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NCT Number: NCT06816615

Diagnosis and Percutaneous Treatment of Biliary Tract Diseases

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.

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Key information

Conditions

Gallstone Biliary Diseases Biliary Stricture Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

Location status: Recruiting

Location contact

Alberta Cappelli, MD

CONTACT

[email protected]

+39 051 6362598

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous cholangioscopic-assisted treatment

Procedure

The 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.

Primary outcomes

  1. Number of treatments

    Time frame: From enrollment to the end of treatment at 7 years

    Number of treatments

  2. Duration of drainage

    Time frame: From enrollment to the end of treatment at 7 years

    Duration of drainage

  3. Relapse free interval

    Time frame: From enrollment to the end of treatment at 7 years

    Relapse free interval

  4. Duration of hospitalization

    Time frame: From enrollment to the end of treatment at 7 years

    Duration of hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Alberta Cappelli, MD

CONTACT

[email protected]

+39 051 6362598

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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