S2170 Currently Available Guidewire Locking Device (GLD) Designs in the Market Can Deform Expensive Endoscopic Retrograde Cholangiopancreatography (ERCP) Accessories and Compromise the Integrity of Guidewires

Introduction: GLDs used in ERCP secure guidewires and prevent fluid reflux through the biopsy channel. However, their internal design may create resistance during accessory insertion, and overly tight seals can deform devices, impacting procedural success. Repeated locking–unlocking cycles, especially in the presence of bile and contrast, may compromise the polytetrafluoroethylene (PTFE) coating on guidewires. This study aimed to evaluate the impact of current GLD designs on ERCP accessory integrity and guidewire durability. Methods: Three commercial GLDs were tested using a validated Newton gauge. We measured the force required to permanently deform 3 ERCP accessories—sphincterotome, stone-extraction balloon, and dilating balloon—and the insertion force for each (10 insertions/accessory/GLD). PTFE integrity of guidewires exposed to bile and contrast was evaluated after ≥15 lock–unlock cycles. Damage was categorized as holes, fraying, or linear fractures, and scored 1–3 (1 = none, 3 = severe). ANOVA was used for comparisons. Deformation was also assessed as a binary variable (above vs below threshold), with odds ratios calculated. Results: The force required to permanently deform the sphincterotome was 4.70 N, stone-extraction balloon 1.60 N, and dilating balloon 0.88 N. Insertion forces differed significantly across GLDs for each accessory. For sphincterotomes, mean forces were: GLD#1 = 5.21 ± 0.94 N, GLD#2 = 5.41 ± 0.35 N, and GLD#3 = 2.47 ± 0.22 N (F = 62.1, P < 0.001); only GLD#3 did not cause deformation. For stone-extraction balloons: GLD#1 = 6.16 ± 0.22 N, GLD#2 = 11.49 ± 0.72 N, GLD#3 = 2.62 ± 0.25 N (F = 970.3, P < 0.001); again, only GLD#3 remained below the deformation threshold. For CRE balloons: GLD#1 = 5.92 ± 0.20 N, GLD#2 = 5.54 ± 0.30 N, GLD#3 = 2.68 ± 0.20 N; however, all 3 exceeded the deformation threshold. When analyzed as a binary outcome, GLD#3 had zero deformation events in sphincterotome and stone balloon testing, while GLD#1 and GLD#2 had 100%, yielding significant odds ratios favoring GLD#3 (P < 0.005 for all comparisons). PTFE integrity analysis showed severe damage with GLD#2 (score: 8/9; holes and fractures), moderate with GLD#1 (5/9), and mild with GLD#3 (3/9). Conclusion: GLD designs vary in insertion resistance, with some exceeding deformation thresholds for ERCP devices. Repeated lock–unlock cycles, particularly with bile and contrast, can damage guidewire PTFE coating. Design refinements are needed to minimize device damage, cost, and risk.