Gallbladder Stenting in FC-SEMS

NCT ID: NCT06820541

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-10-01

Brief Summary

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

Conditions

Biliary Obstruction; Acute Cholecystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Transpapillary stenting

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Standard biliary drainage

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

Group Type: ACTIVE_COMPARATOR

Fully covered self-expandable metal stent

Intervention Type: DEVICE

After biliary cannulation, a fully covered self-expandable metal stent will be placed for biliary drainage

Interventions

Double plastic pigtail stent plus 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.

Intervention Type: DEVICE

Fully covered self-expandable metal stent

After biliary cannulation, a fully covered self-expandable metal stent will be placed for biliary drainage

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AOUI Verona

Verona, , Italy

Countries

Italy

Central Contacts

Stefano Francesco Crinò, MD, PhD

Role: CONTACT

stefanofrancesco.crino@aovr.veneto.it

00390458126191

Facility Contacts

Stefano Francesco Crinò, MD, PhD

Role: primary

stefanofrancesco.crino@aovr.veneto.it

00390458126191

Other Identifiers

GB-COVER

Identifier Type: -

Identifier Source: org_study_id