Background and Aims Radiofrequency ablation (RFA) has been used as a valuable treatment modality for various unresectable malignancies. EUS-guided radiofrequency ablation (EUS-RFA) of the porcine ...pancreas was reported to be feasible and safe in our previous study, suggesting that EUS-RFA may be applicable as an adjunct and effective alternative treatment method for unresectable pancreatic cancer. This study aimed to assess the technical feasibility and safety of EUS-RFA for unresectable pancreatic cancer. Methods An 18-gauge endoscopic RFA electrode and a radiofrequency generator were used for the procedure. The length of the exposed tip of the RFA electrode was 10 mm. After insertion of the RFA electrode into the mass, the radiofrequency generator was activated to deliver 20 to 50 W ablation power for 10 seconds. Depending on tumor size, the procedure was repeated to sufficiently cover the tumor. Results EUS-RFA was performed successfully in all 6 patients (median age 62 years, range 43-73 years). Pancreatic cancer was located in the head (n = 4) or body (n = 2) of the pancreas. The median diameter of masses was 3.8 cm (range 3cm-9cm). Four patients had stage 3 disease, and 2 patients had stage 4 disease. After the procedure, 2 patients experienced mild abdominal pain, but there were no other adverse events such as pancreatitis or bleeding. Conclusions EUS-RFA could be a technically feasible and safe option for patients with unresectable pancreatic cancer.
Background and Aims Although fully covered self-expandable metal stents (FCSEMSs) have been commonly used for EUS-guided biliary drainage (EUS-BD), FCSEMS migration is a main limitation of this ...procedure. In the present study we evaluated the technical and clinical success rates, adverse events, and long-term outcomes of a newly developed hybrid stent that has been customized for EUS-BD. Methods From September 2011 to May 2015, 54 consecutive patients with biliary obstruction were enrolled in this prospective, observational study. These patients were candidates for alternative BD techniques because of failed ERCP. The hybrid metal stent used for EUS-BD in this study was partially covered, had anchoring flaps, and is commercially available in Korea. Results EUS-guided hepaticogastrostomy (EUS-HGS) was performed in 21 patients and EUS-guided choledochoduodenostomy (EUS-CDS) in 33 patients. The technical and clinical success rates of EUS-BD were 100% (54/54) and 94.4% (51/54), respectively. Immediate adverse events developed after EUS-BD in 9 patients (16.6%; cholangitis in 3, bleeding in 2, self-limited pneumoperitoneum in 3, and abdominal pain in 1). Proximal or distal stent migration was not observed during the follow-up period (median, 148.5 days; IQR, 79.7-244), and the mean stent patency duration was 166.3 days and 329.1 days in the EUS-HGS and EUS-CDS groups, respectively. Conclusions EUS-BD with the hybrid metal stent is technically feasible and can effectively treat biliary obstruction after failed ERCP. EUS-BD with the hybrid metal stent can reduce stent-related adverse events, especially stent migration.
Background EUS-guided biliary drainage (EUS-BD) has been proposed as an effective alternative for percutaneous transhepatic biliary drainage (PTBD) after failed ERCP. To date, the risk factors for ...adverse events and long-term outcomes of EUS-BD with transluminal stenting (EUS-BDS) have not been fully explored. Objective To evaluate risk factors for adverse events and long-term outcomes of EUS-BDS. Design Prospective follow-up study. Setting Tertiary-care academic center. Patients This study involved 57 consecutive patients with malignant or benign biliary obstruction undergoing EUS-BDS after failed ERCP. Intervention EUS-guided hepaticogastrostomy (EUS-HGS) and EUS-guided choledochoduodenostomy with transluminal stenting (EUS-CDS). Main Outcome Measurements Risk factors for postprocedure and late adverse events and clinical outcomes of EUS-BDS. Results The overall technical and functional success rates, respectively, in the EUS-BDS group were 96.5% (intention-to-treat, n = 55/57) and 89% (per-protocol, n = 49/55). Postprocedure adverse events developed after EUS-BDS in 11 patients (20%, n = 11/55). This included bile peritonitis (n = 2), mild bleeding (n = 2), and self-limited pneumoperitoneum (n = 7). In multivariate analysis, needle-knife use was the single risk factor for postprocedure adverse events after EUS-BDS (odds ratio 12.4; P = .01). A late adverse event in EUS-BDS was distal stent migration (7%, n = 4/55). The mean stent patencies with EUS-HGS and EUS-CDS were 132 days and 152 days, respectively. Limitations Single-operator performed, nonrandomized study. Conclusion EUS-HGS and EUS-CDS may be relatively safe and can be used as an alternative to PTBD after failed ERCP. Both techniques offer durable and comparable stent patency. The use of a needle-knife for fistula dilation in EUS-BDS should be avoided if possible.
Background EUS-guided biliary drainage (EUS-BD) was introduced as an effective alternative to percutaneous transhepatic biliary drainage after failed ERCP. However, EUS-BD is technically challenging. ...The intraductal manipulation of the guidewire seems to be the most difficult stage of the procedure. Therefore, technical advances in guidewire manipulation may be required for EUS-BD. Objective To evaluate our treatment algorithm for guidewire manipulation protocol for EUS-BD after failed ERCP. Design Prospective, observational cohort study. Setting A tertiary-care academic center. Patients Forty-five consecutive patients undergoing EUS-BD failed ERCP. Interventions Enhanced guidewire manipulation protocol (with a plane parallel to the long axis of the bile duct with an EUS needle tip or a new 0.025-inch guidewire in an extrahepatic approach and intrahepatic bile duct puncture of segment 2 and 4F cannula with guidewire probing in the intrahepatic approach) for rendezvous and antegrade therapy, EUS-BD with transluminal stenting for duodenal invasion, and crossover to another technique if each technique failed. Main Outcome Measurements Technical and functional success rates and adverse event rate of the current treatment algorithm for EUS-BD. Results The overall technical and functional success rates of EUS-BD in this study were 91% (intention to treat, n = 41/45) and 95% (per protocol, n = 39/41), respectively. Specifically, rendezvous (n = 20) and antegrade therapy (n = 14) were initially feasible in 34 of 45 patients (76%). With our protocol, 25 of 45 patients (56%) were eventually treated with rendezvous and antegrade therapy as a first-line or crossover treatment. EUS-guided biliary drainage with transluminal stenting in patients with duodenal invasion or failed antegrade therapy was feasible in the remaining 20 patients (44%). The overall adverse event rate of EUS-BD was 11%. Limitations Single-operator, nonrandomized study. Conclusions In this prospective study, our treatment algorithm with an enhanced guidewire manipulation protocol appeared to be technically feasible and effective. Given the favorable success rate and acceptable adverse event rate, this may be considered the standard treatment algorithm for future randomized trials of EUS-BD and percutaneous transhepatic biliary drainage.
Background and Aims Preoperative biliary drainage (PBD) with stent placement has been commonly used for patients with malignant biliary obstruction. In PBD, the placement of fully covered ...self-expandable metal stents (FCSEMSs) may provide better patency duration and a lower incidence of cholangitis compared with plastic stents. We aimed to evaluate which type of stent showed better outcomes in PBD. Methods In this multicenter, prospective randomized trial, we compared PBD with FCSEMSs versus plastic stents in 86 patients with malignant biliary obstruction between January 2012 and December 2014. Patients with obstructive jaundice were randomly assigned to undergo PBD either with plastic stents or FCSEMS placement. Results Baseline characteristics were not significantly different between the 2 groups. Endoscopic stent placement was technically successful in all patients. Procedure-related adverse events were not significantly different between the 2 groups (plastic vs FCSEMS group; 16.3% vs 16.3%, P = 1.0). Reintervention was required in 16.3% of the plastic stent group and 14.0% of the FCSEMS group ( P = .763). The interval to surgery after PBD (plastic vs FCSEMS group; 14.2 ± 8.3 vs 12.3 ± 6.9 days, P = .426) was not significantly different between groups. Surgery-related adverse events occurred in 43.6% of the plastic stent group and 40.0% of the FCSEMS group ( P = .755). Conclusions In patients with resectable malignant biliary obstruction, the outcomes of PBD with plastic stents and FCSEMSs were similar. Considering the cost-effectiveness, PBD with plastic stents may be preferable to FCSEMS placement. (Clinical trial registration number: NCT01789502 .)
