Clinical trial NCT03133026: Cholangioscopic Assessment of Occluded Biliary Stent and Role of Biliary Radiofrequency Ablation
Official title: The Role of Cholangioscopy and Biliary Radio Frequency Ablation in the Management of Occluded Biliary Self-expanding Metal Stent.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Jaundice
Cholangitis
Keywords: obstructive Jaundice
Self Expandable Metal Stents (SEMS)
Cholangitis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Successful restoration of bile duct drainage
timeFrame: 1 month
Secondary outcomes:
measure: Resolution of cholangitis
timeFrame: 1 week and 1 month
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Mohan Ramchandani, MD DM
role: PRINCIPAL_INVESTIGATOR
References: