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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endomicroscopy | Experimental | Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Retrograde Cholangio-Pancreatography (ERCP) | Procedure | Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Study of the concordance between optical and histological biopsy | 2 days | |
| Frequency and grade of adverse effects induced by the confocal endomicroscopy | 2 days |
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Inclusion Criteria:
Non inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc GIOVANNINI, MD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut PAOLI-CALMETTES | Marseille | France | ||||
| Centre Hospitalier Princesse Grasse |
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| Label | URL |
|---|---|
| Official web site of the sponsor | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001649 | Bile Duct Diseases |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Monaco |
| Monaco |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |