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| Name | Class |
|---|---|
| Region Västernorrland | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visualization with ICG | Experimental | Intraoperative visualization of the bile ducts with ICG and near infrared light |
|
| Comparator | Active Comparator | Visualization of the bile ducts with intraoperative cholangiography only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green | Procedure | Visualization of the bile ducts with ICG |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to intraoperative cholangiography | Time from first incision until intraoperative cholangiography | During procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related complications | Complications related to the cholecystectomy confirmed intraoperatively or postoperatively | Up to 30 days postoperatively |
| Total operative time | Time from first incision to closure of the wounds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel Sandblom, Associate Professor | Contact | +46704158218 | gabriel.sandblom@ki.se | |
| Susanna Haverinen, MD | Contact | +46707740080 | susanna.haverinen@rvn.se |
| Name | Affiliation | Role |
|---|---|---|
| Yucel Cengiz, MD, PhD | Umeå University | Principal Investigator |
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Data related to the study may be shared on request to the principal investigator
January 2026 to December 2030
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Cholangiography |
| Procedure |
Visualization of the bile ducts with intraoperative cholangiography |
|
| During procedure |
| Intraoperative gallbladder perforation | Intraoperative iatrogenic gallbladder perforation | During procedure |
| Conversion from laparoscopic to open cholecystectomy | Decision to convert from laparoscopic to open cholecystectomy taken intraoperatively | During procedure |
| Surgeon perception of complexity | 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 | During procedure |
| Patient reported outcome | 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 | Up to 30 days postoperatively |
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |