Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis

Launched by FUNDACION MIGUEL SERVET · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to treat patients with acute cholecystitis, which is a severe inflammation of the gallbladder that can happen when gallstones block the bile duct. The researchers want to compare traditional treatment with antibiotics to a newer method called endoscopic ultrasound-guided gallbladder drainage (EUS-GBD). They hope that the endoscopic treatment will lead to fewer complications and better overall health outcomes for patients who cannot undergo surgery due to various health issues.

To participate in this trial, patients need to be over 18 years old and diagnosed with acute cholecystitis, with the determination that surgery is not an option—this might be due to age, existing health conditions, or personal choice. Participants will receive either the antibiotic treatment or the endoscopic drainage, and the study will track how well each method works, including any recurrences of cholecystitis and impacts on quality of life. This research aims to provide valuable information to help doctors choose the best treatment for patients with this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient older than 18 years.
• • Definitive diagnosis of acute lithiasic cholecystitis according to the GP Tokyo 2018 criteria.
• • Surgical decision of inoperable patient (if one or more of the following criteria is met: age ≥80 years, American Society of Anesthesiology (ASA) III or more, Charlson Comorbidity Index \> 5 and/or Karnofsky \< 50 or decision of the patient not to have surgery.
• • Signature of the informed consent of the study
• Exclusion Criteria:
• • Operable acute cholecystitis.
• • Refusal of the patient to participate in the study.
• • Anatomy of the GI tract altered by previous hepatobiliary or upper GI surgery.
• • Ascites.
• • Inability to tolerate endoscopy sedation, perforation of the digestive tract, or other contraindication to endoscopy.
• • Patients with decompensated cirrhosis, portal hypertension and/or gastric varices
• • Coagulopathy with uncorrectable INR\>1.5 or thrombocytopenia \<50,000/mm3 uncorrectable.
• • Other diagnoses on admission (choledocholithiasis, liver abscesses, acute pancreatitis or biliopancreatic neoplasia).
• • Hemodynamic instability.
• • Baseline ECOG \>=4
• • Survival expectancy \< 6 months