Endoscopic Evaluation of Premalignant Lesions in the Biliary Tract and Pancreatic Ducts
Condition: Benign Neoplasm of Liver and/or Biliary Ducts; Neoplasm of Uncertain Behavior of Biliary System; Benign Neoplasms of the Pancreas; Neoplasms of the Pancreas
MeSH terms: Neoplasms; Precancerous Conditions; Brain Neoplasms; Liver Neoplasms; Pancreatic Neoplasms
Study type: Interventional

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).

      This will be firstly an explorative study because the diagnostic criteria for assessing
      malignancy with CLSM are under development and the investigators group as one of the few
      doing Spyglas routinely will contribute to establishing such criteria. For statistical
      calculations, a total of 100 patients will be necessary. It is their plans to do this
      prospectively together with several centers once the diagnostic criteria are set in order to
      fulfill the statistical needed numbers.

      Significance An early diagnosis of both CCC developing in PSC patients and PDAC developing in
      CP, IPMN patients or individuals with familiar history of PDAC would allow us to treat these
      patients in good time with surgery or transplantation (LTX). This, in turn, is the only way
      to improve the diagnosis of these tumors as the have amongst the worst prognosis of all solid
      tumors in man.
    

Intervention name(s): Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy
Intervention type(s): Procedure
Intervention description(s): The intervention consists of mother-baby endoscopy of the bile and/or pancreatic duct with visual inspection, confocal laser microscopy, collection of fluid for cytology, and eventually biopsy.
Other intervention name(s): Spyglass; Cellvizio; pCLE
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PSC; mother-baby endoscopy; ERCP; IPMN