Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy (INFUNDUS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gallstone; Gallstone; Cholecystitis, Acute
• Intervention / Treatment: Procedure: Indocyanine Green; Procedure: Cholangiography

• Study Type: Interventional
• Enrollment (Estimated): 294
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriel Sandblom, Associate Professor; Phone Number: +46704158218; Email: gabriel.sandblom@ki.se
• Study Contact Backup: Name: Susanna Haverinen, MD; Phone Number: +46707740080; Email: susanna.haverinen@rvn.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing laparoscopic cholecystectomy
• Verbal and written consent provided
• Age ≥ 18 years

Exclusion Criteria:

• Thyroid disease
• Allergy against ICG or Iodine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visualization with ICG; Intraoperative visualization of the bile ducts with ICG and near infrared light	Procedure: Indocyanine Green; Visualization of the bile ducts with ICG; Procedure: Cholangiography; Visualization of the bile ducts with intraoperative cholangiography
Active Comparator: Comparator; Visualization of the bile ducts with intraoperative cholangiography only.	Procedure: Cholangiography; Visualization of the bile ducts with intraoperative cholangiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intraoperative cholangiography	Time from first incision until intraoperative cholangiography	During procedure.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Västernorrland
• Investigators: Principal Investigator: Yucel Cengiz, MD, PhD, Umeå University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 5, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: cholecystectomy; Indocyanine Green; Bile duct injury; Intraoperative cholangiography; Fundus first
• Additional Relevant MeSH Terms: Calculi; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis; Gallstones; Cholecystitis, Acute; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: INFUNDUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data related to the study may be shared on request to the principal investigator
• IPD Sharing Time Frame: January 2026 to December 2030
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No