Diagnosis and Percutaneous Treatment of Biliary Tract Diseases

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Alberta Cappelli, MD
alberta.cappelli@aosp.bo.it
+39 051 6362598
Time Frame
Start Date: 2022-10-14
Estimated Completion Date: 2027-01
Participants
Target number of participants: 24
Treatments
Experimental: Patients with bile duct disease not eligible for endoscopic treatment
Before the procedure all patients will be submitted to US and/or CT and/or MRI and will be evaluated for hemoglobin, hematocrit and liver function tests. Patients with biliary tract disorders that are not eligible for endoscopic treatment and/or previous failed endoscopic treatment will be evaluated for inclusion in this study. Therefore, a case-by-case discussion will be conducted with the reference hepatologists/surgeons to assess treatment assignment. Once enrolled in the study, patients will undergo cholangioscopic-assisted treatment at the UOC addomino-pelvic diagnostic and interventional radiology unit of the Bologna University Hospital. After the procedure, patients will be required to perform a clinical laboratory monitoring in subsequent follow-up controls that will be performed 3-6-12-24-36 months after treatment. Additional imaging examinations (US, CT or MRI) will only be scheduled if symptoms recur.
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov