Diagnosis and Percutaneous Treatment of Biliary Tract Diseases

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Gallstone; Biliary Diseases; Biliary Stricture

Treatments: Procedure: Percutaneous cholangioscopic-assisted treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06816615

SPY2021

Details and patient eligibility

About

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.

Full description

This is a pilot, spontaneous, non-pharmacological, prospective and single-center interventional study aimed at participants with bile duct diseases not eligible for endoscopic treatment, who, once enrolled, will undergo percutaneous colangioscopic-assisted treatment at the Addominal-pelvic diagnostic and interventional radiology UOC of the University Hospital of Bologna. After a 24-month enrollment phase, a 36-month follow-up phase will be undertaken to assess the functional and therapeutic outcomes of this approach.

The enrollment and the collection of informed consent will be carried out by the Radiologists involved in the study who will also take care of the collection of clinical data and the review of all pseudoanymous radiological images pre/post treatment in order to evaluate the outcome of percutaneous treatment, the number of treatments, the duration of drainage stay, the relapse-free interval and the length of hospitalization. Participants in the study will undergo treatments commonly used in daily clinical practice, including biliary clearance and/or endobiliary biopsy.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• presence of severe untreatable coagulopathies

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Patients with bile duct disease not eligible for endoscopic treatment

Experimental group

Description:

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.

Treatment:

Procedure: Percutaneous cholangioscopic-assisted treatment