Laparoscopic Cholecystectomy
Conditions
Brief summary
Laparoscopic cholecystectomy is one of the most performed surgical procedures worldwide. One of its most serious complications is injury to the main bile duct, with an incidence of less than 1%. There are different surgical strategies that try to reduce this complication, with indocyanine green fluorescence cholangiography being one of the most recent to appear. This technique is becoming a great tool during laparoscopic cholecystectomy. Despite the great rise of the procedure, today there is a great disparity in the administration protocols of indocyanine green during the procedure. Goals. The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.
Detailed description
Symptomatic cholelithiasis is a pathology of great relevance in the world population, with prevalence rates of up to 20%. The standard treatment for cholelithiasis is laparoscopic cholecystectomy (LC). One of the most serious complications of LC is injury to the main bile duct (LVB). Although this complication has incidences of less than 1% (0.3-0.7% in the different series), the consequences it causes are highly relevant. LVB is related to a significant increase in patient morbidity and mortality, a significant deterioration in quality of life, a very significant increase in healthcare costs and not insignificant medical-legal consequences. Indocyanine green fluorescence cholangiography (CF-VI) is a novel technique that allows precise and real-time anatomical visualization of the extrahepatic biliary anatomy, facilitating surgery and reducing the risk of complications. Currently, there are large differences in LV administration protocols during CF in LC. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization. In relation to the dose, there are many protocols for IV administration, by means of a single dose or a dose adjusted for the patient's body weight. Some authors advocate the administration of IV 24 hours before the procedure, in order to avoid hepatic fluorescence. However, in the context of major outpatient surgery, outpatient surgery or short-stay surgery, we believe that this practice is not currently logistically feasible. Other groups administer the IV with a variable range of time interval. The recent preliminary results of the European Registry of Fluorescent Image Guided Surgery show the great disparity of preoperative LV administration protocols. Therefore, it is necessary to protocolize the administration of the drug based on the results of randomized clinical trials.. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization.
Interventions
DRUGVERDYE powder for solution for injection 25 mg
Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
Sponsors
Instituto de Investigación Biomédica de Salamanca
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects included in this CT will be treated with VI \[Verdye (Diagnostic Green GMBH, Aschheim-Dornach, Germany)\]. Single dose and weight-adjusted dose and different administration intervals will be analyzed. Low-intervention clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years. * Autonomy, self-sufficiency and independence. * Scheduled CL indication: * Symptomatic cholelithiasis: history of biliary colic, acute lithiasic cholecystitis, choledocholithiasis, acute ascending cholangitis of lithiasic origin or acute lithiasic pancreatitis. * Gallbladder polyps with indication for laparoscopic surgery. * Vesicular adenomyomatosis with indication for laparoscopic surgery. * Indication of early LC (\<72 hours of admission for acute stone cholecystitis/acute acalculous cholecystitis/complicated biliary colic). * Deferred urgency LC indication. * Understanding of information. * Signature of the informed consent.
Exclusion criteria
* Age less than 18 years. * Disability. * Pregnancy or lactation. * Chronic kidney disease (Stage \> IIIb). * Previous adverse reactions or allergies to VI. * Previous adverse reactions or allergies to VI excipients. * Adverse reactions or confirmed allergies to iodinated contrast agents. * Functional thyroid pathology (hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma). * Urgent non-deferrable/emergent gallbladder surgery. * Initial surgery by laparotomy. * Previous suspicion of gallbladder carcinoma. * Inability to understand the information needed to participate in the study. * Rejection of inclusion within the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | During surgical procedure, before beginning the dissection of the hepatocystic triangle. | Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection |
| Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | During surgical procedure, after dissection of the hepatocystic triangle. | Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | During surgical procedure, before beginning the dissection of the hepatocystic triangle. | Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. |
| Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | During surgical procedure, after the disection of the hepatocystic triangle has begun. | Degree of identification of biliary structures after dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. |
| Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | During surgical procedure | Extent to which fluorescence cholangiography was perceived as useful for surgery. Participants were assigned toeach category according to the intraoperative identification of distinct anatomical structures observed in each case,once the surgery has begun. The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. |
| Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | During surgical procedure | Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. Participants were assigned to each category according to the intraoperative identification of distinct anatomical structures observed in each case, once the surgery has begun. The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name. |
Countries
Spain
Participant flow
Recruitment details
The annual rate of LC in the two hospitals in the study is over 300 surgeries per year. In order to recruit 200 in both centres, a review waiting list will be conducted. Patients who meet the inclusion criteria will be given the necessary information and, after signing the informed consent form, will be included in the trial.
Pre-assignment details
Screening details: Patients scheduled for laparoscopic cholecystectomy who meet all inclusion criteria and none of the exclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| Fixed Dose 3 Hours Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery. | 47 |
| Fixed Dose 30 Min Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery). | 45 |
| Weight-adjusted Dose 3 Hour Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery. | 44 |
| Weight-adjusted Dose 30 Min Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery). | 60 |
| Total | 196 |
Baseline characteristics
| Characteristic | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min | Total |
|---|---|---|---|---|---|
| Age, Customized Between 20 and 91 years | 47 participants | 45 participants | 44 participants | 60 participants | 200 participants |
| Body mass index (BMI) | 30.5 Kilogram per square meter STANDARD_DEVIATION 6.3 | 27.1 Kilogram per square meter STANDARD_DEVIATION 4.8 | 28.9 Kilogram per square meter STANDARD_DEVIATION 6.6 | 28.4 Kilogram per square meter STANDARD_DEVIATION 7.1 | 27.9 Kilogram per square meter STANDARD_DEVIATION 8.2 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 33 Participants | 25 Participants | 25 Participants | 38 Participants | 121 Participants |
| Sex: Female, Male Male | 14 Participants | 20 Participants | 19 Participants | 22 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 196 |
| other Total, other adverse events | 66 / 196 |
| serious Total, serious adverse events | 13 / 196 |
Outcome results
Primary
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Time frame: During surgical procedure, after dissection of the hepatocystic triangle.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fixed Dose 3 Hours | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 6 | 6 Participants |
| Fixed Dose 3 Hours | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 4 | 41 Participants |
| Fixed Dose 3 Hours | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 2 | 42 Participants |
| Fixed Dose 3 Hours | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 3 | 41 Participants |
| Fixed Dose 3 Hours | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 1 | 40 Participants |
| Fixed Dose 3 Hours | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 5 | 24 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 5 | 26 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 6 | 5 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 2 | 33 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 1 | 38 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 3 | 35 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 4 | 35 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 1 | 36 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 2 | 35 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 5 | 25 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 4 | 36 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 6 | 5 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 3 | 36 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 6 | 3 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 1 | 45 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 2 | 48 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 3 | 40 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 4 | 40 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | Category 5 | 36 Participants |
Primary
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Time frame: During surgical procedure, before beginning the dissection of the hepatocystic triangle.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fixed Dose 3 Hours | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 4 | 23 Participants |
| Fixed Dose 3 Hours | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 3 | 15 Participants |
| Fixed Dose 3 Hours | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 6 | 2 Participants |
| Fixed Dose 3 Hours | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 5 | 16 Participants |
| Fixed Dose 3 Hours | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 2 | 32 Participants |
| Fixed Dose 3 Hours | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 1 | 26 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 1 | 20 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 2 | 25 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 3 | 12 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 4 | 19 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 5 | 16 Participants |
| Fixed Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 6 | 1 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 2 | 28 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 4 | 25 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 6 | 1 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 5 | 16 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 1 | 26 Participants |
| Weight-adjusted Dose 3 Hour | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 3 | 18 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 3 | 19 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 6 | 0 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 5 | 25 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 4 | 19 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 1 | 29 Participants |
| Weight-adjusted Dose 30 Min | Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | Category 2 | 36 Participants |
Secondary
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Degree of identification of biliary structures after dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Time frame: During surgical procedure, after the disection of the hepatocystic triangle has begun.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fixed Dose 3 Hours | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 5= excellent | 15 Participants |
| Fixed Dose 3 Hours | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 2=sufficient | 6 Participants |
| Fixed Dose 3 Hours | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 4= good | 12 Participants |
| Fixed Dose 3 Hours | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 1=little | 6 Participants |
| Fixed Dose 3 Hours | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 3= quite a bit | 8 Participants |
| Fixed Dose 30 Min | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 3= quite a bit | 4 Participants |
| Fixed Dose 30 Min | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 4= good | 6 Participants |
| Fixed Dose 30 Min | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 2=sufficient | 12 Participants |
| Fixed Dose 30 Min | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 1=little | 6 Participants |
| Fixed Dose 30 Min | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 5= excellent | 17 Participants |
| Weight-adjusted Dose 3 Hour | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 1=little | 5 Participants |
| Weight-adjusted Dose 3 Hour | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 3= quite a bit | 5 Participants |
| Weight-adjusted Dose 3 Hour | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 4= good | 15 Participants |
| Weight-adjusted Dose 3 Hour | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 2=sufficient | 6 Participants |
| Weight-adjusted Dose 3 Hour | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 5= excellent | 13 Participants |
