Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03190343|
Recruitment Status : Active, not recruiting
First Posted : June 16, 2017
Last Update Posted : April 4, 2019
The biliary and pancreatic tumors are rare but the prognosis is pejorative. It was difficult to have histology of these tumors as the samples taken during ERCP were performed under " blind " radiology control. So the diagnostic accuracy was insufficient.
The arrival of A new optic fiber endoscope used by only one operator had improved the diagnostic of bilio-pancreatic diseases. However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.
A new generation of endoscopes with digital vision appeared and would allow an increase in diagnostic accuracy related to better vision and manoeuvrability.
The purpose of the study is to assess the interest of the cholangio pancreatoscopy performed with digital vision.
|Condition or disease||Intervention/treatment|
|Lesions of Biliary or Wirsung Ducts Biliary Tract Diseases Common Bile Duct Diseases Pancreatic Duct Disorder||Procedure: cholangio-pancreatoscopy|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||67 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases Trial " EASYSPY "|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||January 28, 2019|
|Estimated Study Completion Date :||January 2020|
- Evaluate the diagnostic accuracy of the Spyglass to distinguish a benign lesion from a malignant lesion of the biliary or Wirsung ducts. [ Time Frame: 4 YEARS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190343
|Lyon, France, 69008|
|Hopital Saint Joseph|
|Marseille, France, 13008|
|Centre Hospitalier Jacques Lacarin|
|Vichy, France, 03200|
|Principal Investigator:||ARTHUR LAQUIERE, MD||French Society of Digestive Endoscopy|