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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03133026

Enrollment

Registered

2017-04-28

Start date

2016-06-30

Completion date

2018-07-31

Last updated

2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangitis, Obstructive Jaundice

Keywords

obstructive Jaundice, Self Expandable Metal Stents (SEMS), Cholangitis

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

Interventions

DEVICESingle operator cholangioscopy, Endoscopic biliary RFA

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Successful restoration of bile duct drainage	1 month	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.

Secondary

Measure	Time frame	Description
Resolution of cholangitis	1 week and 1 month	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

Countries

India

Contacts

Primary ContactMohan Ramchandani, MD DM

ramchandanimohan@gmail.com9701335444

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026