Background The differential diagnosis between benign and malignant polyps of the gallbladder (GB) is often challenging. Objectives To evaluate whether contrast-enhanced harmonic EUS (CEH-EUS) might ...be an accurate method for discriminating malignant GB polyps from benign polyps. Design Observational study. Setting Tertiary care medical center. Patients Ninety-three patients with GB polyps larger than 10 mm in diameter that were detected by conventional EUS underwent CEH-EUS for evaluation of microvasculature. Intervention CEH-EUS was performed using a radial echoendoscope and the extended pure harmonic detection mode. Main Outcome Measurements The abilities of conventional EUS and CEH-EUS to diagnose malignant polyp were compared. Two blinded reviewers classified the perfusion images into 3 categories: diffuse enhancement, perfusion defect, or nonenhancement. The vessel images were categorized as having a regular spotty vessel, an irregular vessel, or no vessels. Results An irregular vessel pattern determined by CEH-EUS aided in the diagnosis of malignant polyps with a sensitivity and specificity of 90.3% and 96.6%, respectively. The presence of perfusion defects, determined by CEH-EUS, was calculated to diagnose malignant polyps with a sensitivity and specificity of 90.3% and 94.9%, respectively. Based on the definitely determined diagnosis, sensitivity and specificity for CEH-EUS were 93.5% and 93.2% versus 90.0% and 91.1% for conventional EUS. In 8 cases, management changed after CEH-EUS. Limitations A tertiary medical center with a limited number of patients. Conclusions The presence of irregular intratumoral vessels or perfusion defects seen on CEH-EUS may be sensitive and accurate predictors of malignant GB polyps. CEH-EUS offers slightly improved diagnostic accuracy compared with EUS.
Background and Aims Recently, EUS-guided pancreatic duct drainage (EUS-PD) has been used for patients in whom endoscopic retrograde pancreatography (ERP) has failed. Stent-related adverse events such ...as stent migrations, failures in stent placement, or pancreatic fluid leakages have been of concern in transmural plastic stenting procedures. The aim of this study is to evaluate the feasibility and safety of EUS-PD with a fully covered self-expandable metal stent (FCSEMS) for patients with obstructive pancreatitis who failed ERP. Methods Twenty-five consecutive patients with painful obstructive pancreatitis underwent EUS-PD with a FCSEMS after failed ERP. Technical and clinical success, adverse events, and stent patency were assessed. Results EUS-PD was successful in all 25 patients (technical success rate, 100%), and symptoms improved in all patients (clinical success rate, 100%). EUS-guided pancreaticogastrostomy (n = 23), pancreaticoduodenostomy (n = 1), and pancreaticojejunostomy (n = 1) were performed. Pain scores improved significantly after FCSEMS placement ( P = .001). Early mild grade adverse events occurred in 5 patients (20%), 4 with self-limited abdominal pain and 1 with minor bleeding. No other adverse events related to FCSEMS, including stent migration, stent clogging, pancreatic sepsis, and stent-induced ductal stricture, were observed during follow-up periods. Mean stent patency duration was 126.9 days during mean follow-up periods (221.1 days). Conclusions EUS-PD with an FCSEMS may be technically feasible and relatively safe for patients who fail conventional ERP. Further randomized trials comparing EUS-PD with long-term FCSEMS and plastic stents for patients with painful obstructive pancreatitis after failed ERCP should be encouraged.
Background EUS-guided biliary drainage (EUS-BD) has emerged as an alternative rescue method in patients with failed ERCP. Opportunities for teaching and training are limited because of a low case ...volume at most centers. Objective To evaluate a stereolithography/3-dimensional (3D) printing bile duct prototype for teaching and training in EUS-BD. Design Prospective observational feasibility study. Setting Tertiary referral center. Subjects Twenty endosonographers attending an interventional EUS workshop. Intervention A prototype of a dilated biliary system was prepared by computer-aided design and 3D printing. The study participants performed guidewire manipulation and EUS-BD procedures (antegrade procedure and/or choledochoduodenostomy) on the prototype. Participants were scored with the device on a scale of 1 to 5 via a questionnaire. Participants’ success rate for various steps of the EUS-BD procedure was noted. Main Outcome Measurements Subjective and objective evaluation of the prototype regarding its overall applicability, quality of radiographic and EUS images, and 4 steps of EUS-BD procedure (needle puncture, guidewire manipulation, tract dilation, stent placement). Results Fifteen participants returned the questionnaire, and 10 completed all 4 steps of EUS-BD. The median score for overall utility was 4, whereas that for EUS and US views was 5. Participants with experience in performing more than 20 EUS-BD procedures scored the prototype significantly lower for stent placement ( P = .013) and equivalent for needle puncture, tract dilation, and wire manipulation. The success rate of various steps was 100% for needle puncture and tract dilation, 82.35% for wire manipulation, and 80% for stent placement. The mean overall procedure time was 18 minutes. Limitations Small number of participants. Conclusion The 3D printing bile duct prototype appears suitable for teaching of and training in the various steps of EUS-BD. Further studies are required to elucidate its role.
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