Gallbladder Stenting in FC-SEMS

Not Applicable

Not yet recruiting

• Conditions: Biliary Obstruction; Acute Cholecystitis

• Registration Number: NCT06820541
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-03-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Technical success	1 mont	The rate of transpapillary gallbladder drainage, defined as the percentage of complete placement of the stent, will be calculated

Trial Locations

Locations (1)

AOUI Verona; 🇮🇹 Verona, Italy