Cholangioscopic Assessment of Occluded Biliary Stent & Role of Biliary

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03133026
Study type	Interventional
Source	Asian Institute of Gastroenterology, India
Contact	Mohan Ramchandani, MD DM
Phone	9701335444
Email	ramchandanimohan@gmail.com
Status	Recruiting
Phase	N/A
Start date	June 2016
Completion date	July 2018

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms