Clinical impact of a novel device delivery system in the diagnosis of bile duct lesions: A single‐center experience

Abstract

Background and Aim Pathological evaluation is essential for the diagnosis of biliary tract diseases. However, existing evaluation methods have various challenges in terms of operability and diagnostic performance. The present study aimed to evaluate the feasibility, utility, and safety of a novel device delivery system for bile duct biopsy. Methods This study was conducted as a retrospective, descriptive analysis at a single center. Overall, 25 examinations in 14 consecutive patients who underwent transpapillary biopsies for biliary lesions using the novel device delivery system from July to November 2020 were reviewed. Number and time of biopsy, technical success rate, adequate tissue sampling rate, adverse events, and diagnostic performance of bile duct biopsies using the novel device were evaluated. Moreover, negative surgical margins were assessed in patients who underwent surgical resection after mapping biopsy. Results The median number of biopsy samples was five (range: 2–13), with a median biopsy time of 11.6 min. The technical success rate was 100% (140/140), with an adequate sampling rate of 82.9% (116/140). These rates did not differ depending on the biopsy site or purpose. There were no serious adverse events related to the procedures. The diagnostic sensitivity, specificity, and accuracy of biliary stricture were 90%, 100%, and 92.3%, respectively. Negative surgical margins were confirmed in all patients undergoing surgical resection, including one patient with a surgical procedure changed based on the results of mapping biopsy. Conclusions The novel device delivery system has potentials in diagnosing biliary tract diseases and determining appropriate treatment strategies.

Impact of a new dedicated sheath device for tissue sampling of biliary stricture on pathological diagnostic yield: Retrospective study

“…A retrospective single-center study evaluated TBFBs using this novel delivery device in 14 patients and revealed high diagnostic yields of 90% and 92.3% in sensitivity and accuracy, respectively, making it a promising method for TBFB [12]. However, there have been no comparative studies of TBFB using this novel sheath device and conventional TBFB.…”

Additional stenting for hilar cholangiocarcinoma using a novel delivery device after uncovered metallic stent placements

“…Recently, we developed a novel delivery device composed of an inner catheter with a tapered tip and an outer sheath with no caliber difference. With this device, various devices up to 6 Fr can be delivered into the bile duct through the outer sheath, which has an inner diameter of 6.5 Fr 3 4 . In this case, not only did the tapered shape and moderate stiffness of this novel device aid its passage through the U-SEMS meshes, but the outer sheath also served as a conduit for easy placement of an ENBD tube ( Fig.…”

Initial experience of transpapillary gallbladder biopsy using newly designed device delivery system

“…In 1 patient with gallbladder neck wall thickness, the gallbladder anatomy made it difficult to accurately assess whether a biopsy could be performed from the target site. The median number of biopsies was 5.5 (3)(4)(5)(6)(7)(8). Appropriate evaluable specimens were obtained in all 10 patients in which biopsies were taken from the gallbladder.…”