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Gallbladder Stenting in FC-SEMS

NCT06820541 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-11

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

Fully covered self-expandable metal stent

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

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-04-01
Completion
2026-10-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06820541 on ClinicalTrials.gov