Acute Cholecystitis, Biliary Obstruction
Conditions
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
Interventions
DEVICEDouble 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.
DEVICEFully covered self-expandable metal stent
After biliary cannulation, a fully covered self-expandable metal stent will be placed for biliary drainage
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will be not informed about the treatment received
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute cholecystitis | 6 months | The rate of acute cholecystitis, defined according to the Tokyo guideline, will be calculated and compared between the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall adverse events | 6 months | The overall adverse events rate will be calculated and compared between the two groups |
| Hospitalization | 6 months | The duration of the hospitalization will be calculated and |
| Disease-free survival | 6 months | Acute cholecystitis free-survival rate, calculated as days from endoscopic retrograde cholangiopancreatography to acute cholecystitis or end of follow-up, cholecystectomy, or death, will be calculated and compared between the two groups |
| Technical success | 1 mont | The rate of transpapillary gallbladder drainage, defined as the percentage of complete placement of the stent, will be calculated |
| Procedure time | 1 month | The time of the procedure, calculates ad minutes starting after randomization to the end of the procedure, will be calculated and compared between the teo groups |
Countries
Italy
Contacts
Primary ContactStefano Francesco Crinò, MD, PhD
Outcome results
None listed