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Endoscopic Evaluation of Premalignant Lesions in the Biliary Tract and Pancreatic Ducts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02057146
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : August 28, 2019
Karolinska Institutet
Information provided by (Responsible Party):
Matthias Löhr, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Benign Neoplasm of Liver and/or Biliary Ducts Neoplasm of Uncertain Behavior of Biliary System Benign Neoplasms of the Pancreas Neoplasms of the Pancreas Procedure: Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endoscopic Evaluation of Premalignant Lesions in the Biliary Tract and Pancreatic Ducts
Study Start Date : October 2013
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Mother-baby endoscopy
Spyglass mother-baby endoscopy in conjunction with ERCP
Procedure: Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy
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 Names:
  • Spyglass
  • Cellvizio
  • pCLE

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Suspicious lesions of the hepatobiliary pancreatic duct systems.

Exclusion Criteria:

  • Unwillingness to participate
  • Unfit for the investigation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02057146

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Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
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Principal Investigator: Matthias Löhr, Professor Karolinska University Hospital
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Responsible Party: Matthias Löhr, Professor, Karolinska University Hospital Identifier: NCT02057146    
Other Study ID Numbers: 2013/1658-31
2013/1658-31 ( Other Identifier: Ethical Review Board )
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Matthias Löhr, Karolinska University Hospital:
mother-baby endoscopy
Additional relevant MeSH terms:
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Precancerous Conditions
Brain Neoplasms
Liver Neoplasms
Pancreatic Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases