Comparing endoscopic and non-endoscopic treatments for inoperable acute cholecystitis
Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Patients With Inoperable Acute Cholecystitis: a Multicenter Randomized Clinical Trial (EUS-DRAIN)
This study is testing whether a new endoscopic treatment for gallbladder issues works better than just using antibiotics for patients who can't have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Fundacion Miguel Servet Academic / other |
| Locations | 1 site (Pamplona, Navarre) |
| Trial ID | NCT05702775 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) versus non-endoscopic treatment with antibiotics in patients diagnosed with inoperable acute lithiasic cholecystitis. The study will randomly assign participants to either treatment group and assess outcomes such as the rate of subsequent endoscopic procedures, recurrence of acute cholecystitis, and quality of life. Additionally, the trial will evaluate the costs associated with each treatment approach to provide comprehensive insights for healthcare professionals. The hypothesis is that EUS-GBD will lead to fewer subsequent procedures compared to antibiotic treatment alone.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a definitive diagnosis of acute lithiasic cholecystitis who are deemed inoperable.
Not a fit: Patients with operable acute cholecystitis or those who refuse to participate in the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with inoperable acute cholecystitis, potentially reducing complications and improving quality of life.
How similar studies have performed: Other studies have shown promising results with endoscopic treatments for similar conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pamplona, Navarre
- Hospital Universitario de Navarra — Pamplona, Navarre, Spain (Recruiting)
Study contacts
- Study coordinator: Jesús JU Urmán, PhD
- Email: jmurmanf@gmail.com
- Phone: +(34) 8484422222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.