Gallbladder Stenting in FC-SEMS

Integrated University Hospital Trust of Verona

Status: Not yet enrolling

Conditions: Biliary Obstruction; Acute Cholecystitis

Treatments: Device: Fully covered self-expandable metal stent; Device: Double plastic pigtail stent plus fully covered self-expandable metal stent

Study type: Interventional

Funder types: Other

Identifiers

NCT06820541

GB-COVER

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Transpapillary stenting

Experimental group

Description:

Patients will undergo prophylactic transpapillary gallbladder drainage followed by fully-covered self-expandable metal stent placement for biliary drainage

Treatment:

Device: Double plastic pigtail stent plus fully covered self-expandable metal stent

Standard biliary drainage

Active Comparator group

Description:

Patients will undergo fully-covered self-expandable metal stent placement for biliary drainage

Treatment:

Device: Fully covered self-expandable metal stent