Clinical trial NCT06816615: Diagnosis and Percutaneous Treatment of Biliary Tract Diseases
Official title: Diagnosis and Percutaneous Treatment of Biliary Tract Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gallstone
Biliary Stricture
Biliary Diseases
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of treatments
timeFrame: From enrollment to the end of treatment at 7 years
measure: Duration of drainage
timeFrame: From enrollment to the end of treatment at 7 years
measure: Relapse free interval
timeFrame: From enrollment to the end of treatment at 7 years
measure: Duration of hospitalization
timeFrame: From enrollment to the end of treatment at 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Alberta Cappelli, MD
role: PRINCIPAL_INVESTIGATOR
References: