Gallstone, Gallstone; Cholecystitis, Acute
Conditions
Keywords
cholecystectomy, Indocyanine Green, Bile duct injury, Intraoperative cholangiography, Fundus first
Brief summary
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
PROCEDUREIndocyanine Green
Visualization of the bile ducts with ICG
PROCEDURECholangiography
Visualization of the bile ducts with intraoperative cholangiography
Sponsors
Region Västernorrland
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing laparoscopic cholecystectomy * Verbal and written consent provided * Age ≥ 18 years
Exclusion criteria
* Thyroid disease * Allergy against ICG or Iodine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to intraoperative cholangiography | During procedure. | Time from first incision until intraoperative cholangiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total operative time | During procedure | Time from first incision to closure of the wounds |
| Intraoperative gallbladder perforation | During procedure | Intraoperative iatrogenic gallbladder perforation |
| Procedure-related complications | Up to 30 days postoperatively | Complications related to the cholecystectomy confirmed intraoperatively or postoperatively |
| Surgeon perception of complexity | During procedure | The perception of the complexity of the procedure rated by the surgeon on a numeric rating scale from 0 to 10 where 10 indicates the highest level of complexity |
| Patient reported outcome | Up to 30 days postoperatively | Symptoms and satisfaction rated by the patient 30 days postoperatively on a numeric rating scale from 0 to 10 where 10 indicates the highest level of satisfaction and absence of symptoms |
| Conversion from laparoscopic to open cholecystectomy | During procedure | Decision to convert from laparoscopic to open cholecystectomy taken intraoperatively |
Contacts
Primary ContactGabriel Sandblom, Associate Professor
Backup ContactSusanna Haverinen, MD
Outcome results
None listed