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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Occurrence and severity of procedure related serious adverse events from procedure through 30 days after procedure Resolution of cholangitis where applicable 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 Improvement of biliary obstructive symptoms at 1 week and 1 month post procedure compared to Baseline Improvement of Laboratory Liver Function Tests (LFT) at 1 week and 1 month post procedure compared to Baseline Biliary Reintervention rate from procedure through 30 days after procedure, including reinterventions caused by plastic stent occlusion 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

Official Title
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The Role of Cholangioscopy and Biliary Radio Frequency Ablation in the Management of Occluded Biliary Self-expanding Metal Stent.

Conditions
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Obstructive Jaundice, Cholangitis

Intervention / Treatment
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* Device: Single operator cholangioscopy, Endoscopic biliary RFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age 18 or older 2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study 3. Recurrent biliary obstructive symptoms after biliary SEMS placement 4. Biliary SEMS occlusion. Exclusion Criteria: 1. Contraindications for endoscopic techniques 2. Ongoing cholangitis. NOTE: In case a patient presents who meets the inclusion and exclusion criteria, but has cholangitis, then a naso-biliary drain (NBD) will be placed before the ERCP until the cholangitis resolves.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sludge group<br>If Single operator cholangioscopy reveals only sludge then sludge will be cleared using conventional technique during ERCP. | Device: Single operator cholangioscopy, Endoscopic biliary RFA<br>* Single operator cholangioscopy will be done to acess the cause of occluded SEMS, if tumour ingrowth or overgrowth seen then endoscopic biliary RFA will be done<br>* Other names: SpyGlass cholangioscopy;|
| Active Comparator: Ingrowth / Overgrowth<br>If Single operator cholangioscopy reveals tumour ingrowth or overgrowth then to evaluate the role of biliary RFA for occluded stent due to tumour ingrowth or overgrowth | Device: Single operator cholangioscopy, Endoscopic biliary RFA<br>* Single operator cholangioscopy will be done to acess the cause of occluded SEMS, if tumour ingrowth or overgrowth seen then endoscopic biliary RFA will be done<br>* Other names: SpyGlass cholangioscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful restoration of bile duct drainage | 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 followup. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of cholangitis | 1. Occurrence and severity of procedure related serious adverse events from procedure through 30 days after procedure 2. Resolution of cholangitis where applicable 4. Improvement of biliary obstructive symptoms at 1 week and 1 month post procedure compared to Baseline 5. Improvement of Laboratory Liver Function Tests (LFTs) at 1 week and 1 month post procedure compared to Baseline | 1 week and 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangitis, obstructive Jaundice, Self Expandable Metal Stents (SEMS)