Laparoscopic; CholecystectomyNCT04908826
Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy
A study testing Indocyanine Green (ICG) administration in people with Laparoscopic; Cholecystectomy and Cholelithiasis; Bile Duct, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The aim of the trial is to compare the routes of administration of indocyanine green (ICG) during laparoscopic cholocystectomy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Laparoscopic; Cholecystectomy, Cholelithiasis; Bile Duct, Choledocholithiasis
- What is being tested?
- Indocyanine Green (ICG) administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGreece
- Study dates
- 3 Jan 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age older than 18 years old
- laparoscopic cholecystectomy
- elective surgery
Who cannot join
- younger than 18 years old
- no consent to participate to the study
- history of allergic reaction to iodine products
- urgent or emergent cholecystectomy
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57010
Savvas Simeonidis, MD, PhD(c)
About this study
Official title: Comparison of Administration of Indocyanine Green (ICG) for Image-Guided Laparoscopic Cholocystectomy- A Randomized, Controlled, Prospective Trial
The aim of the trial is to compare the routes of administration of indocyanine green (ICG) during laparoscopic cholocystectomy.
Read the detailed description
Laparoscopic cholecystectomy is now the method of choice for the treatment of symptomatic and complicated gallstones.
There are two major problems that can occur during and after a laparoscopic cholecystectomy. These are the remaining stones in the bile duct and the iatrogenic injuries of the bile ducts. Iatrogenic bile duct injuries are the most difficult complication of cholecystectomy and are a clinical entity that needs multifactorial treatment as it significantly increases morbidity, mortality and overall cost. Intraoperative cholangiography is used to prevent these complications.
Intraoperative cholangiography is the traditional method of identifying bile duct anatomy during laparoscopic cholecystectomy. This method has the disadvantages that both the patient and the staff are exposed to radiation, while in order to perform it, catheterization of the cystic duct must be performed, which requires surgical procedures that increase the time of the operation, while in some cases it is not technically easy. Finally, with the intraoperative cholangiography, the injuries of the bile ducts are detected, after they have taken place, therefore it helps in their timely diagnosis but does not limit the frequency of their occurrence.
Indocyanine green is a sterile, anionic, water-soluble but relatively hydrophobic tricarbocyanine molecule with a molecular weight of 751.4. It was developed in 1955 at Kodak Laboratories and in 1959 was approved for clinical use by the FDA. It has the property of fluorescing, after its administration, with a maximum absorption at 800 nm after exposure to infrared lighting. Its use offers an image of high clarity and sensitivity, target imaging, with parallel low acoustic emission. Indocyanine green has the following properties and advantages, which make it an important tool in the applications of medical sciences and studies.
Following intravenous administration, it binds to plasma lipoproteins with minimal escape into the interstitial space. Extremely important for its clinical use is the complete excretion through the bile, as well as the non-production of metabolic products. It has low toxicity in the absence of ionization, which in combination with the short half-life of the substance, provides safety for the patient in its use and application in medical and biomedical sciences. It has low costs that in combination with its ease of use facilitates its application. No expensive equipment or large learning curve required. Also the possibility of recurrence with re-administration intraoperatively can offer a number of applications in laparoscopic surgery. It has a low rate of side effects and interactions with other drugs and preparations, a major allergic reaction has been reported in the literature. The first clinical applications of indocyanine green were to assess cardiac function, liver function in cirrhotic patients before hepatectomy, and to examine the retinal vessels.
Its use in laparoscopic cholecystectomy, as already mentioned, is based on its ability to fluoresce when exposed to infrared light and in combination with the fact that when administered intravenously it is concentrated and excreted from the bile offers the possibility of intraoperative, fluorescent cholangiography that aims to identify the elements of the Callot triangle.
This study aims to demonstrate that endocyanin green cholangiography is equivalent to or better than conventional cholangiography for the diagnosis of cholelithiasis and biliary injuries. It is therefore an important clinical application that will probably facilitate surgeons both in the prevention of biliary injuries and in the intraoperative diagnosis of cholelithiasis.
Patients who will undergo laparoscopic cholecystectomy will be randomly divided into 3 (three) groups. The processing of the results will be done in the appropriate way and method. A total of 240 patients will be randomized into three groups of 80. In the first group (A) classical cholangiography will be performed. In group (B) will be performed intravenous fluorescent cholangiography with indocyanine green 6 (six) hours before the start of surgery. In the third group (C) will be performed intraoperative cholangiography with direct administration of indocyanine green to the gallbladder.
- Conditions
- Laparoscopic; Cholecystectomy, Cholelithiasis; Bile Duct, Choledocholithiasis, Stone - Biliary, Post-Op Complication, Cholangiography
- Being tested
- Indocyanine Green (ICG) administration
- Medical subject headings
- Cholelithiasis, Choledocholithiasis, Cholecystolithiasis, Postoperative Complications, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green (ICG) administrationProcedure or surgery
Also called laparoscopic cholecystectomy, intra-operative cholangiography, c-arm recording, iodine solution administration
Patients will undergo laparoscopic cholecystectomy after they are randomly divided into 3 (three) groups. A total of 240 patients will be randomized into three groups of 80. In the first group (A) standard cholangiography will be performed. In group (B) intravenous fluorescent cholangiography with indocyanine green will be performed during surgery. ICG at a dose of 0.3 mg / mL / Kg 6 (six) hours prior to surgery will be administered. In the third group (C), intraoperative cholangiography will be performed with direct administration of indocyanine green at a dose of 0.03 mg / ml / Kg to the gallbladder.
| Study group | Role | What they receive |
|---|---|---|
| Group A (standard cholangiography during surgery) | Active comparator | All patients will undergo laparoscopic cholecystectomy. In this group standard cholangiography will be performed during surgery. Standard cholangiography will be performed with selective catheterization of the cystic duct and infusion of a radiolucent substance (non-ionic low osmotic iodine). The category includes drugs such as iohexol, iopamidol, iopromide, ioversol, iobitriol, iomeprol and iodixanol. In our study we will use Xenetix (iobitriol) and perform cholangiography with C-ARM recording. Receives: Procedure: Indocyanine Green (ICG) administration |
| Group B (cholangiography with iv administration of icg prior to surgery) | Active comparator | All patients will undergo laparoscopic cholecystectomy. In this group intravenous fluorescent cholangiography with indocyanine green will be given at a dose of 0.3 mg / mL / Kg 6 (six) hours before the start of surgery.The bile duct system will be recorded with a special camera (Karl Storz NIR / ICG). Receives: Procedure: Indocyanine Green (ICG) administration |
| Group C (cholangiography with direct administration of icg to the bile duct system during surgery) | Active comparator | All patients will undergo laparoscopic cholecystectomy. In the third group intraoperative cholangiography will be performed with direct administration of indocyanine green at a dose of 0.03 mg / ml / Kg to the bile duct cyst. Receives: Procedure: Indocyanine Green (ICG) administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful imaging of biliary system
The anatomy of the extrahepatic bile ducts will be orally determined by the surgeon and the cases in which the oral description will coincide with the findings of cholangiography or not and where there were differences will be recorded.
Measured: intra-operatively
operation duration
minutes
Measured: intra-operatively
intra-operative complications (bleeding, bile duct leakage, bile duct injury)
presence or absence
Measured: intra-operatively
applicability of the intra-operatively cholangiography
yes or no
Measured: intra-operatively
presence of bile duct stones (choledocholithiasis)
yes or no
Measured: intra-operatively
Secondary outcomes (23)
gender
male or female
Measured: pre-operatively
ASA score
number
Measured: pre-operatively
age
years
Measured: pre-operatively
body mass index
kg/m2
Measured: pre-operatively
indication for laparoscopic cholecystectomy
yes or no
Measured: pre-operatively
SGOT
g/dL
Measured: 24 hours prior to surgery and 24 hours after the surgery
SGPT
g/dL
Measured: 24 hours prior to surgery and 24 hours after the surgery
ALP
g/dL
Measured: 24 hours prior to surgery and 24 hours after the surgery
γ-GT
g/dL
Measured: 24 hours prior to surgery and 24 hours after the surgery
total bilirubin
mg/dL
Measured: 24 hours prior to surgery and 24 hours after the surgery
indirect bilirubin
mg/dL
Measured: 24 hours prior to surgery and 24 hours after the surgery
direct bilirubin
mg/dL
Measured: 24 hours prior to surgery and 24 hours after the surgery
PT
seconds
Measured: 24 hours prior to surgery and 24 hours after the surgery
INR
number
Measured: 24 hours prior to surgery and 24 hours after the surgery
aPTT
seconds
Measured: 24 hours prior to surgery and 24 hours after the surgery
urea
mg/dL
Measured: 24 hours prior to surgery and 24 hours after the surgery
creatinine
mg/dL
Measured: 24 hours prior to surgery and 24 hours after the surgery
CRP
mg/L
Measured: 24 hours prior to surgery and 24 hours after the surgery
WBC
mm3/L
Measured: 24 hours prior to surgery and 24 hours after the surgery
ESR
mm
Measured: 24 hours prior to surgery and 24 hours after the surgery
procalcitonin
mg/dL
Measured: 24 hours prior to surgery and 24 hours after the surgery
TNF-a
pg/ml
Measured: 24 hours prior to surgery and 24 hours after the surgery
IL-6
pg/ml
Measured: 24 hours prior to surgery and 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start3 Jan 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic; CholecystectomyStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- George Papanicolaou Hospital
- Responsible party
- Principal investigator, Savvas Simeonidis, Aristotle University Of Thessaloniki
- Investigators
- Savvas Simeonidis, MD, PhD(c), Principal investigator, General Hospital of Thessaloniki "G. Papanikolaou", Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908826
- Sponsor's protocol ID
- 3765/03.02.2020
- Status last verified
- Mar 2022
- First submitted
- 10 May 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Costi R, Gnocchi A, Di Mario F, Sarli L. Diagnosis and management of choledocholithiasis in the golden age of imaging, endoscopy and laparoscopy. World J Gastroenterol. 2014 Oct 7;20(37):13382-401. doi: 10.3748/wjg.v20.i37.13382.
PubMed 25309071Duca S, Bala O, Al-Hajjar N, Lancu C, Puia IC, Munteanu D, Graur F. Laparoscopic cholecystectomy: incidents and complications. A retrospective analysis of 9542 consecutive laparoscopic operations. HPB (Oxford). 2003;5(3):152-8. doi: 10.1080/13651820310015293.
PubMed 18332976Al-Mulhim AA. Current trends in laparoscopic cholecystectomy. J Family Community Med. 1997 Jul;4(2):33-40.
PubMed 23008571Duncan CB, Riall TS. Evidence-based current surgical practice: calculous gallbladder disease. J Gastrointest Surg. 2012 Nov;16(11):2011-25. doi: 10.1007/s11605-012-2024-1. Epub 2012 Sep 18.
PubMed 22986769Alander JT, Kaartinen I, Laakso A, Patila T, Spillmann T, Tuchin VV, Venermo M, Valisuo P. A review of indocyanine green fluorescent imaging in surgery. Int J Biomed Imaging. 2012;2012:940585. doi: 10.1155/2012/940585. Epub 2012 Apr 22.
PubMed 22577366Boni L, David G, Mangano A, Dionigi G, Rausei S, Spampatti S, Cassinotti E, Fingerhut A. Clinical applications of indocyanine green (ICG) enhanced fluorescence in laparoscopic surgery. Surg Endosc. 2015 Jul;29(7):2046-55. doi: 10.1007/s00464-014-3895-x. Epub 2014 Oct 11.
PubMed 25303914Ambe PC, Plambeck J, Fernandez-Jesberg V, Zarras K. The role of indocyanine green fluoroscopy for intraoperative bile duct visualization during laparoscopic cholecystectomy: an observational cohort study in 70 patients. Patient Saf Surg. 2019 Jan 12;13:2. doi: 10.1186/s13037-019-0182-8. eCollection 2019.
PubMed 30651756Chu W, Chennamsetty A, Toroussian R, Lau C. Anaphylactic Shock After Intravenous Administration of Indocyanine Green During Robotic Partial Nephrectomy. Urol Case Rep. 2017 Mar 10;12:37-38. doi: 10.1016/j.eucr.2017.02.006. eCollection 2017 May.
PubMed 28316935Hope-Ross M, Yannuzzi LA, Gragoudas ES, Guyer DR, Slakter JS, Sorenson JA, Krupsky S, Orlock DA, Puliafito CA. Adverse reactions due to indocyanine green. Ophthalmology. 1994 Mar;101(3):529-33. doi: 10.1016/s0161-6420(94)31303-0.
PubMed 8127574Symeonidis S, Mantzoros I, Ioannidis O, Anestiadou E, Koltsida A, Christidis P, Bitsianis S, Karastergiou T, Apostolidis S, Foutsitzis V, Kotidis E, Pramateftakis MG, Angelopoulos S. Comparative Evaluation of Standard Cholangiography, Intravenous, and Intracholecystic Indocyanine Green Fluorescence Cholangiography During Elective Laparoscopic Cholecystectomy: Results of a Three-Arm Randomized Trial. Medicina (Kaunas). 2026 Mar 10;62(3):515. doi: 10.3390/medicina62030515.
PubMed 41901596
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Administration of Indocyanine Green (ICG) for Image-Guided Laparoscopic Cholocystectomy- A Randomized, Controlled, Prospective Trial
- ClinicalTrials.gov ID
- NCT04908826
- Acronym / sponsor ID
- 3765/03.02.2020
- Conditions
- Laparoscopic; Cholecystectomy, Cholelithiasis; Bile Duct, Choledocholithiasis, Stone - Biliary, Post-Op Complication, Cholangiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- George Papanicolaou Hospital
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 1 Jun 2021 (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.
The aim of the trial is to compare the routes of administration of indocyanine green (ICG) during laparoscopic cholocystectomy.
Detailed description
Laparoscopic cholecystectomy is now the method of choice for the treatment of symptomatic and complicated gallstones.
There are two major problems that can occur during and after a laparoscopic cholecystectomy. These are the remaining stones in the bile duct and the iatrogenic injuries of the bile ducts. Iatrogenic bile duct injuries are the most difficult complication of cholecystectomy and are a clinical entity that needs multifactorial treatment as it significantly increases morbidity, mortality and overall cost. Intraoperative cholangiography is used to prevent these complications.
Intraoperative cholangiography is the traditional method of identifying bile duct anatomy during laparoscopic cholecystectomy. This method has the disadvantages that both the patient and the staff are exposed to radiation, while in order to perform it, catheterization of the cystic duct must be performed, which requires surgical procedures that increase the time of the operation, while in some cases it is not technically easy. Finally, with the intraoperative cholangiography, the injuries of the bile ducts are detected, after they have taken place, therefore it helps in their timely diagnosis but does not limit the frequency of their occurrence.
Indocyanine green is a sterile, anionic, water-soluble but relatively hydrophobic tricarbocyanine molecule with a molecular weight of 751.4. It was developed in 1955 at Kodak Laboratories and in 1959 was approved for clinical use by the FDA. It has the property of fluorescing, after its administration, with a maximum absorption at 800 nm after exposure to infrared lighting. Its use offers an image of high clarity and sensitivity, target imaging, with parallel low acoustic emission. Indocyanine green has the following properties and advantages, which make it an important tool in the applications of medical sciences and studies.
Following intravenous administration, it binds to plasma lipoproteins with minimal escape into the interstitial space. Extremely important for its clinical use is the complete excretion through the bile, as well as the non-production of metabolic products. It has low toxicity in the absence of ionization, which in combination with the short half-life of the substance, provides safety for the patient in its use and application in medical and biomedical sciences. It has low costs that in combination with its ease of use facilitates its application. No expensive equipment or large learning curve required. Also the possibility of recurrence with re-administration intraoperatively can offer a number of applications in laparoscopic surgery. It has a low rate of side effects and interactions with other drugs and preparations, a major allergic reaction has been reported in the literature. The first clinical applications of indocyanine green were to assess cardiac function, liver function in cirrhotic patients before hepatectomy, and to examine the retinal vessels.
Its use in laparoscopic cholecystectomy, as already mentioned, is based on its ability to fluoresce when exposed to infrared light and in combination with the fact that when administered intravenously it is concentrated and excreted from the bile offers the possibility of intraoperative, fluorescent cholangiography that aims to identify the elements of the Callot triangle.
This study aims to demonstrate that endocyanin green cholangiography is equivalent to or better than conventional cholangiography for the diagnosis of cholelithiasis and biliary injuries. It is therefore an important clinical application that will probably facilitate surgeons both in the prevention of biliary injuries and in the intraoperative diagnosis of cholelithiasis.
Patients who will undergo laparoscopic cholecystectomy will be randomly divided into 3 (three) groups. The processing of the results will be done in the appropriate way and method. A total of 240 patients will be randomized into three groups of 80. In the first group (A) classical cholangiography will be performed. In group (B) will be performed intravenous fluorescent cholangiography with indocyanine green 6 (six) hours before the start of surgery. In the third group (C) will be performed intraoperative cholangiography with direct administration of indocyanine green to the gallbladder.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (standard cholangiography during surgery) | Active comparator | Procedure: Indocyanine Green (ICG) administrationAll patients will undergo laparoscopic cholecystectomy. In this group standard cholangiography will be performed during surgery. Standard cholangiography will be performed with selective catheterization of the cystic duct and infusion of a radiolucent substance (non-ionic low osmotic iodine). The category includes drugs such as iohexol, iopamidol, iopromide, ioversol, iobitriol, iomeprol and iodixanol. In our study we will use Xenetix (iobitriol) and perform cholangiography with C-ARM recording. |
| Group B (cholangiography with iv administration of icg prior to surgery) | Active comparator | Procedure: Indocyanine Green (ICG) administrationAll patients will undergo laparoscopic cholecystectomy. In this group intravenous fluorescent cholangiography with indocyanine green will be given at a dose of 0.3 mg / mL / Kg 6 (six) hours before the start of surgery.The bile duct system will be recorded with a special camera (Karl Storz NIR / ICG). |
| Group C (cholangiography with direct administration of icg to the bile duct system during surgery) | Active comparator | Procedure: Indocyanine Green (ICG) administrationAll patients will undergo laparoscopic cholecystectomy. In the third group intraoperative cholangiography will be performed with direct administration of indocyanine green at a dose of 0.03 mg / ml / Kg to the bile duct cyst. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age older than 18 years old
- laparoscopic cholecystectomy
- elective surgery
Key exclusion criteria (4 listed)
- younger than 18 years old
- no consent to participate to the study
- history of allergic reaction to iodine products
- urgent or emergent cholecystectomy
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 Green (ICG) administrationAlso: laparoscopic cholecystectomy, intra-operative cholangiography, c-arm recording, iodine solution administrationPatients will undergo laparoscopic cholecystectomy after they are randomly divided into 3 (three) groups. A total of 240 patients will be randomized into three groups of 80. In the first group (A) standard cholangiography will be performed. In group (B) intravenous fluorescent cholangiography with indocyanine green will be performed during surgery. ICG at a dose of 0.3 mg / mL / Kg 6 (six) hours prior to surgery will be administered. In the third group (C), intraoperative cholangiography will be performed with direct administration of indocyanine green at a dose of 0.03 mg / ml / Kg to the gallbladder. | Procedure or surgery | Group A (standard cholangiography during surgery), Group B (cholangiography with iv administration of icg prior to surgery), Group C (cholangiography with direct administration of icg to the bile duct system during surgery) |
Primary outcome
successful imaging of biliary system
Time frame: intra-operatively
The anatomy of the extrahepatic bile ducts will be orally determined by the surgeon and the cases in which the oral description will coincide with the findings of cholangiography or not and where there were differences will be recorded.
operation duration
Time frame: intra-operatively
minutes
intra-operative complications (bleeding, bile duct leakage, bile duct injury)
Time frame: intra-operatively
presence or absence
applicability of the intra-operatively cholangiography
Time frame: intra-operatively
yes or no
presence of bile duct stones (choledocholithiasis)
Time frame: intra-operatively
yes or no
23 secondary outcomes
gender
Time frame: pre-operatively
ASA score
Time frame: pre-operatively
age
Time frame: pre-operatively
body mass index
Time frame: pre-operatively
indication for laparoscopic cholecystectomy
Time frame: pre-operatively
SGOT
Time frame: 24 hours prior to surgery and 24 hours after the surgery
SGPT
Time frame: 24 hours prior to surgery and 24 hours after the surgery
ALP
Time frame: 24 hours prior to surgery and 24 hours after the surgery
γ-GT
Time frame: 24 hours prior to surgery and 24 hours after the surgery
total bilirubin
Time frame: 24 hours prior to surgery and 24 hours after the surgery
indirect bilirubin
Time frame: 24 hours prior to surgery and 24 hours after the surgery
direct bilirubin
Time frame: 24 hours prior to surgery and 24 hours after the surgery
PT
Time frame: 24 hours prior to surgery and 24 hours after the surgery
INR
Time frame: 24 hours prior to surgery and 24 hours after the surgery
aPTT
Time frame: 24 hours prior to surgery and 24 hours after the surgery
urea
Time frame: 24 hours prior to surgery and 24 hours after the surgery
creatinine
Time frame: 24 hours prior to surgery and 24 hours after the surgery
CRP
Time frame: 24 hours prior to surgery and 24 hours after the surgery
WBC
Time frame: 24 hours prior to surgery and 24 hours after the surgery
ESR
Time frame: 24 hours prior to surgery and 24 hours after the surgery
procalcitonin
Time frame: 24 hours prior to surgery and 24 hours after the surgery
TNF-a
Time frame: 24 hours prior to surgery and 24 hours after the surgery
IL-6
Time frame: 24 hours prior to surgery and 24 hours after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 25309071Costi R, Gnocchi A, Di Mario F, Sarli L. Diagnosis and management of choledocholithiasis in the golden age of imaging, endoscopy and laparoscopy. World J Gastroenterol. 2014 Oct 7;20(37):13382-401. doi: 10.3748/wjg.v20.i37.13382.
