LOW DOse vs standard dose and administration TIme in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy: a randomised clinical trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion De Investigacion Biomedica De Salamanca

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

13 Feb 2026 → ongoing

Decision date (initial)

2025-08-19

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Instituto de Investigación Biomédica de Salamanca

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To analyze the differences between treatment groups
[standard dose of 2.5 mg administered >3 hours preoperatively vs. reduced dose (0.25 mg) administered immediately preoperatively (15 minutes)], during laparoscopic cholecystectomy (LC), in terms of:

Visualization of extrahepatic biliary structures.
Degree of visualization of these structures.
Degree of background hepatic fluorescence disturbance.
Perceived utility of the technique across treatment groups.

Secondary objectives 12

1. To analyze the influence of body mass index (BMI) on fluorescence cholangiography (FC) outcomes during laparoscopic cholecystectomy (LC)
2. To analyze the influence of the type of biliary pathology requiring surgery on fluorescence cholangiography (FC) outcomes during laparoscopic cholecystectomy (LC).
3. To analyze the influence of the type of surgery on fluorescence cholangiography (FC) outcomes during laparoscopic cholecystectomy (LC).
4. To analyze the influence of previous inflammatory changes on fluorescence cholangiography (FC) outcomes during laparoscopic cholecystectomy (LC).
5. To analyze the influence of surgical difficulty grade on FC outcomes during LC.
6. To analyze the influence of prior instrumentation of the gallbladder or biliary tract on FC outcomes during LC.
7. To analyze the impact of different laparoscopic imaging systems on FC outcomes during LC.
8. To analyze the rate of intraoperative complications related to FC during LC.
9. To analyze the rate of postoperative complications related to FC during LC.
10. To analyze hospital and 30-day mortality rates.
11. To analyze the impact of the technique on operative time, intraoperative/postoperative complications, and hospital stay.
12. To analyze the correlation between subjective and objective assessments of the procedure using the bile duct-to-liver fluorescence ratio.

Conditions and MedDRA coding

Symptomatic Cholelithiasis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Adult patient (≥18 years old) who is able to understand and sign the informed consent form.
2. Indication for: a) Elective laparoscopic cholecystectomy (LC) due to: Symptomatic cholelithiasis (history of biliary colic, acute calculous cholecystitis, choledocholithiasis, ascending acute lithiasic cholangitis, or acute biliary pancreatitis); Gallbladder polyps with indication for laparoscopic surgery. b) Early LC indication (<72 hours from hospital admission) for: Acute calculous cholecystitis; Acute acalculous cholecystitis; Complicated biliary colic. c) Indication for delayed emergency LC.

Exclusion criteria 10

1. Patient under 18 years of age.
2. Pregnancy or breastfeeding.
3. Chronic kidney disease (Stage > IIIb).
4. History of adverse reactions or allergies to indocyanine green (ICG).
5. Confirmed adverse reactions or allergies to iodinated contrast agents.
6. Functional thyroid disorders (e.g., hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma).
7. Non-deferrable/emergency gallbladder surgery.
8. Primary open (laparotomic) cholecystectomy.
9. Preoperative suspicion of gallbladder carcinoma.
10. Inability to understand the information required to participate in the study or to complete follow-up.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Rate of identification of biliary structures prior to dissection of the hepatocystic triangle.
2. Rate of identification of biliary structures after dissection of the hepatocystic triangle.
3. Degree of identification of extrahepatic biliary structures prior to dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent).
4. Degree of identification of extrahepatic biliary structures after dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent).
5. Perceived usefulness of fluorescence cholangiography during surgery (1 = not useful, 2 = moderately useful, 3 = very useful).
6. Perceived disturbance from background liver fluorescence (liver-to-duct contrast): 0 = none, 1 = slight, 2 = significant.

Secondary endpoints 3

1. Analysis on the primary variables described above, corresponding to the predictors of the technique: sex, BMI, type of biliary pathology, type of surgery, previous inflammatory changes, degree of surgical difficulty, previous instrumentation and imaging systems.
2. Analysis of intraoperative and postoperative complication rates of the technique, categorised by treatment group.
3. Analysis of the relationship between surgical time and length of hospital stay.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion De Investigacion Biomedica De Salamanca

Sponsor organisation

Fundacion De Investigacion Biomedica De Salamanca

Address

Paseo De San Vicente 58-182

City

Salamanca

Postcode

37007

Country

Spain

Scientific contact point

Organisation

Fundacion Instituto De Estudios De Ciencias De La Salud De Castilla Y Leon

Contact name

Esperanza Lopez Franco

Public contact point

Organisation

Fundacion Instituto De Estudios De Ciencias De La Salud De Castilla Y Leon

Contact name

Carmen Arias de la Fuente

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications