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Compares treatment options for Acute Cholecystitis
Official title EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy
ClinicalTrials.gov ID: NCT05893511
What this study is testing
What is Antibiotics first?
Antibiotics first is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute cholecystitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Objectives Acute cholecystitis commonly occurs in elderly patients who are at high-risk for surgery. Whether upfront Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is advantageous over antibiotics first for mild acute cholecystitis is uncertain.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Consecutive patients aged ≥ 18 years old
- Suffering from grade 1 or 2 acute calculous cholecystitis\
- At very high-risk for early laparoscopic cholecystectomy due to poor premorbid conditions\ \ or elderly patients suffering from acute cholecystitis...
You likely can't join if
- Patients with the following conditions are excluded from the study:
- Pregnancy
- Patients unwilling to undergo follow-up assessments
- Patients with suspected gangrene or perforation of the gallbladder
- Grade III acute cholecystitis33
- Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
See the full eligibility criteria
- Consecutive patients aged ≥ 18 years old
- Suffering from grade 1 or 2 acute calculous cholecystitis\
- At very high-risk for early laparoscopic cholecystectomy due to poor premorbid conditions\ \ or elderly patients suffering from acute cholecystitis but refused operations
- Patients with the following conditions are excluded from the study:
- Pregnancy
- Patients unwilling to undergo follow-up assessments
- Patients with suspected gangrene or perforation of the gallbladder
- Grade III acute cholecystitis33
- Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
- Patients with liver cirrhosis, portal hypertension and/or gastric varices
- Abnormal coagulation: International normalized ratio (INR) \> 1.5 and/or platelets \< 50.000/mm3
- Previous drainage of the gallbladder
- Patients suffering acute cholecystitis due to malignant cystic duct obstruction
- Patients with life expectancy of less than 3 years
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, HONG KONG, Hong Kong
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, HONG KONG, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.