- Background: PubMed 18332976Duca S, Bala O, Al-Hajjar N, Lancu C, Puia IC, Munteanu D, Graur F. Laparoscopic cholecystectomy: incidents and complications. A retrospective analysis of 9542 consecutive laparoscopic operations. HPB (Oxford). 2003;5(3):152-8. doi: 10.1080/13651820310015293.
- Background: PubMed 23008571Al-Mulhim AA. Current trends in laparoscopic cholecystectomy. J Family Community Med. 1997 Jul;4(2):33-40.
- Background: PubMed 22986769Duncan CB, Riall TS. Evidence-based current surgical practice: calculous gallbladder disease. J Gastrointest Surg. 2012 Nov;16(11):2011-25. doi: 10.1007/s11605-012-2024-1. Epub 2012 Sep 18.
- Background: PubMed 22577366Alander JT, Kaartinen I, Laakso A, Patila T, Spillmann T, Tuchin VV, Venermo M, Valisuo P. A review of indocyanine green fluorescent imaging in surgery. Int J Biomed Imaging. 2012;2012:940585. doi: 10.1155/2012/940585. Epub 2012 Apr 22.
- Background: PubMed 25303914Boni L, David G, Mangano A, Dionigi G, Rausei S, Spampatti S, Cassinotti E, Fingerhut A. Clinical applications of indocyanine green (ICG) enhanced fluorescence in laparoscopic surgery. Surg Endosc. 2015 Jul;29(7):2046-55. doi: 10.1007/s00464-014-3895-x. Epub 2014 Oct 11.
- Background: PubMed 30651756Ambe PC, Plambeck J, Fernandez-Jesberg V, Zarras K. The role of indocyanine green fluoroscopy for intraoperative bile duct visualization during laparoscopic cholecystectomy: an observational cohort study in 70 patients. Patient Saf Surg. 2019 Jan 12;13:2. doi: 10.1186/s13037-019-0182-8. eCollection 2019.
- Background: PubMed 28316935Chu W, Chennamsetty A, Toroussian R, Lau C. Anaphylactic Shock After Intravenous Administration of Indocyanine Green During Robotic Partial Nephrectomy. Urol Case Rep. 2017 Mar 10;12:37-38. doi: 10.1016/j.eucr.2017.02.006. eCollection 2017 May.
- Background: PubMed 8127574Hope-Ross M, Yannuzzi LA, Gragoudas ES, Guyer DR, Slakter JS, Sorenson JA, Krupsky S, Orlock DA, Puliafito CA. Adverse reactions due to indocyanine green. Ophthalmology. 1994 Mar;101(3):529-33. doi: 10.1016/s0161-6420(94)31303-0.
- Derived from this study: PubMed 41901596Symeonidis S, Mantzoros I, Ioannidis O, Anestiadou E, Koltsida A, Christidis P, Bitsianis S, Karastergiou T, Apostolidis S, Foutsitzis V, Kotidis E, Pramateftakis MG, Angelopoulos S. Comparative Evaluation of Standard Cholangiography, Intravenous, and Intracholecystic Indocyanine Green Fluorescence Cholangiography During Elective Laparoscopic Cholecystectomy: Results of a Three-Arm Randomized Trial. Medicina (Kaunas). 2026 Mar 10;62(3):515. doi: 10.3390/medicina62030515.
- Individual participant dataSharing planned: No
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Active, not recruiting
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic
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. This study is not recruiting at the moment.
Savvas Simeonidis, MD, PhD(c) principal investigator
General Hospital of Thessaloniki "G. Papanikolaou", Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green (ICG) administration in people with Laparoscopic; Cholecystectomy and Cholelithiasis; Bile Duct, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Savvas Simeonidis, MD, PhD(c) (698 0309611 ext. 0030, simeonidissavvas@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful imaging of biliary system (time frame: intra-operatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04908826, which also lists 10 linked publications.
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 10 Mar 2022.