Development of devices for interventional endoscopic ultrasound for the management of pancreatobiliary diseases.

A variety of devices have been developed for interventional endoscopic ultrasound (EUS). EUS-guided drainage of the bile duct and pancreatic duct, as well as fluid collection adjacent to the gastrointestinal tract, is performed by a procedure involving puncture, guidewire manipulation, tract dilation, and stent placement. Devices specialized for interventional EUS are being developed for each step of the procedure. Mechanical dilators such as bougie, balloon, and electrocautery dilators are used for tract dilation. Various types of plastic stents, self-expandable metal stents, and lumen-apposing metal stents specifically designed for interventional EUS are now available, including one-step devices developed to improve the efficacy and safety of interventional EUS. In addition, radiofrequency ablation and the placement of fiducial markers and radioactive seeds under EUS guidance are now becoming established for pancreatic neoplasms. Such development of specialized devices has expanded the indications for interventional EUS, increased the success rate, and lowered the adverse event rate.

Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1).

OBJECTIVE: The optimal management of acute cholecystitis in patients at very high risk for cholecystectomy is uncertain. The aim of the current study was to compare endoscopic ultrasound (EUS)-guided gallbladder drainage (EUS-GBD) to percutaneous cholecystostomy (PT-GBD) as a definitive treatment in these patients under a randomised controlled trial. DESIGN: Consecutive patients suffering from acute calculous cholecystitis but were at very high-risk for cholecystectomy were recruited. The primary outcome was the 1-year adverse events rate. Secondary outcomes include technical and clinical success, 30-day adverse events, pain scores, unplanned readmissions, re-interventions and mortalities. RESULTS: Between August 2014 to February 2018, 80 patients were recruited. EUS-GBD significantly reduced 1 year adverse events (10 (25.6%) vs 31 (77.5%), p<0.001), 30-day adverse events (5 (12.8%) vs 19 (47.5%), p=0.010), re-interventions after 30 days (1/39 (2.6%) vs 12/40 (30%), p=0.001), number of unplanned readmissions (6/39 (15.4%) vs 20/40 (50%), p=0.002) and recurrent cholecystitis (1/39 (2.6%) vs 8/40 (20%), p=0.029). Postprocedural pain scores and analgesic requirements were also less (p=0.034). The technical success (97.4% vs 100%, p=0.494), clinical success (92.3% vs 92.5%, p=1) and 30-day mortality (7.7% vs 10%, p=1) were statistically similar. The predictor to recurrent acute cholecystitis was the performance of PT-GBD (OR (95% CI)=5.63 (1.20-53.90), p=0.027). CONCLUSION: EUS-GBD improved outcomes as compared to PT-GBD in those patients that not candidates for cholecystectomy. EUS-GBD should be the procedure of choice provided that the expertise is available after a multi-disciplinary meeting. Further studies are required to determine the long-term efficacy. TRIAL REGISTRATION NUMBER: NCT02212717.

Recent advances in endoscopic ultrasound-guided biliary drainage.

Endoscopic ultrasound-guided biliary drainage (EUS-BD) is increasingly used as an alternative in patients with biliary obstruction who fail standard endoscopic retrograde cholangiopancreatography (ERCP). The two major endoscopic approach routes for EUS-BD are the transgastric intrahepatic and the transduodenal extrahepatic approaches. Biliary drainage can be achieved by three different methods, transluminal biliary stenting, transpapillary rendezvous technique, and antegrade biliary stenting. Choice of approach route and drainage method depends on individual anatomy, underlying disease, and location of the biliary stricture. Recent meta-analyses have revealed that cumulative technical success and adverse event rates were 90-94% and 16-23%, respectively. Development of new dedicated devices for EUS-BD would help refine the technical aspects and minimize the possibility of complications, making it a more promising procedure.

A Social Program for the Early Detection of Pancreatic Cancer: The Kishiwada Katsuragi Project.

OBJECTIVES: The early-stage pancreatic cancer (e-PC; stage I/II) detection rate is quite low at approximately 25%. The aim of this study was to evaluate the feasibility of a social program (the Kishiwada Katsuragi project) wherein our hospital, which specializes in PC, and primary care medical offices (PMOs) used clinical findings to detect e-PC. METHODS: Patients with a score of ≥2 points on clinical findings were enrolled: symptoms of abdominal pain/back pain (1 point), new-onset diabetes (1 point), high amylase (AMY) and/or pancreaitc AMY (P-AMY) (1 point), high carbohydrate antigen 19-9 (1 point), and ultrasonography (US) findings including direct (e.g., a solid pancreatic tumor) and/or indirect findings (e.g., dilatation of a pancreatic diameter of ≥2.5 mm and/or cystic lesions) (2 points) were evaluated using the protocol for social programs. RESULTS: Between November 2014 and December 2016, 244 patients were enrolled by 41 PMOs as cooperative facilities, and 15 e-PC cases (53.6%) of the 28 PC patients were detected. The mean clinical finding score of the e-PC group (3.13 ± 1.9) was significantly higher than that of the overall non-PC group (2.1 ± 0.4) (p < 0.05). "High AMY/P-AMY" and "symptoms" were significantly more frequent in the e-PC group than in the non-PC group (p < 0.05). Although the sensitivity of direct findings by US was 40.0%, that of indirect-findings was 93.3% in the e-PC group. Nine and 6 of the 15 patients with e-PC were enrolled via general internal medicine offices (GIMs) and other PMOs without GIMs (general surgery, n = 3; urology, n = 2; otolaryngology, n = 1). CONCLUSION: This social program with collaborations between medical centers that specialize in PC and PMOs used clinical findings, suggesting that not only GIMs but also other PMOs and indirect findings by US may play an important role in improving the e-PC detection rate.

Asian consensus statements on endoscopic management of walled-off necrosis. Part 2: Endoscopic management.

Walled-off necrosis (WON) is a new term for encapsulated necrotic tissue after severe acute pancreatitis. Various terminologies such as pseudocyst, necroma, pancreatic abscess, and infected necrosis were previously used in the literature, resulting in confusion. The current and past terminologies must be reconciled to meaningfully interpret past data. Recently, endoscopic necrosectomy was introduced as a treatment option and is now preferred over surgical necrosectomy when the expertise is available. However, high-quality evidence is still lacking, and there is no standard management strategy for WON. The consensus meeting aimed to clarify the diagnostic criteria for WON and the role of endoscopic interventions in its management. In the Consensus Conference, 27 experts from eight Asian countries took an active role and examined key clinical aspects of WON diagnosis and endoscopic management. Statements were crafted based on literature review and expert opinion, employing the modified Delphi method. All statements were substantiated by the level of evidence and the strength of the recommendation. We created 27 consensus statements for WON diagnosis and management, including details of endoscopic procedures. When there was not enough solid evidence to support the statements, this was clearly acknowledged to facilitate future research. Proposed management strategies were formulated and are illustrated using flow charts. These recommendations, which are based on the best current scientific evidence and expert opinion, will be useful for guiding endoscopic management of WON. Part 2 of this statement focused on the endoscopic management of WON.

Multicenter randomized control study of the efficacy of SO clip in colorectal endoscopic submucosal dissection (ESD). (SO clip study in colorectal ESD): Randomized controlled trial.

INTRODUCTION: Endoscopic submucosal dissection (ESD) allows the en bloc resection of colorectal epithelial tumors regardless of size. Although ESD is minimally invasive and yields favorable outcomes, it is technically difficult and requires a long procedure time. In addition, colorectal ESD is associated with a particularly high risk of complications, due to the thin bowel wall, bowel flexion, and peristalsis.Direct visualization of the submucosal layer by traction of the lesion after mucosal dissection would make ESD performance easier. S-O clips traction lesions toward the lumen, facilitating direct visualization of the submucosal layer, resulting in efficient dissection due to the traction effect and adequate dissection depth. Use of this traction device can contribute to shortening the procedure time and reducing the risk of complications. This multicenter randomized controlled trial will evaluate the usefulness of the S-O clip in colorectal ESD and assess the procedure time and frequency of complications associated with the procedure. METHODS/DESIGN: This multicenter, randomized control trial will enroll 200 patients at 4 hospitals in Japan undergoing ESD for colorectal epithelial tumors. Patients who meet the inclusion and exclusion criteria will be randomized to undergo ESD using S-O clips or conventional ESD. Patients will be randomized by a computer-generated random sequence with stratification by operator experience (trainee or expert), tumor location (colon/rectum), and institution. The primary endpoint will be ESD procedure time, defined as the time from the start of the local injection into the submucosal layer to the end of dissection. Other outcomes will include the rates of procedural complications, en bloc resection and cure. DISCUSSION: ESD using the S-O clip is expected to shorten procedure time, reduce the incidence of adverse events, and standardize the procedure. This study may resolve clinical questions about whether ESD using the S-O clip traction device is more effective and safer than conventional ESD.

Evaluation of anti-migration properties of biliary covered self-expandable metal stents.

AIM: To assess anti-migration potential of six biliary covered self-expandable metal stents (C-SEMSs) by using a newly designed phantom model. METHODS: In the phantom model, the stent was placed in differently sized holes in a silicone wall and retracted with a retraction robot. Resistance force to migration (RFM) was measured by a force gauge on the stent end. Radial force (RF) was measured with a RF measurement machine. Measured flare structure variables were the outer diameter, height, and taper angle of the flare (ODF, HF, and TAF, respectively). Correlations between RFM and RF or flare variables were analyzed using a linear correlated model. RESULTS: Out of the six stents, five stents were braided, the other was laser-cut. The RF and RFM of each stent were expressed as the average of five replicate measurements. For all six stents, RFM and RF decreased as the hole diameter increased. For all six stents, RFM and RF correlated strongly when the stent had not fully expanded. This correlation was not observed in the five braided stents excluding the laser cut stent. For all six stents, there was a strong correlation between RFM and TAF when the stent fully expanded. For the five braided stents, RFM after full stent expansion correlated strongly with all three stent flare structure variables (ODF, HF, and TAF). The laser-cut C-SEMS had higher RFMs than the braided C-SEMSs regardless of expansion state. CONCLUSION: RF was an important anti-migration property when the C-SEMS did not fully expand. Once fully expanded, stent flare structure variables plays an important role in anti-migration.

Urgent endoscopic ultrasound-guided choledochoduodenostomy for acute obstructive suppurative cholangitis-induced sepsis.

Acute obstructive suppurative cholangitis (AOSC) due to biliary lithiasis is a life-threatening condition that requires urgent biliary decompression. Although endoscopic retrograde cholangiopancreatography (ERCP) with stent placement is the current gold standard for biliary decompression, it can sometimes be difficult because of failed biliary cannulation. In this retrospective case series, we describe three cases of successful biliary drainage with recovery from septic shock after urgent endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) was performed for AOSC due to biliary lithiasis. In all three cases, technical success in inserting the stents was achieved and the patients completely recovered from AOSC with sepsis in a few days after EUS-CDS. There were no procedure-related complications. When initial ERCP fails, EUS-CDS can be an effective life-saving endoscopic biliary decompression procedure that shortens the procedure time and prevents post-ERCP pancreatitis, particularly in patients with AOSC-induced sepsis.

International consensus guidelines on interventional endoscopy in chronic pancreatitis. Recommendations from the working group for the international consensus guidelines for chronic pancreatitis in collaboration with the International Association of Pancreatology, the American Pancreatic Association, the Japan Pancreas Society, and European Pancreatic Club

This paper is part of the international consensus guidelines on chronic pancreatitis, presenting for interventional endoscopy. An international working group with experts on interventional endoscopy evaluated 26 statements generated from evidence on 9 clinically relevant questions. The Grading of Recommendations Assessment, Development, and Evaluation approach was used to evaluate the level of evidence. To determine the level of agreement, a nine-point Likert scale was used for voting on the statements. Strong consensus was obtained for 15 statements relating to nine questions including the recommendation that endoscopic intervention should be offered to patients with persistent severe pain but not to those without pain. Endoscopic decompression of the pancreatic duct could be used for immediate pain relief, and then offered surgery if this fails or needs repeated endoscopy. Endoscopic drainage is preferred for portal-splenic vein thrombosis and pancreatic fistula. A plastic stent should be placed and replaced 2­3 months later after insertion. Endoscopic extraction is indicated for stone fragments remaining after ESWL. Interventional treatment should be performed for symptomatic/complicated pancreatic pseudocysts. Endoscopic treatment is recommended for bile duct obstruction and afterwards surgery if this fails or needs repeated endoscopy. Surgery may be offered if there is significant calcification and/or mass of the pancreatic head. Percutaneous endovascular treatment is preferred for hemosuccus pancreaticus. Surgical treatment is recommended for duodenal stenosis due to chronic pancreatitis. This international expert consensus guideline provides evidenced-based statements concerning indications and key aspects for interventional endoscopy in the management of patients with chronic pancreatitis.