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

April 25, 2017 updated by: Mohan Ramchandani, Asian Institute of Gastroenterology, India

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Asian Institute of Gastroenterology
        • Contact:
          • Mohan Ramchandani, MD DM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sludge group
If Single operator cholangioscopy reveals only sludge then sludge will be cleared using conventional technique during ERCP.
Device: Single 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
Other Names:
  • SpyGlass cholangioscopy
Active Comparator: Ingrowth / Overgrowth
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
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
Other Names:
  • SpyGlass cholangioscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful restoration of bile duct drainage
Time Frame: 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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of cholangitis
Time Frame: 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
1 week and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Investigators

  • Principal Investigator: Mohan Ramchandani, MD DM, Asian Institute of Gastroenterology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIG-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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