Obstructive JaundiceNCT03133026
Cholangioscopic Assessment of Occluded Biliary Stent and Role of Biliary Radiofrequency Ablation
A study testing Single operator cholangioscopy, Endoscopic biliary RFA in people with Obstructive Jaundice and Cholangitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Jaundice, Cholangitis
- What is being tested?
- Single operator cholangioscopy, Endoscopic biliary RFA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082
Mohan Ramchandani, MD DM
About this study
Official title: 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.
Read the 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:
- Occurrence and severity of procedure related serious adverse events from procedure through 30 days after procedure
- Resolution of cholangitis where applicable
- 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
- Improvement of biliary obstructive symptoms at 1 week and 1 month post procedure compared to Baseline
- Improvement of Laboratory Liver Function Tests (LFT) at 1 week and 1 month post procedure compared to Baseline
- Biliary Reintervention rate from procedure through 30 days after procedure, including reinterventions caused by plastic stent occlusion
- 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
- Conditions
- Obstructive Jaundice, Cholangitis
- Being tested
- Single operator cholangioscopy, Endoscopic biliary RFA
- Keywords
- obstructive Jaundice, Self Expandable Metal Stents (SEMS), Cholangitis
- Medical subject headings
- Jaundice, Obstructive, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single operator cholangioscopy, Endoscopic biliary RFADevice
Also called SpyGlass cholangioscopy
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 group | Role | What they receive |
|---|---|---|
| Sludge group | Active comparator | If Single operator cholangioscopy reveals only sludge then sludge will be cleared using conventional technique during ERCP. Receives: Device: Single operator cholangioscopy, Endoscopic biliary RFA |
| Ingrowth / Overgrowth | Active comparator | 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 Receives: Device: Single operator cholangioscopy, Endoscopic biliary RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
Resolution of cholangitis
- 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
Measured: 1 week and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive JaundiceStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Mohan Ramchandani, MD DM, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133026
- Sponsor's protocol ID
- AIG-001
- Status last verified
- Apr 2017
- First submitted
- 25 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cholangioscopy and Biliary Radio Frequency Ablation in the Management of Occluded Biliary Self-expanding Metal Stent.
- ClinicalTrials.gov ID
- NCT03133026
- Acronym / sponsor ID
- AIG-001
- Conditions
- Obstructive Jaundice, Cholangitis
- Keywords
- obstructive Jaundice, Self Expandable Metal Stents (SEMS), Cholangitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Occurrence and severity of procedure related serious adverse events from procedure through 30 days after procedure
- Resolution of cholangitis where applicable
- 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
- Improvement of biliary obstructive symptoms at 1 week and 1 month post procedure compared to Baseline
- Improvement of Laboratory Liver Function Tests (LFT) at 1 week and 1 month post procedure compared to Baseline
- Biliary Reintervention rate from procedure through 30 days after procedure, including reinterventions caused by plastic stent occlusion
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sludge group | Active comparator | Device: Single operator cholangioscopy, Endoscopic biliary RFAIf Single operator cholangioscopy reveals only sludge then sludge will be cleared using conventional technique during ERCP. |
| Ingrowth / Overgrowth | Active comparator | Device: Single operator cholangioscopy, Endoscopic biliary RFAIf 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single operator cholangioscopy, Endoscopic biliary RFAAlso: SpyGlass cholangioscopySingle 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 | Device | Ingrowth / Overgrowth, Sludge group |
Primary outcome
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 secondary outcome
Resolution of cholangitis
Time frame: 1 week and 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohan Ramchandani, MD DM principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single operator cholangioscopy, Endoscopic biliary RFA in people with Obstructive Jaundice and Cholangitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohan Ramchandani, MD DM (9701335444, ramchandanimohan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful restoration of bile duct drainage (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.