| Weight-adjusted Dose 30 Min | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 4= good | 15 Participants |
| Weight-adjusted Dose 30 Min | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 3= quite a bit | 5 Participants |
| Weight-adjusted Dose 30 Min | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 1=little | 13 Participants |
| Weight-adjusted Dose 30 Min | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 5= excellent | 17 Participants |
| Weight-adjusted Dose 30 Min | Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle. | 2=sufficient | 10 Participants |
Secondary
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Time frame: During surgical procedure, before beginning the dissection of the hepatocystic triangle.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fixed Dose 3 Hours | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 4=good | 11 Participants |
| Fixed Dose 3 Hours | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 2=sufficient | 11 Participants |
| Fixed Dose 3 Hours | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 5=excellent | 7 Participants |
| Fixed Dose 3 Hours | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 3=quite a bit | 6 Participants |
| Fixed Dose 3 Hours | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 1=little | 12 Participants |
| Fixed Dose 30 Min | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 3=quite a bit | 5 Participants |
| Fixed Dose 30 Min | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 4=good | 7 Participants |
| Fixed Dose 30 Min | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 5=excellent | 6 Participants |
| Fixed Dose 30 Min | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 2=sufficient | 7 Participants |
| Fixed Dose 30 Min | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 1=little | 20 Participants |
| Weight-adjusted Dose 3 Hour | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 3=quite a bit | 9 Participants |
| Weight-adjusted Dose 3 Hour | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 1=little | 12 Participants |
| Weight-adjusted Dose 3 Hour | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 2=sufficient | 4 Participants |
| Weight-adjusted Dose 3 Hour | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 4=good | 10 Participants |
| Weight-adjusted Dose 3 Hour | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 5=excellent | 9 Participants |
| Weight-adjusted Dose 30 Min | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 4=good | 13 Participants |
| Weight-adjusted Dose 30 Min | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 2=sufficient | 11 Participants |
| Weight-adjusted Dose 30 Min | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 1=little | 25 Participants |
| Weight-adjusted Dose 30 Min | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 3=quite a bit | 3 Participants |
| Weight-adjusted Dose 30 Min | Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle. | 5=excellent | 8 Participants |
Secondary
Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery
Extent to which fluorescence cholangiography was perceived as useful for surgery. Participants were assigned toeach category according to the intraoperative identification of distinct anatomical structures observed in each case,once the surgery has begun. The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Time frame: During surgical procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fixed Dose 3 Hours | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 2= very useful | 21 Participants |
| Fixed Dose 3 Hours | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 1= moderately useful | 22 Participants |
| Fixed Dose 3 Hours | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 0= not useful | 4 Participants |
| Fixed Dose 30 Min | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 1= moderately useful | 24 Participants |
| Fixed Dose 30 Min | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 0= not useful | 9 Participants |
| Fixed Dose 30 Min | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 2= very useful | 12 Participants |
| Weight-adjusted Dose 3 Hour | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 0= not useful | 3 Participants |
| Weight-adjusted Dose 3 Hour | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 1= moderately useful | 19 Participants |
| Weight-adjusted Dose 3 Hour | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 2= very useful | 22 Participants |
| Weight-adjusted Dose 30 Min | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 1= moderately useful | 23 Participants |
| Weight-adjusted Dose 30 Min | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 2= very useful | 24 Participants |
| Weight-adjusted Dose 30 Min | Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery | 0= not useful | 13 Participants |
Secondary
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.
Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. Participants were assigned to each category according to the intraoperative identification of distinct anatomical structures observed in each case, once the surgery has begun. The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Time frame: During surgical procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fixed Dose 3 Hours | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 2 | 4 Participants |
| Fixed Dose 3 Hours | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 3 | 1 Participants |
| Fixed Dose 3 Hours | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 0 | 26 Participants |
| Fixed Dose 3 Hours | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 4 | 0 Participants |
| Fixed Dose 3 Hours | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 1 | 16 Participants |
| Fixed Dose 30 Min | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 3 | 9 Participants |
| Fixed Dose 30 Min | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 4 | 3 Participants |
| Fixed Dose 30 Min | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 1 | 17 Participants |
| Fixed Dose 30 Min | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 2 | 4 Participants |
| Fixed Dose 30 Min | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 0 | 12 Participants |
| Weight-adjusted Dose 3 Hour | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 0 | 26 Participants |
| Weight-adjusted Dose 3 Hour | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 1 | 13 Participants |
| Weight-adjusted Dose 3 Hour | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 2 | 5 Participants |
| Weight-adjusted Dose 3 Hour | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 3 | 0 Participants |
| Weight-adjusted Dose 3 Hour | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 4 | 0 Participants |
| Weight-adjusted Dose 30 Min | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 4 | 9 Participants |
| Weight-adjusted Dose 30 Min | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 0 | 7 Participants |
| Weight-adjusted Dose 30 Min | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 3 | 9 Participants |
| Weight-adjusted Dose 30 Min | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 2 | 15 Participants |
| Weight-adjusted Dose 30 Min | Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing. | Cat 1 | 20 Participants |