Gallbladder Stenting in FC-SEMS

Launched by AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a procedure called transpapillary gallbladder drainage can help prevent a condition known as acute cholecystitis in patients who are at higher risk after having a special type of stent placed in their bile duct. Acute cholecystitis is an inflammation of the gallbladder that can occur after a procedure called endoscopic retrograde cholangiopancreatography (ERCP), which is used to treat blockages in the bile duct caused by cancer. Researchers want to see if adding this drainage procedure reduces the chances of developing acute cholecystitis in patients who have certain risk factors, such as specific findings on imaging tests or the presence of gallstones.

To be eligible for this study, participants need to be adults who have signed consent and require a covered metal stent to manage their bile duct blockage. They should also be identified as high-risk for acute cholecystitis based on imaging results or other medical criteria. During the trial, participants will either receive the gallbladder drainage procedure or not before their stent placement. They will be monitored for one, three, and six months afterward to check if they develop acute cholecystitis. It's important to note that this trial is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 1. gallbladder stones;
• • 2. CBD diameter ≤ 10 mm;
• • 3. intraprocedural gallbladder opacification;
• • 4. cystic duct orifice at risk of being covered by the fully-covered stent
• Exclusion Criteria:
• • 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