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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 : Unknown
Verified April 2019 by Arthur Laquiere, Hospital St. Joseph, Marseille, France.
Recruitment status was:  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

Tracking Information
First Submitted Date June 14, 2017
First Posted Date June 16, 2017
Last Update Posted Date April 4, 2019
Actual Study Start Date November 2016
Actual Primary Completion Date January 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2017)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases
Official Title Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases Trial " EASYSPY "
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 However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population PATIENTS WITH BILIARY OR PANCREATIC DUCT STENOSIS
Condition
  • Lesions of Biliary or Wirsung Ducts
  • Biliary Tract Diseases
  • Common Bile Duct Diseases
  • Pancreatic Duct Disorder
Intervention Procedure: cholangio-pancreatoscopy
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: April 3, 2019)
67
Original Estimated Enrollment
 (submitted: June 14, 2017)
60
Estimated Study Completion Date January 2020
Actual Primary Completion Date January 28, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03190343
Other Study ID Numbers CCTIRS 16-351
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Arthur Laquiere, Hospital St. Joseph, Marseille, France
Study Sponsor Hospital St. Joseph, Marseille, France
Collaborators Not Provided
Investigators
Principal Investigator: ARTHUR LAQUIERE, MD French Society of Digestive Endoscopy
PRS Account Hospital St. Joseph, Marseille, France
Verification Date April 2019