Clinical trial NCT06918210: Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy
Official title: Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gallstone
Gallstone; Cholecystitis, Acute
Keywords: cholecystectomy
Indocyanine Green
Bile duct injury
Intraoperative cholangiography
Fundus first
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Västernorrland
First posted: 2025-04-09
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to intraoperative cholangiography
timeFrame: During procedure.
Secondary outcomes:
measure: Procedure-related complications
timeFrame: Up to 30 days postoperatively
measure: Total operative time
timeFrame: During procedure
measure: Intraoperative gallbladder perforation
timeFrame: During procedure
measure: Conversion from laparoscopic to open cholecystectomy
timeFrame: During procedure
measure: Surgeon perception of complexity
timeFrame: During procedure
measure: Patient reported outcome
timeFrame: Up to 30 days postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Umeå University
name: Yucel Cengiz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: