Diagnosis and Percutaneous Treatment of Biliary Tract Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
This study aims to implement and optimize the treatment of bile duct diseases in participants not eligible for endoscopic treatment using the Spyglass system, a system suitable for diagnostic and therapeutic endoscopic procedures in the pancreatic-biliary system, including the hepatic ducts.
The main question it aims to answer is:
\- Can the percutaneous cholangioscopic assisted technique resolve the biliary litiasis and/or perform endobiliary biopsies in less time than the traditional technique?
Participants will undergo a colangioscopic-assisted treatment using the SpyGlass mini-endoscopic system at the Addomino-pelvic diagnostic and interventional radiology UOC of the Bologna University Hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Radiological diagnosis of indeterminate gallstones or stenosis of the bile ducts not eligible for endoscopic treatment and/or previous failed endoscopic treatment
Good liver function (hemoglobin, hematocrit, GOT, GPT, GGT within normal ranges)
Age over 18
Obtaining informed consent
Disqualifiers
presence of severe untreatable coagulopathies
Trial design
Design model
Single group
Treatments tested in this trial
Percutaneous cholangioscopic-assisted treatment
Procedure/SurgeryThe intervention administered is a percutaneous colangioscopic assisted technique that uses endoscopic Spyglass system. The endoscopic Spyglass system is designed to provide direct viewing and to guide both optical devices and accessories for lithotripsy in case of litiasic pathology and is equipped with a suitable bioptic clamp in case of biopsy collection. The use of the digital Spyglass catheter involves the preliminary percutaneous puncture of the bile ducts with a right, left or combined approach, and the subsequent execution of a cholangiographic study. Additional treatment sessions may be performed every 15-20 days in case of residual lithiasis. At the end of each session, an internal-external transeptic percutaneous drainage (ptbd) of adequate caliber (8-14 fr) is left in place to monitor any complications and maintain a route of access for sequential treatments.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Patients with bile duct disease not eligible for endoscopic treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of treatments
Number of treatments
Time frame
From enrollment to the end of treatment at 7 years2
Duration of drainage
Duration of drainage
Time frame
From enrollment to the end of treatment at 7 years3
Relapse free interval
Relapse free interval
Time frame
From enrollment to the end of treatment at 7 years4
Duration of hospitalization
Duration of hospitalization
Time frame
From enrollment to the end of treatment at 7 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov