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Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases

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ClinicalTrials.gov Identifier: NCT03190343
Recruitment Status : Active, not recruiting
First Posted : June 16, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Arthur Laquiere, Hospital St. Joseph, Marseille, France

Study Description
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Brief Summary:

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 However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PATIENTS WITH BILIARY OR PANCREATIC DUCT STENOSIS
Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 years
  • Patients with biliary duct stenosis with undetermined etiology
  • Patients with pancreatic duct stenosis with undetermined etiology
  • Patients with pancreatic duct distension with undetermined etiology
  • Patients with biliary or pancreatic gallstones after failure to endoscopic treatment

Exclusion Criteria:

  • Patients with haemorrhagic disease or hemostasis and coagulation disorders (TP < 60%, TCA> 40 sec. and platelets < 60000/mm3).
  • Patients treated with anticoagulant or platelet aggregation inhibiting drugs that could not be temporarily interrupted.
  • Patients with biliary duct diameter < 3 mm
  • Patients with pancreatic duct diameter <3 mm
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
Hopital Mermoz
Lyon, France, 69008
Hopital Saint Joseph
Marseille, France, 13008
Centre Hospitalier Jacques Lacarin
Vichy, France, 03200
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
Investigators
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Principal Investigator: ARTHUR LAQUIERE, MD French Society of Digestive Endoscopy
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Arthur Laquiere, Gastroenterologist, Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT03190343     History of Changes
Other Study ID Numbers: CCTIRS 16-351
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Pancreatic Diseases
Biliary Tract Diseases
Bile Duct Diseases
Common Bile Duct Diseases
Digestive System Diseases