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

Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03133026
• Other study ID #: AIG-001
• Status: Recruiting
• Phase: N/A
• First received: April 25, 2017
• Last updated: April 25, 2017
• Start date: June 2016
• Est. completion date: July 2018

Study information

• Verified date: April 2017
• Source: Asian Institute of Gastroenterology, India
• Contact: Mohan Ramchandani, MD DM
• Phone: 9701335444
• Email: ramchandanimohan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Jaundice
• Jaundice, Obstructive
• Obstructive Jaundice

Intervention

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

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful restoration of bile duct drainage	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	Resolution of cholangitis	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