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
Qualifiers
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
Treatments tested in this trial
- Double plastic pigtail stent plus fully covered self-expandable metal stent
- Fully covered self-expandable metal stent
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov