GallstoneNCT06816615
Diagnosis and Percutaneous Treatment of Biliary Tract Diseases
A study testing Percutaneous cholangioscopic-assisted treatment in people with Gallstone and Biliary Stricture, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone, Biliary Stricture, Biliary Diseases
- What is being tested?
- Percutaneous cholangioscopic-assisted treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- presence of severe untreatable coagulopathies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40138
Alberta Cappelli, MD, +39 051 6362598, alberta.cappelli@aosp.bo.it
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Gallstone, Biliary Stricture, Biliary Diseases
- Being tested
- Percutaneous cholangioscopic-assisted treatment
- Medical subject headings
- Gallstones, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous cholangioscopic-assisted treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bile duct disease not eligible for endoscopic treatment | Experimental | 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. Receives: Procedure: Percutaneous cholangioscopic-assisted treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatments
Number of treatments
Measured: From enrollment to the end of treatment at 7 years
Duration of drainage
Duration of drainage
Measured: From enrollment to the end of treatment at 7 years
Relapse free interval
Relapse free interval
Measured: From enrollment to the end of treatment at 7 years
Duration of hospitalization
Duration of hospitalization
Measured: From enrollment to the end of treatment at 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start14 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstoneStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberta Cappelli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816615
- Sponsor's protocol ID
- SPY2021
- Status last verified
- Nov 2024
- First submitted
- 9 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Percutaneous Treatment of Biliary Tract Diseases
- ClinicalTrials.gov ID
- NCT06816615
- Acronym / sponsor ID
- SPY2021
- Conditions
- Gallstone, Biliary Stricture, Biliary Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bile duct disease not eligible for endoscopic treatment | Experimental | Procedure: Percutaneous cholangioscopic-assisted treatmentBefore 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- presence of severe untreatable coagulopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous cholangioscopic-assisted treatmentThe 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. | Procedure or surgery | Patients with bile duct disease not eligible for endoscopic treatment |
Primary outcome
Number of treatments
Time frame: From enrollment to the end of treatment at 7 years
Number of treatments
Duration of drainage
Time frame: From enrollment to the end of treatment at 7 years
Duration of drainage
Relapse free interval
Time frame: From enrollment to the end of treatment at 7 years
Relapse free interval
Duration of hospitalization
Time frame: From enrollment to the end of treatment at 7 years
Duration of hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alberta Cappelli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous cholangioscopic-assisted treatment in people with Gallstone and Biliary Stricture, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberta Cappelli, MD (+39 051 6362598, alberta.cappelli@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatments (time frame: From enrollment to the end of treatment at 7 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.