in patients with altered UGI anatomy from 12 different countries. These papers were critically appraised, summarised, and presented in table format. EDGE and LA-ERCP were associated with both the highest overall combined CBD cannulation rates (99.3% for both vs 74.6% for DEA-ERCP) and ERCP interventional success (98.3% for EDGE vs 97.4% for LA-ERCP and 67.6% for DEA-ERCP). Advanced ERCP is associated with excellent success rates and a higher safety profile than surgery; however, patient selection and identification of the exact surgical anatomy are key.

Background and study aims  Endoscopic ultrasound-directed transgastric ERCP (EDGE) is a new endoscopic procedure to perform ERCP in Roux-en-y gastric bypass (RYGB) patients. The aim of this study was to conduct a systematic review and meta-analysis to evaluate technical success, clinical success and adverse effects of EDGE and compare it to laparoscopic ERCP (LA-ERCP) and balloon ERCP (BE-ERCP). Patients and methods  We conducted a comprehensive search of several databases and conference proceedings including PubMed, EMBASE, Google-Scholar, LILACS, SCOPUS, and Web of Science databases to identify studies reporting on EDGE, LA-ERCP, and BE-ERCP. The primary outcome was to evaluate technical and clinical success of all three procedures and the secondary analysis focused on calculating the pooled rate of all adverse events (AEs), along with the commonly reported AE subtypes. Results  Twenty-four studies on 1268 patients were included in our analysis with the majority of the population being males with mean age 53.72 years. Pooled rates of technical and clinical success with EDGE wer 95.5 % and 95.9 %, with LA-ERCP were 95.3 % and 92.9 % and were BE-ERCP were 71.4 % and 58.7 %, respectively. Pooled rates of all AEs with EDGE were 21.9 %, with LA-ERCP 17.4 % and with BE-ERCP 8.4 %. Stent migration was the most common AE with EDGE with 13.3 % followed by bleeding with 6.6 %. Conclusion  Our meta-analysis demonstrated that the technical and clinical success of EDGE procedure is better than BE-ERCP and comparable to that of LA-ERCP in RYGB patients. EDGE also has a similar safety profile as compared to LA-ERCP but has higher AE rate as compared to BE-ERCP.