In short
Currently, there are 2 ongoing clinical trials investigating new approaches to treating acute cholecystitis, a sudden inflammation of the gallbladder. These studies are exploring surgical techniques and antibiotic strategies to improve outcomes for patients requiring gallbladder removal. The trials are being conducted in Spain and Finland.
Clinical trial locations
- Finland
- Spain
Study on Indocyanine Green for Patients Undergoing Emergency Surgery for Acute Cholecystitis
This trial, taking place in Spain, is investigating whether using a special dye called indocyanine green can help make emergency gallbladder surgery faster and safer. When the gallbladder becomes inflamed due to acute cholecystitis, patients often need urgent surgery to remove it through a minimally invasive procedure known as laparoscopic cholecystectomy.
Who can participate:
- Adults over 18 years old who need urgent laparoscopic cholecystectomy for acute cholecystitis
- Patients who can read and understand the study information and sign an informed consent form
Who cannot participate:
- Patients unable to undergo surgery safely
- Those with severe heart or lung problems that make surgery risky
- Patients allergic to indocyanine green
- Pregnant or breastfeeding women
- Patients with severe liver disease
- Those who have had previous surgery on the bile duct
- Patients with a history of severe allergic reactions
- Those unable to give informed consent
What the study involves: The main goal is to determine if using indocyanine green can reduce the time needed for surgery by at least 10 minutes compared to traditional methods. This dye is given through a vein before surgery and helps surgeons see the bile ducts more clearly during the operation. Better visibility can potentially reduce the risk of accidentally injuring the bile ducts, which is an important safety concern during gallbladder surgery. The study measures the time from the first incision to closing the skin to see if this approach makes the procedure more efficient.
Investigational treatment: Indocyanine green is the substance being tested in this trial. It is a fluorescent dye that, when exposed to special near-infrared light during surgery, makes certain structures glow, helping surgeons navigate more safely and quickly.
Study on Preoperative Antibiotics for Patients with Acute Cholecystitis: Comparing Ertapenem, Ciprofloxacin, and Cefuroxime
This Finnish study is comparing different antibiotic approaches for patients with mild to moderate acute cholecystitis who need gallbladder removal surgery. Specifically, researchers want to know whether giving a single dose of antibiotics before surgery works just as well as giving continuous antibiotics in preventing infections after the operation.
Who can participate:
- Adults aged 18 to 64 years
- Patients diagnosed with mild or moderate acute cholecystitis according to Tokyo Guidelines
- Both men and women
- Individuals not in vulnerable population groups
Who cannot participate:
- Patients with a history of allergic reactions to antibiotics
- Those who had surgery within the past 30 days
- Patients with severe liver or kidney disease
- Pregnant or breastfeeding women
- Those currently participating in another clinical trial
- Patients with immune system disorders
- Those with uncontrolled diabetes
- Patients with active infections other than acute cholecystitis
What the study involves: Participants are randomly assigned to one of two groups. One group receives a single dose of ertapenem (1 gram) given through a vein. The other group receives continuous doses of ciprofloxacin and cefuroxime until surgery. After the cholecystectomy, patients are monitored for 30 days to track any infections or complications. The study also looks at whether the surgery needs to be changed from the less invasive laparoscopic approach to open surgery, overall complication rates, and any side effects from the antibiotics.
Investigational treatments: The trial compares three antibiotics: ertapenem (marketed as INVANZ), ciprofloxacin (marketed as Ciprofloxacin Fresenius Kabi), and cefuroxime (marketed as Cefuroxime Orion Pharma). All are given through intravenous infusion. The research aims to determine if using fewer antibiotics can still effectively prevent post-surgical infections while potentially reducing side effects and the risk of antibiotic resistance.
Summary
The two ongoing clinical trials for acute cholecystitis represent different approaches to improving patient outcomes. The Spanish trial focuses on surgical innovation using indocyanine green dye to enhance visualization during emergency gallbladder removal, potentially making the procedure faster and safer. The Finnish trial addresses antibiotic stewardship by comparing single-dose versus continuous antibiotic treatment before surgery.
These studies reflect current priorities in medical research: improving surgical techniques and optimizing antibiotic use. Both trials target patients requiring cholecystectomy for acute cholecystitis but differ in their specific inclusion criteria, with the Finnish study limiting participation to those aged 18-64 with mild to moderate disease, while the Spanish trial includes all adults over 18 requiring urgent surgery.
Geographically, the trials are distributed across different European countries, with one in Southern Europe and one in Northern Europe. Each study addresses distinct aspects of care—one surgical and one medical—demonstrating the multifaceted approach needed to optimize treatment for this common condition.
