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

October 22, 2023 updated by: Matthias Löhr, Karolinska University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Suspicious lesions of the hepatobiliary pancreatic duct systems.

Exclusion Criteria:

  • Unwillingness to participate
  • Unfit for the investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Cellvizio
  • pCLE
  • Spyglass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Matthias Löhr, Professor, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

August 22, 2019

Study Completion (Actual)

August 22, 2019

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimated)

February 6, 2014

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/1658-31 (Other Identifier: Ethical Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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