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NCT Number: NCT06820541

Gallbladder Stenting in FC-SEMS

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

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Key information

Conditions

Biliary Obstruction Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Fully covered self-expandable metal stent

Device

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

Primary outcomes

  1. Acute cholecystitis

    Time frame: 6 months

    The rate of acute cholecystitis, defined according to the Tokyo guideline, will be calculated and compared between the two groups

Secondary outcomes

  1. Overall adverse events

    Time frame: 6 months

    The overall adverse events rate will be calculated and compared between the two groups

  2. Hospitalization

    Time frame: 6 months

    The duration of the hospitalization will be calculated and

  3. Disease-free survival

    Time frame: 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

  4. Technical success

    Time frame: 1 mont

    The rate of transpapillary gallbladder drainage, defined as the percentage of complete placement of the stent, will be calculated

  5. Procedure time

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Francesco Crinò, MD, PhD

CONTACT

[email protected]

00390458126191

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

Prophylactic Endoscopic Transpapillary Gallbladder Drainage to Prevent Post-ERCP Cholecystitis After Covered Metal Stent Placement for Distal Biliary Obstruction: a Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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