Gallbladder Stenting in FC-SEMS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Double plastic pigtail stent plus fully covered self-expandable metal stent, Fully covered self-expandable metal stent.
- Who it may be relevant to
- Registry conditions: Biliary Obstruction, Acute Cholecystitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prophylactic Endoscopic Transpapillary Gallbladder Drainage to Prevent Post-ERCP Cholecystitis After Covered Metal Stent Placement for Distal Biliary Obstruction: a Randomized Controlled Study
Overview
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
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 met - Device Fully covered self-expandable metal stent
After biliary cannulation, a fully covered self-expandable metal stent will be placed for biliary drainage
Primary outcome measures
- Acute cholecystitis [Time frame: 6 months]
Secondary outcome measures (5)
- Overall adverse events [Time frame: 6 months]
- Hospitalization [Time frame: 6 months]
- Disease-free survival [Time frame: 6 months]
- Technical success [Time frame: 1 mont]
- Procedure time [Time frame: 1 month]
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:
- gallbladder stones;
- CBD diameter ≤ 10 mm;
- intraprocedural gallbladder opacification;
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Italy · 1 center
- AOUI Verona — Verona
Identifiers
NCT: NCT06820541 · GB-COVER