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

Asian Institute of Gastroenterology, India

Status: Unknown

Conditions: Cholangitis; Obstructive Jaundice

Treatments: Device: Single operator cholangioscopy, Endoscopic biliary RFA

Study type: Interventional

Funder types: Other

Identifiers

NCT03133026

AIG-001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 4 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Sludge group

Active Comparator group

Description:

If Single operator cholangioscopy reveals only sludge then sludge will be cleared using conventional technique during ERCP.

Treatment:

Device: Single operator cholangioscopy, Endoscopic biliary RFA

Ingrowth / Overgrowth

Active Comparator group

Description:

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

Treatment:

Device: Single operator cholangioscopy, Endoscopic biliary RFA