Clinical trial NCT03190343: 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 "
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lesions of Biliary or Wirsung Ducts
Biliary Tract Diseases
Common Bile Duct Diseases
Pancreatic Duct Disorder
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PATIENTS WITH BILIARY OR PANCREATIC DUCT STENOSIS

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 However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.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.


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

Primary outcomes:
measure: Evaluate the diagnostic accuracy of the Spyglass to distinguish a benign lesion from a malignant lesion of the biliary or Wirsung ducts.
timeFrame: 4 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Mermoz
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Vichy
country: France
facility: Centre Hospitalier Jacques Lacarin
Study officials:
affiliation: French Society of Digestive Endoscopy
name: ARTHUR LAQUIERE, MD
role: PRINCIPAL_INVESTIGATOR
References:
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