INDOCYANINE GREEN for Symptomatic cholelithiasis

Inclusion criteria

• {"criterion_text":"- Adult patient (≥18 years old) who is able to understand and sign the informed consent form."}
• {"criterion_text":"- 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

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

Primary endpoints

• {"endpoint_text":"- Rate of identification of biliary structures prior to dissection of the hepatocystic triangle.","definition_or_measurement_approach":"Measured as the rate (proportion) of biliary structures identified prior to dissection of the hepatocystic triangle."}
• {"endpoint_text":"- Rate of identification of biliary structures after dissection of the hepatocystic triangle.","definition_or_measurement_approach":"Measured as the rate (proportion) of biliary structures identified after dissection of the hepatocystic triangle."}
• {"endpoint_text":"- Degree of identification of extrahepatic biliary structures prior to dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent).","definition_or_measurement_approach":"Ordinal score: 1 = poor, 2 = good, 3 = excellent (degree of identification prior to dissection)."}
• {"endpoint_text":"- Degree of identification of extrahepatic biliary structures after dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent).","definition_or_measurement_approach":"Ordinal score: 1 = poor, 2 = good, 3 = excellent (degree of identification after dissection)."}
• {"endpoint_text":"- Perceived usefulness of fluorescence cholangiography during surgery (1 = not useful, 2 = moderately useful, 3 = very useful).","definition_or_measurement_approach":"Ordinal score: 1 = not useful, 2 = moderately useful, 3 = very useful (surgeon-perceived usefulness)."}
• {"endpoint_text":"- Perceived disturbance from background liver fluorescence (liver-to-duct contrast): 0 = none, 1 = slight, 2 = significant.","definition_or_measurement_approach":"Ordinal score for liver-to-duct contrast disturbance: 0 = none, 1 = slight, 2 = significant."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Subgroup analyses of primary variables by listed predictors (sex, BMI, biliary pathology type, surgery type, prior inflammatory changes, surgical difficulty, prior instrumentation, imaging systems)."}
• {"endpoint_text":"- Analysis of intraoperative and postoperative complication rates of the technique, categorised by treatment group.","definition_or_measurement_approach":"Complication rates (intraoperative and postoperative) compared between treatment groups."}
• {"endpoint_text":"- Analysis of the relationship between surgical time and length of hospital stay.","definition_or_measurement_approach":"Analysis of correlation/association between surgical time and hospital length of stay."}

Spain

Earliest CTIS Part Ii Submission Date

01-08-2025

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

130

Number Of Sites

2

Number Of Participants

122

Primary sponsor

Full Name

Fundacion De Investigacion Biomedica De Salamanca

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Instituto de Investigación Biomédica de Salamanca","duties_or_roles":"Monetary support","organisation_type":""}