Manuel Perez-Miranda

Initial experience with EUS-guided cholangiopancreatography for biliary and pancreatic duct drainage: a Spanish national survey.

BACKGROUND EUS-guided cholangiopancreatography (ESCP) allows transmural access to biliopancreatic ducts when ERCP fails. Data regarding technical details, safety, and outcomes of ESCP are still unknown. OBJECTIVE To evaluate outcomes of ESCP in community and referral centers at the initial development phase of this procedure, to identify the ESCP stages with higher risk of failure, and to evaluate the influence on outcomes of factors related to the endoscopist. DESIGN Multicenter retrospective study. SETTING Public health system hospitals with experience in ESCP in Spain. PATIENTS A total of 125 patients underwent ESCP in 19 hospitals, with an experience of <20 procedures. INTERVENTION ESCP. MAIN OUTCOME MEASUREMENTS Technical success and complication rates in the initial phase of implantation of ESCP are described. The influence of technical characteristics and endoscopist features on outcomes was analyzed. RESULTS A total of 125 patients from 19 hospitals were included. Biliary ESCP was performed in 106 patients and pancreatic ESCP was performed in 19. Technical success was achieved in 84 patients (67.2%) followed by clinical success in 79 (63.2%). Complications occurred in 29 patients (23.2%). Unsuccessful manipulation of the guidewire was responsible for 68.2% of technical failures, and 58.6% of complications were related to problems with the transmural fistula. LIMITATIONS Retrospective study. CONCLUSION Outcomes of ESCP during its implantation stage reached a technical success rate of 67.2%, with a complication rate of 23.2%. Intraductal manipulation of the guidewire seems to be the most difficult stage of the procedure.

Endoscopic Ultrasound-assisted Bile Duct Access and Drainage Multicenter, Long-term Analysis of Approach, Outcomes, and Complications of a Technique in Evolution

Background and Study Aims: When endoscopic retrograde cholangio-pancreatography fails, the bile duct is drained percutaneously or surgically. Evolution of endoscopic ultrasound (EUS) has provided the ability to visualize and also drain the biliary tree. The aim of this study was to review different techniques of EUS-guided bile duct access and drainage, and compare extrahepatic (EH) and intrahepatic (IH) approaches and benign with malignant indications. Patients and Methods: EUS-guided attempts at bile duct drainage from 6 international centers were reviewed. This is a multicenter, nonrandomized retrospective study. Results: Two hundred forty patients underwent EUS-guided bile duct access and drainage (EUS-BD) with a mean age of 67.3 years. The IH approach was used in 60% of the cases. In 99% of the subjects, a 19-G needle was used. Success was achieved in 87% cases, with a similar success rate in EH and IH approaches (84.3% vs. 90.4%; P=0.15). Metal stents were placed in 60% and plastic stents in 27% of the cases. A higher success rate was noted in malignant diseases compared with benign diseases (90.2% vs. 77.3%; P=0.02). Complications for all techniques included pneumoperitoneum 5%, bleeding 11%, bile leak/peritonitis 10%, and cholangitis 5%. No significant difference was noted between the IH and the EH approaches (32.6% vs. 35.6%; P=0.64), with similar rates in benign and malignant diseases (26.7% vs. 37.1%; P=0.19). Conclusions: The EUS-BD technique is currently limited by a lack of dedicated devices and large data reporting outcomes and complications. Larger prospective and multicenter studies are needed to better define the indications, outcomes, and complications. With greater experience and dedicated devices, EUS-BD can be an effective alternative.

EUS-guided transenteric gallbladder drainage with a new fistula-forming, lumen-apposing metal stent

e g ( u s p s t l a m w W t g t Laparoscopic cholecystectomy is the standard approach for patients with lithiasic acute cholecystitis. However, some are patients unsuitable for cholecystectomy because of advanced age, underlying comorbidities, or malignances: in these cases, percutaneous transhepatic gallbladder drainage is the treatment of choice up to now,3,4 with linical success rates between 56% and 100%.5,6 Nevertheless, the percutaneous approach has many drawbacks including pneumothorax, biliary peritonitis, or bleeding, reported in up to 12% of cases,5 and potential complicaions secondary to premature tube removal or dislodgeent in 0.3% to 12% of patients.7-11 Furthermore, high ates of recurrence of cholecystitis (33%) have been reorted after removal of the drainage catheter.8 The procedure is also uncomfortable for the patient, and ongoing nurse maintenance is required. Endoscopic methods for gallbladder drainage include the transpapillary approach (with plastic stents12,13 or naso-gallbladder drainage NGBD]14,15) or EUS-guided transmural gallbladder drainage. To date, there are scant data about safety and feasibility of EUS-guided transmural gallbladder drainage.16-20 In contrast, EUS-guided transenteric drainage of peripancreatic collections by using tubular stents (plastic or selfexpandable metal stents [SEMS]) has become a strengthened therapeutic procedure, replacing percutaneous or surgical drainages. However, tubular-shaped stents (plastic or metal) have disadvantages and risks, such as bile leakage or migration. Furthermore, the slow flow of bile and the small caliber of plastic stents can result in early malfunction and clogging. These inconveniences could be avoided with the recently developed self-expandable lumen-apposing metal stent AXIOS (Xlumena Inc, Moun-

EUS-guided gall bladder drainage with a lumen-apposing metal stent: a prospective long-term evaluation

Endoscopic ultrasound-guided gall bladder drainage (EUS-GBD) has been shown to be comparable with percutaneous gall bladder drainage (PTGBD) in terms of technical feasibility and clinical efficacy for the treatment of acute cholecystitis in high-risk surgical patients.1 However, a potential serious complication of this technique is air or bile leakage into the peritoneal cavity, since insertion of a drain or plastic stent requires a fistula tract with a diameter larger than the diameter of the inserted drain or stent. Therefore, a specifically designed lumen-apposing metal stents (LAMSs) has been developed for transenteric drainage and successfully tested in animal models.2 ,3 Preliminary clinical experience with LAMSs for drainage of peri-pancreatic fluid collections (PFCs) appears to be consistent with anchoring features tested in animal models.4–6 However, reports on the use of LAMSs for gall bladder drainage are limited to case reports and small case series without long-term follow-up.3 ,5 ,7–12 We performed a multicentre, prospective study to determine the feasibility and safety of the use of LAMS for EUS-GBD in high-risk surgical patients with acute cholecystitis. A total of 30 patients were included. Technical success was achieved in 27 of 30 patients (90%) (figure 1) and clinical success in 26 of 27 patients (96%). Two of 27 patients (7%) developed recurrent cholecystitis due to LAMS obstruction. Successful LAMS removal was performed in 15 of 30 patients (50%) after a mean of 91 days (SD±24 days). In 15 patients (50%), no LAMS removal was performed because of death (n=5), significant tissue overgrowth (n=2) or other causes (n=8). Mean follow-up was 298 days (SD±82 days) for all patients and 364 days (SD±82 days) for the patients alive at the end of the study. A total of 15 serious adverse events (SAEs) (50%) were …

Endoscopic ultrasonography guided biliary drainage: Summary of consortium meeting, May 7th, 2011, Chicago

Endoscopic retrograde cholangiopancreatography (ERCP) has become the preferred procedure for biliary or pancreatic drainage in various pancreatico-biliary disorders. With a success rate of more than 90%, ERCP may not achieve biliary or pancreatic drainage in cases with altered anatomy or with tumors obstructing access to the duodenum. In the past those failures were typically managed exclusively by percutaneous approaches by interventional radiologists or surgical intervention. The morbidity associated was significant especially in those patients with advanced malignancy, seeking minimally invasive interventions and improved quality of life. With the advent of biliary drainage via endoscopic ultrasound (EUS) guidance, EUS guided biliary drainage has been used more frequently within the last decade in different countries. As with any novel advanced endoscopic procedure that encompasses various approaches, advanced endoscopists all over the world have innovated and adopted diverse EUS guided biliary and pancreatic drainage techniques. This diversity has resulted in variations and improvements in EUS Guided biliary and pancreatic drainage; and over the years has led to an extensive nomenclature. The diversity of techniques, nomenclature and recent progress in our intrumentation has led to a dedicated meeting on May 7(th), 2011 during Digestive Disease Week 2011. More than 40 advanced endoscopists from United States, Brazil, Mexico, Venezuela, Colombia, Italy, France, Austria, Germany, Spain, Japan, China, South Korea and India attended this pivotal meeting. The meeting covered improved EUS guided biliary access and drainage procedures, terminology, nomenclature, training and credentialing; as well as emerging devices for EUS guided biliary drainage. This paper summarizes the meetings agenda and the conclusions generated by the creation of this consortium group.

Covered Metal Stents for the Treatment of Biliary Complications after Orthotopic Liver Transplantation

BACKGROUND Biliary complications, a major source of morbidity after orthotopic liver transplantation (OLT), are increasingly being treated by endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic management has been shown to be superior to percutaneous therapy and surgery. Covered self-expandable metal stents (CSEMSs) may be an alternative to the current endoscopic standard treatment with periodic plastic stent replacement. OBJECTIVE To assess the safety and efficacy of temporary CSEMS insertion for biliary complications after OLT. METHODS From November 2001 to December 2009, the 242 OLT performed in 226 patients included 67 cases that developed post-OLT leaks or strictures (29.6%), excluding ischemic biliary complications. CSEMSs were used in 22 patients (33%), 18 male and 4 female, with an overall median age of 55 years (range, 29-69). In-house OLT patients underwent an index ERCP at 26 days (range, 8-784) after OLT. Their records were reviewed to determine ERCP findings, technical success, and clinical outcomes. RESULTS ERCP with sphincterotomy was performed in all 22 patients, revealing 18 with biliary strictures alone (82%), 3 with strictures and leaks (14%), and 1 with strictures and choledocholithiasis (4%). All strictures were anastomotic. All patients had 1-2 plastic stents inserted across the anastomosis (11 had prior balloon dilation); stones were successfully removed, for an initial technical success rate of 100% (22/22). CSEMSs, were placed at the second ERCP in 14 patients, at the third in 7, and at the fourth in 1. With a median follow-up of 12.5 months (range, 3-25) after CSEMS removal, 21/22 patients (95.5%) remain stricture free and one relapsed, requiring repeat CSEMS insertion. Four patients experienced pain after CSEMS insertion. At CSEMS removal, migration was noted in 5 cases, into either the distal duodenum (n=4) or the proximal biliary tree (n=1), and embedding was seen in 1 case. There were no serious complications; no patients needed hepatojejunostomy. CONCLUSIONS ERCP is a safe first-line approach for post-OLT biliary complications. It was highly successful in a population with anastomotic leaks and strictures. The therapeutic role of ERCP to manage biliary complications after OLT in the long term is not well known. In our experience, the high rate (close to 95%) of efficacy and its relative safety allowed us to use CSEMS to manage refractory biliary post-OLT strictures. CSEMS insertion may preclude most post-OLT hepatojejunostomies.

Endosonography-guided cholangiopancreatography as a salvage drainage procedure for obstructed biliary and pancreatic ducts

Endoscopic ultrasound allows transmural access to the bile or pancreatic ducts and subsequent contrast injection to provide ductal drainage under fluoroscopy using endoscopic retrograde cholangiopancreatography (ERCP)-based techniques. Differing patient specifics and operator techniques result in six possible variant approaches to this procedure, known as endosonography-guided cholangiopancreatography (ESCP). ESCP has been in clinical use for a decade now, with over 300 cases reported. It has become established as a salvage procedure after failed ERCP in the palliation of malignant biliary obstruction. Its role in the management of clinically severe chronic/relapsing pancreatitis remains under scrutiny. This review aims to clarify the concepts underlying the use of ESCP and to provide technical tips and a detailed step-by-step procedural description.

Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience.

Background: Surgical gastrojejunostomy and enteral self-expanding metal stents are efficacious for the management of gastric outlet obstruction but limited by high complication rates and short-term efficacy. Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is a novel alternative option. Patients and methods: Patients who underwent EUS-GJ between March 2014 and September 2015 as part of a prospective multicenter registry at four academic centers in two countries were included. Technical success was defined as successful placement of a gastrojejunal lumen-apposing metal stent. Clinical success was defined as the ability of the patient to tolerate an oral diet. Post-procedural adverse events were recorded. Results: The study included 26 patients, of whom 11 (42 %) were male. Technical success was achieved in 24 patients (92 %). Clinical success was achieved in 22 patients (85 %). Of the 4 patients in whom clinical success was not achieved, 2 had persistent nausea and vomiting despite a patent EUS-GJ and required enteral feeding for nutrition, 1 died before the initiation of an oral diet, and 1 underwent surgery for suspected perforation. Adverse events, including peritonitis, bleeding, and surgery, occurred in 3 patients (11.5 %). Conclusion: EUS-GJ is an emerging procedure that has efficacy and safety comparable with those of current therapies and should hold a place as a new minimally invasive option for patients with gastric outlet obstruction. Clinical trial identification number: NCT01522573

Evaluation of the short- and long-term effectiveness and safety of fully covered self-expandable metal stents for drainage of pancreatic fluid collections: results of a Spanish nationwide registry

BACKGROUND AND AIMS Initial reports suggest that fully covered self-expandable metal stents (FCSEMSs) may be better suited for drainage of dense pancreatic fluid collections (PFCs), such as walled-off pancreatic necrosis. The primary aim was to analyze the effectiveness and safety of FCSEMSs for drainage of different types of PFCs in a large cohort. The secondary aim was to investigate which type of FCSEMS is superior. METHODS This was a retrospective, noncomparative review of a nationwide database involving all hospitals in Spain performing EUS-guided PFC drainage. From April 2008 to August 2013, all patients undergoing PFC drainage with an FCSEMS were included in a database. The main outcome measurements were technical success, short-term (2 weeks) and long-term (6 months) effectiveness, adverse events, and need for surgery. RESULTS The study included 211 patients (pseudocyst/walled-off pancreatic necrosis, 53%/47%). The FCSEMSs used were straight biliary (66%) or lumen-apposing (34%). Technical success was achieved in 97% of patients (95% confidence interval [CI], 93%-99%). Short-term- and long-term clinical success was obtained in 94% (95% CI, 89%-97%) and 85% (95% CI, 79%-89%) of patients, respectively. Adverse events occurred in 21% of patients (95% CI, 16%-27%): infection (11%), bleeding (7%), and stent migration and/or perforation (3%). By multivariate analysis, patient age (>58 years) and previous failed drainage were the most important factors associated with negative outcome. CONCLUSIONS An FCSEMS is effective and safe for PFC drainage. Older patients with a history of unsuccessful drainage are more likely to fail EUS-guided drainage. The type of FCSEMS does not seem to influence patient outcome.

Endoscopic ultrasound-guided gallbladder drainage for the management of acute cholecystitis (with video)

Endoscopic ultrasound‐guided gallbladder drainage (EUS‐GBD) has been introduced as an alternative to percutaneous transhepatic gallbladder drainage for the treatment of acute cholecystitis in non‐surgical candidates. A systematic review of the English language literature through PubMed search until June 2014 was conducted. One hundred and fifty‐five patients with acute cholecystitis treated with EUS‐GBD in eight studies and 12 case reports, and two patients with EUS‐GBD for other causes were identified. Overall, technical success was obtained in 153 patients (97.45%) and clinical success in 150 (99.34%) patients with acute cholecystitis. Adverse events developed in less than 8% of patients, all of them managed conservatively. EUS‐GBD has been performed with plastic stents, nasobiliary drainage tubes, standard or modified tubular self‐expandable metal stents (SEMS) and lumen‐apposing metal stents (LAMS) by different authors with apparently similar outcomes. No comparison studies between stent types for EUS‐GBD have been reported. EUS‐GBD is a promising novel alternative intervention for the treatment of acute cholecystitis in high surgical risk patients. Feasibility, safety and efficacy in published studies from expert centers are very high compared to currently available alternatives. Further studies are needed to establish the safety and long‐term outcomes of this procedure in other practice settings before EUS‐GBD can be widely disseminated.