GallstoneINFUNDUSNCT06918210
Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy
A study testing Indocyanine Green and Cholangiography in people with Gallstone and Gallstone; Cholecystitis, Acute, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone, Gallstone; Cholecystitis, Acute
- What is being tested?
- Indocyanine Green and Cholangiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic cholecystectomy
- Verbal and written consent provided
- Age ≥ 18 years
Who cannot join
- Thyroid disease
- Allergy against ICG or Iodine
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- Indocyanine Green, Cholangiography
- Keywords
- cholecystectomy, Indocyanine Green, Bile duct injury, Intraoperative cholangiography, Fundus first
- Medical subject headings
- Gallstones, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenProcedure or surgery
Visualization of the bile ducts with ICG
CholangiographyProcedure or surgery
Visualization of the bile ducts with intraoperative cholangiography
| Study group | Role | What they receive |
|---|---|---|
| Visualization with ICG | Experimental | Intraoperative visualization of the bile ducts with ICG and near infrared light Receives: Procedure: Indocyanine Green; Procedure: Cholangiography |
| Comparator | Active comparator | Visualization of the bile ducts with intraoperative cholangiography only. Receives: Procedure: Cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intraoperative cholangiography
Time from first incision until intraoperative cholangiography
Measured: During procedure.
Secondary outcomes (6)
Procedure-related complications
Complications related to the cholecystectomy confirmed intraoperatively or postoperatively
Measured: Up to 30 days postoperatively
Total operative time
Time from first incision to closure of the wounds
Measured: During procedure
Intraoperative gallbladder perforation
Intraoperative iatrogenic gallbladder perforation
Measured: During procedure
Conversion from laparoscopic to open cholecystectomy
Decision to convert from laparoscopic to open cholecystectomy taken intraoperatively
Measured: 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
Measured: 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
Measured: Up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstoneStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västernorrland
- Responsible party
- Principal investigator, Gabriel Sandblom, Karolinska Institutet
- Investigators
- Yucel Cengiz, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918210
- Sponsor's protocol ID
- INFUNDUS
- Acronym
- INFUNDUS
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data related to the study may be shared on request to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06918210
- Acronym / sponsor ID
- INFUNDUS / INFUNDUS
- Conditions
- Gallstone, Gallstone; Cholecystitis, Acute
- Keywords
- cholecystectomy, Indocyanine Green, Bile duct injury, Intraoperative cholangiography, Fundus first
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Västernorrland
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visualization with ICG | Experimental | Procedure: Indocyanine Green, Procedure: CholangiographyIntraoperative visualization of the bile ducts with ICG and near infrared light |
| Comparator | Active comparator | Procedure: CholangiographyVisualization of the bile ducts with intraoperative cholangiography only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing laparoscopic cholecystectomy
- Verbal and written consent provided
- Age ≥ 18 years
Key exclusion criteria (2 listed)
- Thyroid disease
- Allergy against ICG or Iodine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine GreenVisualization of the bile ducts with ICG | Procedure or surgery | Visualization with ICG |
| CholangiographyVisualization of the bile ducts with intraoperative cholangiography | Procedure or surgery | Comparator, Visualization with ICG |
Primary outcome
Time to intraoperative cholangiography
Time frame: During procedure.
Time from first incision until intraoperative cholangiography
6 secondary outcomes
Procedure-related complications
Time frame: Up to 30 days postoperatively
Total operative time
Time frame: During procedure
Intraoperative gallbladder perforation
Time frame: During procedure
Conversion from laparoscopic to open cholecystectomy
Time frame: During procedure
Surgeon perception of complexity
Time frame: During procedure
Patient reported outcome
Time frame: Up to 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Yes. Data related to the study may be shared on request to the principal investigator
Related trials for Gallstone
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Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
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RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yucel Cengiz, MD, PhD principal investigator
Umeå University
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green and Cholangiography in people with Gallstone and Gallstone; Cholecystitis, Acute, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Sandblom, Associate Professor (+46704158218, gabriel.sandblom@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to intraoperative cholangiography (time frame: During procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.