Endoscopic Evaluation of Premalignant Lesions in the Biliary Tract and Pancreatic Ducts (NCT02057146) | Clinical Trial Compass
CompletedNot Applicable
Endoscopic Evaluation of Premalignant Lesions in the Biliary Tract and Pancreatic Ducts
Sweden50 participantsStarted 2013-10
Plain-language summary
Single operater pancreatico-cholangioscopy is performed through the working channel of conventional duodenoscopes. A visual evaluation of the biliary and pancreatic ductal systems is completed and obvious or suspicious macroscopic lesions are targeted by biopsy forceps.
Evaluation of the usefulness of probe based confocal laser endomicroscopy in the evaluation of suspected premalignant lesions in the biliary duct and in the pancreas.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Suspicious lesions of the hepatobiliary pancreatic duct systems.
Exclusion Criteria:
* Unwillingness to participate
* Unfit for the investigation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study used a combination of single-operator endoscopy and a technology called pCLE to look for early warning signs in the bile ducts and pancreas — how does that approach compare to what I'm currently being offered to evaluate my lesion?
2Since this trial is now completed, has any data or results been published that my care team could review to understand how accurate this imaging combination actually was at telling apart benign and potentially cancerous lesions?
3The trial focused on 'premalignant' lesions — meaning tissue that could turn cancerous — so how would my doctor classify where my own lesion falls on that spectrum, and does that affect whether a technique like pCLE would be relevant for me?
4Because this study is listed as 'Phase NA,' meaning it was more of a diagnostic evaluation than a treatment trial, does that mean participating in something like this carries different risks than a drug trial, and what would the procedure itself actually involve for me?
5Are there standard diagnostic tools already in use at my doctor's facility that would give me similar information to what this trial was measuring, or is the pCLE-plus-endoscopy combination something I'd need to specifically seek out at a specialized center?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of single operator endoscopy plus pCLE in the biliary and pancreatic ductal system diagnosing premalignant and malignant lesions.