Needle-based Confocal Laser Endomicroscopy on Pancreatic Cystic Lesions

Summary

The study is based on a multi-center approach of needle based confocal laser endomicroscopy (nCLE) combined with endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (FNA) to evaluate pancreatic cystic lesions (PCL), in order to obtain a correct histopathological diagnosis.After detection of PCL, certain morphological EUS features allow the discrimination of specific cyst types. Additionally, EUS-FNA is recommended as the first-line procedure whenever pathological diagnosis is required; however the procedure has its drawbacks, mainly represented by the relatively low negative predictive value in diagnosing pancreatic cancer. In this case a more precisely diagnostic tool is required; the potential role of CLE has been explored in gastrointestinal (GI) pathology showing good accuracy for predicting the final histopathological diagnosis based on immediate evaluation of tissue and vascular patterns. Although the clinical impact of nCLE for the decision making algorithms in cystic pancreatic neoplasm has not yet been described, the hypothesis is that EUS-nCLE could allow targeted tissue sampling of cystic pancreatic neoplasms resulting in more accurate diagnosis. The aim of the study is to describe the clinical impact of nCLE for the clinical decision management algorithm based on EUS, EUS-FNA and/or EUS-CLE imaging criteria for cystic pancreatic neoplasms, while evaluating also the feasibility and safety of nCLE examination.

Conditions

• Pancreatic Cysts
• Pancreatic Mucinous-Cystic Neoplasm
• Intraductal Papillary Mucinous Neoplasm
• Solid Pseudopapillary Tumour of the Pancreas
• Cystadenocarcinoma
• Serous Cystadenoma

Interventions

PROCEDURE

Endoscopic ultrasound guided needle based confocal endomicroscopy

Needle based confocal laser endomicroscopy is a technique that enables in vivo microscopic analysis during ongoing endoscopy. It has good accuracy for predicting the final histopathological diagnosis based on immediate evaluation of tissue and vascular patterns. nCLE microprobe is a flexible probe thin enough that it can be passed through a 19-gauge needle. Thus under EUS guidance solid organs (i.e. the pancreas) can be accessed for real-time microscopic information.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Ochsner Health System

  collaborator OTHER

• Jefferson Medical College of Thomas Jefferson University

  collaborator OTHER

• New York Presbyterian Hospital

  collaborator OTHER

• University of Medicine and Pharmacy Craiova

  lead OTHER

Principal Investigators

• Peter Vilmann · Copenhagen University Hospital at Herlev

• Stephen Pereira · University College London Hospitals

• Bill Brugge · Massachusetts General Hospital

• Manoop Bhutani · The University of Texas MD Anderson Cancer Center

• Virendra Joshi · Ochsner Health System

• Ali Siddiqui · Jefferson Medical College of Thomas Jefferson University

• Reem Sharaiha · New York Presbyterian Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2017-06-30

Completion

2017-06-30

Countries

• United States
• Denmark
• Romania
• United Kingdom

Study Locations