Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03133026
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Mohan Ramchandani, Asian Institute of Gastroenterology, India

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.


Condition or disease Intervention/treatment Phase
Obstructive Jaundice Cholangitis Device: Single operator cholangioscopy, Endoscopic biliary RFA Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Role of Cholangioscopy and Biliary Radio Frequency Ablation in the Management of Occluded Biliary Self-expanding Metal Stent.
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

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 Name: 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 Name: SpyGlass cholangioscopy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133026


Contacts
Layout table for location contacts
Contact: Mohan Ramchandani, MD DM 9701335444 ramchandanimohan@gmail.com

Locations
Layout table for location information
India
Asian Institute of Gastroenterology Recruiting
Hyderabad, Telangana, India, 500082
Contact: Mohan Ramchandani, MD DM         
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
Layout table for investigator information
Principal Investigator: Mohan Ramchandani, MD DM Asian Institute of Gastroenterology

Layout table for additonal information
Responsible Party: Mohan Ramchandani, Consultant Gastroenterologist, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT03133026     History of Changes
Other Study ID Numbers: AIG-001
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mohan Ramchandani, Asian Institute of Gastroenterology, India:
obstructive Jaundice
Self Expandable Metal Stents (SEMS)
Cholangitis

Additional relevant MeSH terms:
Layout table for MeSH terms
Cholangitis
Jaundice
Jaundice, Obstructive
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms