Clinical Evaluation of a Newly Developed Guidewire for Pancreatobiliary Endoscopy

Abstract

Background: The guidewire (GW) plays an important role in pancreatobiliary endoscopy. GW quality is a critical factor in the effectiveness and efficiency of pancreatobiliary endoscopy. In this study, we evaluate a new 0.025 inch multipurpose endoscopic GW: the M-Through. Methods: Our study was a multicenter retrospective analysis. We enrolled patients who underwent endoscopic procedures using the M-Through between May 2018 and April 2020. Patients receiving the following endoscopic treatments were enrolled: common bile duct (CBD) stone extraction, endoscopic drainage for distal and hilar malignant biliary obstruction (MBO), and endoscopic drainage for acute cholecystitis. For each procedure, we examined the rate of success without GW exchange. Results: A total of 170 patients (80 with CBD stones, 60 with MBO, and 30 with cholecystitis) were enrolled. The rate of completion without GW exchange was 100% for CBD stone extraction, 83.3% for endoscopic drainage for MBO, and 43.3% for endoscopic drainage for cholecystitis. In unsuccessful cholecystitis cases with the original GW manipulator, 1 of 8 cases succeeded in the manipulator exchange. Including 6 cases who changed GW after the manipulator exchange, 11 of 16 cases succeeded in changing GW. There was significant difference in the success rate between the manipulator exchange and GW exchange (p = 0.03). The insertion of devices and stent placement after biliary cannulation (regardless of type) were almost completed with M-through. We observed no intraoperative GW-related adverse events such as perforation and bleeding due to manipulation. Conclusion: The 0.025 inch M-Through can be used for endoscopic retrograde cholangiopancreatography-related procedures efficiently and safely. Our study found high rates of success without GW exchange in all procedures except for endoscopic drainage for cholecystitis. This GW is considered (1) excellent for supportability of device insertion to remove CBD stones; (2) good for seeking the biliary malignant stricture but sometimes need the help of a hydrophilic GW; (3) suboptimal for gallbladder drainage that require a high level of seeking ability.

Comparison of guidewires for successful cannulation of biliary stenosis and targeting of biliary branches in ERCP

“…However, there is still a need for better guidewires to be developed. Even though many guidewires have been developed and are available, comparing the usefulness of different guidewires in clinical practice remains difficult [10,11]. Although some model tests have been carried out, the clinical relevance of their results remains unclear [12,13], Endoscopists, therefore, are faced with the problem of which guidewire to use.…”

Structural factors influencing the clinical performance of 0.025-inch guidewires for pancreatobiliary endoscopy: An experimental study

“…Guidewires are essential to endoscopic retrograde cholangiopancreatography (ERCP) [1,2]. Conventionally, 0.035-inch guidewires have been used; recently, highperformance 0.025-inch guidewires have been developed and frequently used [3][4][5][6].…”

“…Guidewires are essential to endoscopic retrograde cholangiopancreatography (ERCP) [1,2]. Conventionally, 0.035-inch guidewires have been used; recently, high-performance 0.025inch guidewires have been developed and frequently used [3,4,5,6]. In addition, 0.025-inch guidewires have been used for endoscopic ultrasound-guided biliary drainage (EUS-BD) procedures [7,8].…”

Recent Advances in Pancreato-Biliary Endoscopic Intervention: How to Resolve Unmet Needs in Pancreato-Biliary Diseases Endoscopically

“…Guidewires are indispensable for endoscopic procedures; however, there remains no ideal guidewire. Alternative efforts toward developing and evaluating devices for endoscopic procedures have been critical in increasing the efficiency of our procedure [3]. Further development of strategies and devices are needed to resolve the unmet needs in this field.…”

“…Performing EST to open the papilla is complicated, and retraction of common bile duct stones can be problematic even with full-length EST. EST followed by balloon dilation (ESBD) to open the papilla to retract common bile duct stones can be performed by beginner endoscopists because of the small incision with balloon dilation [3], facilitating subsequent stone retraction. Bleeding is less common with ESBD than with EST because of the small incision, and pancreatitis is less common than endoscopic papillary balloon dilation (EPBD) because of the division of the pancreas and bile duct orifice [5].…”