Gallbladder Stenting in FC-SEMS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliera Universitaria Integrata Verona
About this trial
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:
1. receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement 2. will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients
Signed informed consent
Patients requiring covered metal stent placement for managing MBO
tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Double plastic pigtail stent plus fully covered self-expandable metal stent
DeviceAfter 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 stent
DeviceAfter biliary cannulation, a fully covered self-expandable metal stent will be placed for biliary drainage
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Transpapillary stentingExperimental treatment 1 intervention
Group B: Standard biliary drainageActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Overall adverse events
The overall adverse events rate will be calculated and compared between the two groups
Time frame
6 months2
Hospitalization
The duration of the hospitalization will be calculated and
Time frame
6 months3
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 months4
Technical success
The rate of transpapillary gallbladder drainage, defined as the percentage of complete placement of the stent, will be calculated
Time frame
1 montSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: