Cholangitis Clinical Trial
Official title:
The Role of Cholangioscopy and Biliary Radio Frequency Ablation in the Management of Occluded Biliary Self-expanding Metal Stent.
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
;
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