Gallbladder Stenting in FC-SEMS

NCT06820541 | Not Yet Recruiting

• 1 other identifier: GB-COVER
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement
2. 2.will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis

Conditions

Biliary Obstruction; Acute Cholecystitis

Outcome Measures

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

  6 months

Secondary Outcomes (5)

• Overall adverse events

  6 months

• Hospitalization

  6 months

• Disease-free survival

  6 months

• Technical success

  1 mont

• Procedure time

  1 month

Study Arms (2)

Transpapillary stenting

EXPERIMENTAL

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

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

Standard biliary drainage

ACTIVE COMPARATOR

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

Device: Fully covered self-expandable metal stent

Interventions

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

Transpapillary stenting

Fully covered self-expandable metal stent DEVICE

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

Standard biliary drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• gallbladder stones;
• CBD diameter ≤ 10 mm;
• intraprocedural gallbladder opacification;
• cystic duct orifice at risk of being covered by the fully-covered stent

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

AOUI Verona

Verona, 37134, Italy

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Stefano Francesco Crinò, MD, PhD

CONTACT

00390458126191; stefanofrancesco.crino@aovr.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be not informed about the treatment received
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: March 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)