A novel bipolar electrocautery-enhanced delivery system with a lumen-apposing metal stent for EUS-guided drainage: A porcine study.

BACKGROUND: An electrocautery-enhanced delivery system with a lumen-apposing metal stent (LAMS) is available for one-step endoscopic ultrasound-guided transmural drainage (EUS-TD). Bipolar electrosurgery has several potential clinical advantages, including reduced collateral thermal damage, enhanced hemostasis, and no requirement for a return electrode plate. In this study, we compared the technical feasibility and safety of a newly developed bipolar electrocautery-enhanced delivery system with a conventional delivery system for EUS-TD using a LAMS in a porcine model. METHOD: Ten days before the study, 12 mini pigs underwent common bile duct ligation for EUS-guided gallbladder drainage. Transenteric puncture was performed, followed by placement of a guidewire. In six pigs, a bipolar electrocautery-enhanced delivery system with LAMS (Hot SPAXUS) was inserted over the guidewire and advanced into the gallbladder, without prior dilation of the tract, by applying a bipolar cut current. In the remaining six pigs, a conventional delivery system with LAMS (Cold SPAXUS) was inserted after tract dilatation using a cystotome. The stent was removed after 4 weeks. RESULTS: In all pigs, the stent was successfully inserted and deployed in the gallbladder without adverse events. The mean procedure time of EUS-TD was significantly lower in the Hot SPAXUS group than that of the Cold SPAXUS group (mean ± standard deviation: 188.7 ± 5.2 vs 449.5 ± 97.5 s, P = .0019). Stent migration was not observed, and all stents were removed successfully. CONCLUSIONS: Endoscopic ultrasound-guided transmural drainage using a bipolar electrocautery-enhanced LAMS is feasible for reducing the procedure time while maintaining the high success rate and safety of conventional LAMS.

The impact of preoperative EUS-FNA for distal resectable pancreatic cancer: Is it really effective enough to take risks?

BACKGROUND AND AIMS: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is frequently used for the preoperative histologic diagnosis of pancreatic cancer. However, debate continues regarding the clinical merits of preoperative EUS-FNA for the management of resectable pancreatic cancer. We aimed to evaluate the benefits and safety of preoperative EUS-FNA for resectable distal pancreatic cancer. METHODS: The medical records of 304 consecutive patients with suspected distal pancreatic cancer who underwent EUS-FNA were retrospectively reviewed to evaluate the clinical benefits of preoperative EUS-FNA. We also reviewed the medical records of 528 patients diagnosed with distal pancreatic cancer who underwent distal pancreatectomy with or without EUS-FNA. The recurrence rates and cancer-free survival periods of patients who did or did not undergo preoperative EUS-FNA were compared. RESULTS: The diagnostic accuracy of preoperative EUS-FNA was high (sensitivity, 87.5%; specificity, 100%; positive predictive value 100%; accuracy, 90.7%; negative predictive value, 73.8%). Among patients, 26.7% (79/304) avoided surgery based on the preoperative EUS-FNA findings. Of the 528 patients who underwent distal pancreatectomy, 193 patients received EUS-FNA and 335 did not. During follow-up (median 21.7 months), the recurrence rate was similar in the two groups (EUS-FNA, 72.7%; non-EUS-FNA, 75%; P = 0.58). The median cancer-free survival was also similar (P = 0.58); however, gastric wall recurrence was only encountered in the patients with EUS-FNA (n = 2). CONCLUSION: Preoperative EUS-FNA is not associated with increased risks of cancer-specific or overall survival. However, clinicians must consider the potential risks of needle tract seeding, and care should be taken when selecting patients.

Efficacy of a modified short fully covered self-expandable metal stent for perihilar benign biliary strictures.

