Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy

NCT ID: NCT06918210

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-07-31

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.

Conditions

Gallstone; Gallstone; Cholecystitis, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Visualization with ICG

Intraoperative visualization of the bile ducts with ICG and near infrared light

Group Type: EXPERIMENTAL

Indocyanine Green

Intervention Type: PROCEDURE

Visualization of the bile ducts with ICG

Cholangiography

Intervention Type: PROCEDURE

Visualization of the bile ducts with intraoperative cholangiography

Comparator

Visualization of the bile ducts with intraoperative cholangiography only.

Group Type: ACTIVE_COMPARATOR

Cholangiography

Intervention Type: PROCEDURE

Visualization of the bile ducts with intraoperative cholangiography

Interventions

Indocyanine Green

Visualization of the bile ducts with ICG

Intervention Type: PROCEDURE

Cholangiography

Visualization of the bile ducts with intraoperative cholangiography

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Västernorrland

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Sandblom

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yucel Cengiz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Central Contacts

Gabriel Sandblom, Associate Professor

Role: CONTACT

gabriel.sandblom@ki.se

+46704158218

Susanna Haverinen, MD

Role: CONTACT

susanna.haverinen@rvn.se

+46707740080

Other Identifiers

INFUNDUS

Identifier Type: -

Identifier Source: org_study_id