Cholangioscopic Assessment of Occluded Biliary Stent and Role of Biliary Radiofrequency Ablation

Overview

Primary Objective: To document state-of- the-art multi-modality management of occluded biliary SEMS aiming to minimize number of reinterventions while providing symptom relief without procedure-related serious adverse events. NOTE: This study will be hypothesis-generating for an anticipated randomized controlled study (RCT) to compare outcomes of placement of a plastic stent inside the occluded SEMS to outcomes of the proposed multi-modality approach.

Study Design: Prospective, multi-center, single arm, post market, observational study Two groups: * Sludge group: SEMS occluded due to sludge/stones in SEMS * Ingrowth/overgrowth group: SEMS occluded due to malignant tumor ingrowth or benign hyperplastic tissue overgrowth Primary Endpoint: Successful restoration of bile duct drainage with biliary obstructive symptom and cholangitis relief as applicable, without procedure related SAE'S, from procedure through 30 days of follow-up. Secondary Endpoints: 1. Occurrence and severity of procedure related serious adverse events from procedure through 30 days after procedure 2. Resolution of cholangitis where applicable 3. Technical success of procedure performed for restoration of bile duct drainage, overall and stratified by treatment group Sludge group: Ability to restore stent patency by cleaning the stent content followed by cholangiographically or cholangioscopically confirmed restored stent patency Ingrowth / overgrowth group: Ability to perform biliary radio frequency ablation (RFA) followed by cholangiographically or cholangioscopically confirmed restored stent patency 4. Improvement of biliary obstructive symptoms at 1 week and 1 month post procedure compared to Baseline 5. Improvement of Laboratory Liver Function Tests (LFT) at 1 week and 1 month post procedure compared to Baseline 6. Biliary Reintervention rate from procedure through 30 days after procedure, including reinterventions caused by plastic stent occlusion 7. Impact of cholangioscopy on current standard of care, which is to place a stent inside the occluded SEMS by * Avoiding placement of a second stent (plastic or metal) * Avoiding a repeat ERCP * Reducing associated cost

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Central Contacts