BACKGROUND AND AIM: Endoscopic management of a benign biliary stricture (BBS) on the hilum is complicated and challenging. Although the placement of a fully covered self-expandable metal stent (FCSEMS) is possible to increase effectiveness, stent migration and stent-induced adverse events are problematic. We aimed to evaluate the usefulness of a modified short FCSEMS with a long lasso in patients with a difficult perihilar BBS. METHODS: Patients with perihilar BBS within 2 cm from the hilar confluence that failed initially with plastic stents were enrolled. A modified short FCSEMS was deployed and then removed 5-6 months later. The primary outcome was clinical success. Other technical success, adverse events, endoscopic success of stent removal, and recurrence of stricture during the follow-up period were measured. RESULTS: Endoscopic intraductal placement was technically successful in all patients (n = 19). Combined contralateral plastic stent placement was performed in 13 patients (68.4%). The median duration of stent placement was 163 days (range, 138-196 days). Endoscopic stent removal was successful in all patients except one spontaneous distal migration. Stricture resolution without de novo focal stricture occurrence was 100%. Endoscopic stone removal after stricture improvement was successful in all 13 patients with bile duct stones above the stricture. During a follow-up period (median 635 days) after stent removal, only one recurrence developed. CONCLUSIONS: Temporary placement of a modified intraductal short FCSEMS with or without a contralateral plastic stent improved perihilar BBS in patients that primarily failed by plastic stents. Combined biliary stones were also successfully removed after stricture resolution.

Preliminary study of a modified, nonflared, short, fully covered metal stent for refractory benign pancreatic duct strictures (with videos).

BACKGROUND AND AIMS: Fully covered self-expanding metal stents (FCSEMSs) are considered to be more effective than plastic stents for the treatment of main pancreatic duct (MPD) strictures associated with chronic pancreatitis (CP) because of their larger diameter and exertion of a radial expansion force. However, the current FCSEMSs have several limitations. To overcome these, a novel modified nonflared FCSEMS was developed. In this study we conducted a prospective long-term follow-up evaluation of the efficacy of the novel FCSEMS for the treatment of refractory benign PD strictures in patients with CP. METHODS: Consecutive patients with symptomatic CP associated with refractory MPD strictures were enrolled prospectively in this single-arm study. The nonflared FCSEMS was placed intraductally or transpapillary according to the location and length of the stricture. Stent removal was performed at 3 months after placement. The primary outcome was the resolution of the pancreatic ductal stricture. RESULTS: Endoscopic placement of modified nonflared FCSEMSs was technically successful in all 25 patients. Intraductal FCSEMS placement was performed in 14 patients (56.0%). Stents of diameter 8 mm were used in 17 patients (68.0%). Stents of lengths 3 and 5 cm were inserted in 22 (88.0%) and 3 (12.0%) patients, respectively. In 1 patient (4.0%), stent migration developed. All other stents were removed successfully. After stent removal, resolution of the MPD stricture was confirmed in all patients, and no FCSEMS-related de novo stricture was observed. During the follow-up period (median, 34 months; interquartile range, 25-56) after the stents had been removed from the 25 patients, reintervention for recurrence of MPD stricture with abdominal pain was performed in 2 patients (8.0%). CONCLUSIONS: Endoscopic placement of a novel modified nonflared FCSEMS resulted in long-term stricture resolution with pain relief and reduced the rate of stent-related adverse events, particularly stent migration and stent-induced de novo MPD stricture. (Clinical trial registration number: UMIN000035681.).

Feasibility and safety of endoscopic ultrasound-guided gallbladder drainage using a newly designed lumen-apposing metal stent.

BACKGROUND AND AIMS: Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is increasingly accepted as an effective treatment option in patients who require drainage for acute cholecystitis. A newly designed lumen-apposing metal stent (LAMS) has been introduced recently in this procedure. In this study, we evaluated the feasibility and safety of the newly designed LAMS in patients with acute cholecystitis who were unsuitable for cholecystectomy. METHODS: Between Mar 2017 and Oct 2017, 22 patients with acute cholecystitis who were unsuitable for cholecystectomy underwent EUS-GBD with the newly designed LAMS. We evaluated the technical and clinical success and the adverse event profiles. RESULTS: EUS-GBD with newly designed LAMS was technically and clinically successful in 21 of the 22 patients. EUS-GB stenting was performed at urgent setting in 17 patients, while 5 patients, who had undergone initial PTGBD, underwent EUS-GB stenting to remove PTGBD tube. The median procedure time was 11.5 (range 8.8-17.0) min. A late adverse event of stent occlusion developed in one patient. Stent migration was not observed during follow-up (median 318.0 days, range 39.0-398.0 days) and cumulative stent patency rate at 1 year was 95%. CONCLUSION: EUS-GBD with newly designed LAMS is feasible and shows acceptable safety profiles for both the urgent drainage of acute cholecystitis and elective internalization following PTGBD in patients with high surgical risk.