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NCT Number: NCT00930410

Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor

The endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.

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Key information

Conditions

Pancreas Neoplasms Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut PAOLI-CALMETTES, Marseille, France

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About this study

Primary objective:

Obtain a tissular characterization of a biliary or pancreatic stenosis with a confocal microscope which is in direct contact of the stenosis during the Endoscopic Retrograde Cholangio-Pancreatography (ERCP).

Secondary objectives:

  • Compare the result of this "optical biopsy" to a conventional biopsy.
  • Tolerance

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged from 18 to older
  • Patient with an inflammatory or tumoral stenosis of bile duct or a solid or cystic tumor in the pancreas with a dilatation of the principal pancreatic canal.
  • Signed consent

Non inclusion Criteria:

  • Patient who have no indication for an ERCP
  • Allergy to fluorescein
  • Allergic rhinitis, asthma, eczema
  • Pregnancy, breast feeding
  • Patients with dialysis
  • Patient with severe heart failure
  • Patient with cirrhosis
  • Hemostasis failure which can induce difficulties or contraindication for the biopsy during the conventional endoscopy

Treatment and study plan

Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Procedure

Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.

Primary outcomes

  1. The principal outcome is the percentage of successful in vivo examination according to the localisation of the stenosis. A successful examination is defined by the obtention of exploitable image for the anatomopathology.

    Time frame: 2 days

Secondary outcomes

  1. Study of the concordance between optical and histological biopsy

    Time frame: 2 days

  2. Frequency and grade of adverse effects induced by the confocal endomicroscopy

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: EMID

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2009
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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