An interventional study of Indocyanine Green and Cholangiography in Gallstone and Gallstone; Cholecystitis, Acute, sponsored by Karolinska Institutet. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 294 is above the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Exclusion Criteria:
Intraoperative visualization of the bile ducts with ICG and near infrared light
Procedure: Indocyanine Green · Procedure: Cholangiography
Visualization of the bile ducts with intraoperative cholangiography only.
Procedure: Cholangiography
Visualization of the bile ducts with ICG
Visualization of the bile ducts with intraoperative cholangiography
Time to intraoperative cholangiography
Time from first incision until intraoperative cholangiography
Time frame: During procedure.
Procedure-related complications
Complications related to the cholecystectomy confirmed intraoperatively or postoperatively
Time frame: Up to 30 days postoperatively
Total operative time
Time from first incision to closure of the wounds
Time frame: During procedure
Intraoperative gallbladder perforation
Intraoperative iatrogenic gallbladder perforation
Time frame: During procedure
Conversion from laparoscopic to open cholecystectomy
Decision to convert from laparoscopic to open cholecystectomy taken intraoperatively
Time frame: 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
Time frame: 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
Time frame: Up to 30 days postoperatively
No study locations are listed for this record.
Plan to share: Yes — Data related to the study may be shared on request to the principal investigator
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: January 2026 to December 2030
Data sharing details ↗ · ki.se
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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