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

Benign Neoplasm of Liver and/or Biliary Ducts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057146
• Other study ID #: 2013/1658-31
• Secondary ID: 2013/1658-31
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: August 22, 2019

Study information

• Verified date: October 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 22, 2019
• Est. primary completion date: August 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Suspicious lesions of the hepatobiliary pancreatic duct systems.

Exclusion Criteria:

• Unwillingness to participate

• Unfit for the investigation

Related Conditions & MeSH terms

• Benign Neoplasm of Liver and/or Biliary Ducts
• Benign Neoplasms of the Pancreas
• Brain Neoplasms
• Liver Neoplasms
• Neoplasm of Uncertain Behavior of Biliary System
• Neoplasms
• Neoplasms of the Pancreas
• Pancreatic Neoplasms
• Precancerous Conditions

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Arnelo U, Albiin N, Enochsson L, Meisner S, Permert J, Lundell L. Endoscopic evaluation of the pancreatic duct system: opportunities offered by novel technology. Scand J Gastroenterol. 2007 Aug;42(8):1018-20. doi: 10.1080/00365520601101526. — View Citation

Arnelo U, Valente R, Scandavini CM, Halimi A, Mucelli RMP, Rangelova E, Svensson J, Schulick RD, Torphy RJ, Fagerstrom N, Moro CF, Vujasinovic M, Matthias Lohr J, Del Chiaro M. Intraoperative pancreatoscopy can improve the detection of skip lesions during — View Citation

Lohr JM, Lonnebro R, Stigliano S, Haas SL, Swahn F, Enochsson L, Noel R, Segersvard R, Del Chiaro M, Verbeke CS, Arnelo U. Outcome of probe-based confocal laser endomicroscopy (pCLE) during endoscopic retrograde cholangiopancreatography: A single-center p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of single operator endoscopy plus pCLE in the biliary and pancreatic ductal system diagnosing premalignant and malignant lesions.	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