An interventional study of Single operator cholangioscopy, Endoscopic biliary RFA in Obstructive Jaundice and Cholangitis, sponsored by Asian Institute of Gastroenterology, India. Status unknown at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-04-28.
Sponsored by Asian Institute of Gastroenterology, India · Not applicable, Interventional, and Diagnostic
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 Design:
Prospective, multi-center, single arm, post market, observational study
Two groups:
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:
Impact of cholangioscopy on current standard of care, which is to place a stent inside the occluded SEMS by
62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.
This study's planned enrollment of 4 is below the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.
Browse Jaundice, Obstructive studies →Asian Institute of Gastroenterology, India is the lead sponsor of 135 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
If Single operator cholangioscopy reveals only sludge then sludge will be cleared using conventional technique during ERCP.
Device: Single operator cholangioscopy, Endoscopic biliary RFA
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
Also known as: SpyGlass cholangioscopy
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.
Time frame: 1 month
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
Time frame: 1 week and 1 month
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jun 2016, a primary completion of Jun 2018 and a completion of Jul 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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