Biliary ObstructionNCT06820541
Gallbladder Stenting in FC-SEMS
A study testing Double plastic pigtail stent plus fully covered self-expandable metal stent and Fully covered self-expandable metal stent in people with Biliary Obstruction and Acute Cholecystitis, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction, Acute Cholecystitis
- What is being tested?
- Double plastic pigtail stent plus fully covered self-expandable metal stent and Fully covered self-expandable metal stent
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to 1 Oct 2026
- 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
- Adult patients
- Signed informed consent
- Patients requiring covered metal stent placement for managing MBO
- High-risk of post-endoscopic cholangiopancreatography acute cholecystitis according to the following criteria:
- tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;
- presence of at least 2 of the following:
Show all 10Show fewer
- gallbladder stones;
- CBD diameter ≤ 10 mm;
- intraprocedural gallbladder opacification;
- cystic duct orifice at risk of being covered by the fully-covered stent
Who cannot join
- History of cholecystectomy
- Endoscopic retrograde cholangiopancreatography not feasible for duodenal stenosis or failed biliary cannulation
- Patients with previous gallbladder drainage
- Acute cholecystitis is already present based on the Tokyo guidelines
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
AOUI Verona
Verona, 37134
Stefano Francesco Crinò, MD, PhD, 00390458126191, stefanofrancesco.crino@aovr.veneto.it
About this study
Official title: Prophylactic Endoscopic Transpapillary Gallbladder Drainage to Prevent Post-ERCP Cholecystitis After Covered Metal Stent Placement for Distal Biliary Obstruction: a Randomized Controlled Study
The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis.
The main question it aims to answer is:
Read more
Does prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis.
Participants will:
- receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement
- will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis
- Conditions
- Biliary Obstruction, Acute Cholecystitis
- Being tested
- Double plastic pigtail stent plus fully covered self-expandable metal stent, Fully covered self-expandable metal stent
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double plastic pigtail stent plus fully covered self-expandable metal stentDevice
After contrast injection, the cystic duct orifice will be detected. Using a sphincterotome, a 0.035-inch hydrophilic angled guidewire will be negotiated into the gallbladder. Dilation of the cystic duct will be performed using standard devices designed for biliary intervention, including pneumatic dilators or dilation progressive catheters. After dilation, a 7Fr plastic, double pigtail stent, length of 12 or 15 cm, will be deployed across the papilla. Finally, a fully-covered self-expandable metal stent will be placed alongside the gallbladder drainage for biliary drainage.
Fully covered self-expandable metal stentDevice
After biliary cannulation, a fully covered self-expandable metal stent will be placed for biliary drainage
| Study group | Role | What they receive |
|---|---|---|
| Transpapillary stenting | Experimental | Patients will undergo prophylactic transpapillary gallbladder drainage followed by fully-covered self-expandable metal stent placement for biliary drainage Receives: Device: Double plastic pigtail stent plus fully covered self-expandable metal stent |
| Standard biliary drainage | Active comparator | Patients will undergo fully-covered self-expandable metal stent placement for biliary drainage Receives: Device: Fully covered self-expandable metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute cholecystitis
The rate of acute cholecystitis, defined according to the Tokyo guideline, will be calculated and compared between the two groups
Measured: 6 months
Secondary outcomes (5)
Overall adverse events
The overall adverse events rate will be calculated and compared between the two groups
Measured: 6 months
Hospitalization
The duration of the hospitalization will be calculated and
Measured: 6 months
Disease-free survival
Acute cholecystitis free-survival rate, calculated as days from endoscopic retrograde cholangiopancreatography to acute cholecystitis or end of follow-up, cholecystectomy, or death, will be calculated and compared between the two groups
Measured: 6 months
Technical success
The rate of transpapillary gallbladder drainage, defined as the percentage of complete placement of the stent, will be calculated
Measured: 1 mont
Procedure time
The time of the procedure, calculates ad minutes starting after randomization to the end of the procedure, will be calculated and compared between the teo groups
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary ObstructionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820541
- Sponsor's protocol ID
- GB-COVER
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Endoscopic Transpapillary Gallbladder Drainage to Prevent Post-ERCP Cholecystitis After Covered Metal Stent Placement for Distal Biliary Obstruction: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06820541
- Acronym / sponsor ID
- GB-COVER
- Conditions
- Biliary Obstruction, Acute Cholecystitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 11 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.
The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis.
The main question it aims to answer is:
Does prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis.
Participants will:
- receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement
- will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transpapillary stenting | Experimental | Device: Double plastic pigtail stent plus fully covered self-expandable metal stentPatients will undergo prophylactic transpapillary gallbladder drainage followed by fully-covered self-expandable metal stent placement for biliary drainage |
| Standard biliary drainage | Active comparator | Device: Fully covered self-expandable metal stentPatients will undergo fully-covered self-expandable metal stent placement for biliary drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patients
- Signed informed consent
- Patients requiring covered metal stent placement for managing MBO
- High-risk of post-endoscopic cholangiopancreatography acute cholecystitis according to the following criteria:
- tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;
Key exclusion criteria (4 listed)
- History of cholecystectomy
- Endoscopic retrograde cholangiopancreatography not feasible for duodenal stenosis or failed biliary cannulation
- Patients with previous gallbladder drainage
- Acute cholecystitis is already present based on the Tokyo guidelines
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 |
|---|---|---|
| Double plastic pigtail stent plus fully covered self-expandable metal stentAfter contrast injection, the cystic duct orifice will be detected. Using a sphincterotome, a 0.035-inch hydrophilic angled guidewire will be negotiated into the gallbladder. Dilation of the cystic duct will be performed using standard devices designed for biliary intervention, including pneumatic dilators or dilation progressive catheters. After dilation, a 7Fr plastic, double pigtail stent, length of 12 or 15 cm, will be deployed across the papilla. Finally, a fully-covered self-expandable metal stent will be placed alongside the gallbladder drainage for biliary drainage. | Device | Transpapillary stenting |
| Fully covered self-expandable metal stentAfter biliary cannulation, a fully covered self-expandable metal stent will be placed for biliary drainage | Device | Standard biliary drainage |
Primary outcome
Acute cholecystitis
Time frame: 6 months
The rate of acute cholecystitis, defined according to the Tokyo guideline, will be calculated and compared between the two groups
5 secondary outcomes
Overall adverse events
Time frame: 6 months
Hospitalization
Time frame: 6 months
Disease-free survival
Time frame: 6 months
Technical success
Time frame: 1 mont
Procedure time
Time frame: 1 month
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 11 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double plastic pigtail stent plus fully covered self-expandable metal stent and Fully covered self-expandable metal stent in people with Biliary Obstruction and Acute Cholecystitis, run by Azienda Ospedaliera Universitaria Integrata Verona 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 10 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 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 Stefano Francesco Crinò, MD, PhD (00390458126191, stefanofrancesco.crino@aovr.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute cholecystitis (time frame: 6 months). 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 11 Feb 2025.