Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy

NCT06918210 | Not Yet Recruiting

• 1 other identifier: INFUNDUS
• Study Type: interventional
• Target: 294
• Locations: 0 countries
• Sites: N/A

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

Keywords

cholecystectomy; Indocyanine Green; Bile duct injury; Intraoperative cholangiography; Fundus first

Outcome Measures

Primary Outcomes (1)

• Time to intraoperative cholangiography

  Time from first incision until intraoperative cholangiography

  During procedure.

Secondary Outcomes (6)

• Procedure-related complications

  Up to 30 days postoperatively

• Total operative time

  During procedure

• Intraoperative gallbladder perforation

  During procedure

• Conversion from laparoscopic to open cholecystectomy

  During procedure

• Surgeon perception of complexity

  During procedure

Study Arms (2)

Visualization with ICG

EXPERIMENTAL

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

Procedure: Indocyanine Green; Procedure: Cholangiography

Comparator

ACTIVE COMPARATOR

Visualization of the bile ducts with intraoperative cholangiography only.

Procedure: Cholangiography

Interventions

Indocyanine Green PROCEDURE

Visualization of the bile ducts with ICG

Visualization with ICG

Cholangiography PROCEDURE

Visualization of the bile ducts with intraoperative cholangiography

Comparator; Visualization with ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Thyroid disease
• Allergy against ICG or Iodine

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Västernorrland: collaborator

MeSH Terms

Conditions

Gallstones; Cholecystitis

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yucel Cengiz, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Sandblom, Associate Professor

CONTACT

+46704158218; gabriel.sandblom@ki.se

Susanna Haverinen, MD

CONTACT

+46707740080; susanna.haverinen@rvn.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 9, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January 2026 to December 2030