Actively Recruiting
Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Patients With Inoperable Acute Cholecystitis: a Multicenter Randomized Clinical Trial (EUS-DRAIN)
Led by Fundacion Miguel Servet · Updated on 2023-01-27
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two treatment approaches for patients with inoperable acute lithiasic cholecystitis: non-endoscopic antibiotic treatment versus endoscopic ultrasound-guided gallbladder drainage (EUS-GBD). The study focuses on the rate of biliopancreatic events (EBP), recurrence of acute cholecystitis, quality of life impact, and cost differences between these strategies. The goal is to provide evidence to help health professionals choose the best treatment for non-operable patients with this condition. Participants will be randomly assigned to one of two groups. Both groups start antibiotic treatment upon diagnosis following the Tokyo 2018 clinical guidelines. The non-endoscopic group receives antibiotics only, while the endoscopic group undergoes EUS-GBD, where a metal stent is placed via a linear echoendoscope to drain the gallbladder through the stomach or duodenum. The procedure occurs within 72 hours of admission under sedation. Antibiotic duration varies: 10-14 days for non-drained patients and 4-7 days after drainage for treated patients. During the study, patients will be monitored daily for pain, temperature, and lab tests until cholecystitis is considered cured. Regular follow-up visits occur monthly and every six months, including interviews, ultrasound checks of the stent, quality of life questionnaires, and adverse event monitoring. Researchers will track biliopancreatic events, healing time, hospital stay length, antibiotic use, mortality, and costs over a two-year follow-up period. Data is collected anonymously and securely, with patient consent obtained before participation.
CONDITIONS
Brief Title
Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient older than 18 years.
- Definitive diagnosis of acute lithiasic cholecystitis according to the GP Tokyo 2018 criteria.
- Surgical decision of inoperable patient due to age (≥80 years), ASA class III or higher, Charlson Comorbidity Index > 5, Karnofsky score < 50, or patient choice not to have surgery.
- Signed informed consent to participate in the study.
You will not qualify if you...
- Operable acute cholecystitis.
- Patient refusal to participate.
- Altered gastrointestinal anatomy from previous hepatobiliary or upper GI surgery.
- Presence of ascites.
- Inability to tolerate sedation for endoscopy or contraindications to endoscopy.
- Decompensated cirrhosis, portal hypertension, or gastric varices.
- Uncorrectable blood clotting disorders (INR >1.5 or platelet count <50,000/mm3).
- Other diagnoses on admission such as choledocholithiasis, liver abscesses, acute pancreatitis, or biliopancreatic tumors.
- Hemodynamic instability.
- Baseline ECOG performance status ≥4.
- Life expectancy less than 6 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 to 14 days of antibiotic treatment in the non-endoscopic group and 4 to 7 days after drainage in the endoscopic group, until the acute cholecystitis is cured
Participants receive either endoscopic gallbladder drainage using a linear echoendoscope and metal stent placement or non-endoscopic management with antibiotic treatment following clinical guidelines.
Daily evaluations during treatment including pain scale, temperature, and periodic blood tests
Duration - Up to 2 years
Participants are monitored for complications, quality of life, and biliopancreatic events with scheduled visits and telephone interviews.
Monthly visits initially and then every six months, with telephone interviews at 1, 6, and 12 months
Trial Site Locations
Total: 1 location
1
Hospital Universitario de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
J
Jesús JU Urmán, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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