NCT00930410

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

3.7 years

First QC Date

June 27, 2009

Last Update Submit

March 19, 2013

Conditions

Pancreas NeoplasmsBile Duct Diseases

Keywords

pancreas neoplasmsbile duct diseasesCholangiopancreatography, Endoscopic RetrogradeERCP

Outcome Measures

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.

    2 days

Secondary Outcomes (2)

  • Study of the concordance between optical and histological biopsy

    2 days

  • Frequency and grade of adverse effects induced by the confocal endomicroscopy

    2 days

Study Arms (1)

endomicroscopy

EXPERIMENTAL

Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography

Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Interventions

Endoscopic Retrograde Cholangio-Pancreatography (ERCP)PROCEDURE

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

endomicroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut PAOLI-CALMETTES

Marseille, France

Location

Centre Hospitalier Princesse Grasse

Monaco, Monaco

Location

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsBile Duct Diseases

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract Diseases

Study Officials

  • Marc GIOVANNINI, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2009

First Posted

June 30, 2009

Study Start

September 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 20, 2013

Record last verified: 2013-03

Locations

MO(1)FR(1)