Cholecystectomy vs EUS-guided GBD With Stone Removal

Launched by INSTITUTO ECUATORIANO DE ENFERMEDADES DIGESTIVAS · Sep 7, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two different treatments for patients with gallstones, a condition known as cholelithiasis. The traditional approach is a surgery called laparoscopic cholecystectomy, which involves removing the gallbladder. However, researchers are exploring a newer, less invasive method called endoscopic ultrasound-guided gallbladder drainage (EUS-guided GBD) combined with stone removal. This trial aims to find out if this newer method is safe and effective compared to the standard surgery.

To participate in this study, you need to be an adult between 18 and 89 years old with symptoms of gallstones confirmed by an ultrasound. You should also be a good candidate for either the standard surgery or the new EUS-guided procedure. If you join the trial, you will be monitored closely to see how well the new treatment works and to ensure your safety. It’s important to know that not everyone can participate, especially those with certain medical conditions or complications related to gallstones. If you're interested or have questions, you can discuss it with your healthcare provider for more personalized information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults \>18 years old and \<89 years old
• • Adult symptomatic patients with gallstones documented by US
• • Subject is a suitable candidate for an elective laparoscopic cholecystectomy or an EUS-guided GBD
• • Patients or authorized representative give informed consent for endoscopic or surgical approach
• Exclusion Criteria:
• • Patients with hepato-pancreato-biliary diseases other than gallstones (tumors, obstructions, inflammation)
• • Patients with acute cholecystitis, cholangitis or choledocholithiasis.
• • Patients with gallbladder polyps, family history of gallbladder cancer, or any other high-risk factor for gallbladder cancer
• • Patient unable to give informed consent or refuse to participate.
• • Prior biliary intervention
• • Pregnancy or nursing
• • Any other medical condition that contraindicates surgical or endoscopic procedures