Endoscopic Evaluation of Premalignant Lesions in the Biliary Tract and Pancreatic Ducts
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Accuracy of single operator endoscopy plus pCLE in the biliary and pancreatic ductal system diagnosing premalignant and malignant lesions.
Study Overview
Brief 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.
Detailed Description
Diagnosis of early preneoplastic lesions is always a problem, but especially when it comes to hidden organs such as the bile ducts and the pancreas. The recent developments in endoscopy encompass mini endoscopes (mother-baby; "Spyglas®"), which allow visualization of the bile ducts and the pancreas and the possibility to take biopsies under direct vision. An even newer technique is an adaptation of the existing confocal laser scanning microscopy (CLSM) to a small probe, which fits into the 1 mm working channel of the Spyglas. This application of CLSM was coined probe-based confocal laser endomicroscopy (pCLE).
It is the aim of this project to systematically and prospectively evaluate the usefulness of pCLE in two distinct patient groups: patients with PSC prone to develop a bile duct cancer (CCC) and patients with chronic pancreatitis/family history of pancreatic cancer prone to develop pancreatic cancer or have suspected IPMN.
Patients&Methods Patients with suspected diagnosis of PSC who have to undergo ERCP for diagnosis or therapy or suspected CCC will receive Spyglass investigations under a current clinical protocol. The investigators will add pCLE to these patients.
Patients with chronic (hereditary) pancreatitis and suspected malignancy, patients with suspected premalignant lesions (e.g. IPMN), and individuals at risk from familiar pancreatic cancer syndromes who under the surveillance (MRCP with secretin) demonstrate a pancreatic pathology will undergo ERCP with Spyglass as a diagnostic procedure. In these patients, the investigators will add pCLE.
Spyglass will be introduced during ERCP and the ducts will be visually inspected. In areas of stenosis and/or suspected pathology, pCLE will be executed. Finally, these areas will be biopsied, if possible. Bile and pancreatic juice will be taken for cytology and molecular analysis. Diagnostic yield and accuracy will be determined of ERCP (x-ray), Spyglas, CLSM, and histology (PAD).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Suspicious lesions of the hepatobiliary pancreatic duct systems.
Exclusion Criteria
- •Unwillingness to participate
- •Unfit for the investigation
Outcomes
Primary Outcomes
Accuracy of single operator endoscopy plus pCLE in the biliary and pancreatic ductal system diagnosing premalignant and malignant lesions.
Time Frame: Two years
Beside the safety, technical feasibility and efficacy, we will record and calculate the diagnostic accuray by comparing the outcome of Spyglass/pCLE (endoscopic judgement) with histology (biopsy) and eventual surgical pathology. Outcome measures will be 1) diagnosis of malignant/suspicious lesion by Spyglass and/or pCLE versus final diagnosis with biopsy (Spyglass, other) and/or surgical pathology (resection).
Secondary Outcomes
No secondary outcomes reported
Investigators
Matthias Löhr
Professor
Karolinska University Hospital