Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indocyanine Green, Cholangiography.
- Who it may be relevant to
- Registry conditions: Gallstone, Gallstone; Cholecystitis, Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Laparoscopic cholecystectomy is the routine method for managing gallstone disease. This is considered a safe procedure with low risk of severe complications. Lesions to the deep bile ducts is, however, a rare complication from laparoscopic cholecystectomy that may have devastating consequences. The risk of bile duct injuries may be reduced by adapting the surgical approach. In general, the operation is started from the lower part of the gallbladder and continued upwards. It may, however, also be initiated from the top of the gallbladder and extended downwards. This approach, also termed fundus first, is routine at a few units. By injecting Indocyanin Green (ICG) that is excreted into the bile, the bile ducts may be visualized using near infrared light. This is a technique for mapping the anatomical structures adjacent to the gallbladder that has been used in previous studies for preventing bile duct injuries. This method has, however, not been tested at units where fundus first is the routine surgical technique. In the present randomized controlled trial, the investigators intend to evaluate the safety of ICG as a means for reducing the risk of bile duct lesions and to see if it works as intended. Altogether 294 operations for gallstones will be included in the study. The patients will be randomized to surgery with or without ICG. Regardless of the randomization, all operations will be undertaken with the fundus first technique. Thirty days after the operation, all data related to the operation are retrieved from the patient records by an assessor that does not know what group the patient was randomized to. The primary endpoint of the study is the time required from the start of the operation until intraoperative cholangiography is done. In addition, total operative time, all surgical complications and need for converting the operation to an open procedure will be recorded.
Interventions
- Procedure Indocyanine Green
Visualization of the bile ducts with ICG - Procedure Cholangiography
Visualization of the bile ducts with intraoperative cholangiography
Primary outcome measures
- Time to intraoperative cholangiography [Time frame: During procedure.]
Secondary outcome measures (6)
- Procedure-related complications [Time frame: Up to 30 days postoperatively]
- Total operative time [Time frame: During procedure]
- Intraoperative gallbladder perforation [Time frame: During procedure]
- Conversion from laparoscopic to open cholecystectomy [Time frame: During procedure]
- Surgeon perception of complexity [Time frame: During procedure]
- Patient reported outcome [Time frame: Up to 30 days postoperatively]
Eligibility criteria
Inclusion criteria
- Patients undergoing laparoscopic cholecystectomy
- Verbal and written consent provided
- Age ≥ 18 years
Exclusion criteria
- Thyroid disease
- Allergy against ICG or Iodine
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06918210 · INFUNDUS