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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03190343
Enrollment
67
Registered
2017-06-16
Start date
2016-11-30
Completion date
2020-01-31
Last updated
2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Diseases, Common Bile Duct Diseases, Lesions of Biliary or Wirsung Ducts, Pancreatic Duct Disorder

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 However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.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

Interventions

PROCEDUREcholangio-pancreatoscopy

Sponsors

Hospital St. Joseph, Marseille, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Evaluate the diagnostic accuracy of the Spyglass to distinguish a benign lesion from a malignant lesion of the biliary or Wirsung ducts.4 YEARS

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026