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Acute lithiasis cholecystitis (ALC) is the third most common cause of surgical emergency admission. The initial treatment of ALC associates a medical support and a cholecystectomy, preferentially performed laparoscopically in the first 5 days of evolution. During the surgery, intraoperative cholangiography (CPO) using a contrast product is the "gold standard" to identify the bile ducts. However CPO is performed in approximately 30% of laparoscopic cholecystectomy.
Laparoscopic cholecystectomy for ALC is associated with an increase in the rate of biliary ducts injuries compared with cholecystectomy for symptomatic vesicular lithiasis, evaluated at 0.8 % versus 0.1 %. Its higher rate is related to local inflammation that alters the biliary anatomy and complicates the identification of the bile ducts. Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| indocyanine green | Experimental | During the surgery, intraoperative cholangiography using indocyanine green will be performed |
|
| standard cpo | Active Comparator | During the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic cholecystectomy | Procedure | laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of surgical procedure after Indocyanine green injection | Change of surgical procedure after Indocyanine green injection compared to intraoperative cholangiography (CPO) using a contrast product as the "gold standard" to identify the bile ducts. Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time. | day 0 = the day of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green | Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green | day 0 = the day of the surgery |
| Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osama ABOU ARAB, MD | CHU Amiens | Principal Investigator |
| Emilie Dumange Chapuis-Roux, MD | CHU Amiens | Principal Investigator |
| Ralucar Macovei, MD | CHU Amiens | Principal Investigator |
| Baptiste Brac, MD | CHU Amiens | Principal Investigator |
| Aurélien Gracient, MD | CHU Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80480 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40716885 | Result | Defives H, Chive E, Diouf M, Ammar-Khodja N, Pellegrin A, Werey F, Yvart-Degardin J, Sabbagh C, Regimbeau JM. Value of intravenous cholangiography with indocyanine green during laparoscopic cholecystectomy for grade I or II acute lithiasic cholecystitis: Results of a prospective, open, randomized, monocentric study (VIFCAL trial). Curr Probl Surg. 2025 Aug;69:101788. doi: 10.1016/j.cpsurg.2025.101788. Epub 2025 May 2. No abstract available. |
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| systematic intraoperative cholangiography | Diagnostic Test | systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group) |
|
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection |
| day 0 = the day of the surgery |
| Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection | Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection | day 0 = the day of the surgery |
| ID | Term |
|---|---|
| D020347 | Lithiasis |
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
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