An interventional study of Double plastic pigtail stent plus fully covered self-expandable metal stent and Fully covered self-expandable metal stent in Biliary Obstruction and Acute Cholecystitis, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Not applicable, Interventional, and Prevention
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:
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's planned enrollment of 80 is below the median of 90 across 84 interventional studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 95 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
presence of at least 2 of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo prophylactic transpapillary gallbladder drainage followed by fully-covered self-expandable metal stent placement for biliary drainage
Device: Double plastic pigtail stent plus fully covered self-expandable metal stent
Patients will undergo fully-covered self-expandable metal stent placement for biliary drainage
Device: Fully covered self-expandable metal stent
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.
After biliary cannulation, a fully covered self-expandable metal stent will be placed for biliary drainage
Acute cholecystitis
The rate of acute cholecystitis, defined according to the Tokyo guideline, will be calculated and compared between the two groups
Time frame: 6 months
Overall adverse events
The overall adverse events rate will be calculated and compared between the two groups
Time frame: 6 months
Hospitalization
The duration of the hospitalization will be calculated and
Time frame: 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
Time frame: 6 months
Technical success
The rate of transpapillary gallbladder drainage, defined as the percentage of complete placement of the stent, will be calculated
Time frame: 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
Time frame: 1 month
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Apr 2026, 13 months later.
Of 42 non-industry interventional studies with no phase under Cholecystitis, Acute, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's planned 13 months is below that.
Counting every sponsor, half of 45 studies reached it within 20 months; a quarter within 9 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliera Universitaria Integrata Verona