Chronic Calculous CholecystitisPhase 4ICGNCT06629415
Using Indocyanine Green (ICG) to Outline Biliary Tree During Laparoscopic Cholecystectomy
A Phase 4 study testing Indocyanine Green and Indocyanine Green Drug in people with Chronic Calculous Cholecystitis and Laparoscopic Cholecystectomy, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
The current study shows that Indocyanine green (ICG)-fluorescence cholangiography can be useful in identifying the extrahepatic biliary anatomy during Calot's triangle dissection. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Chronic Calculous Cholecystitis, Laparoscopic Cholecystectomy
- What is being tested?
- Indocyanine Green and Indocyanine Green Drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2022to 10 May 2024
- Phase
- Phase 4
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of gall bladder pathology (cholecystitis, gall bladder polyp) Patients fit for laparoscopic cholecystectomy.
Who cannot join
- Patients with contraindication for laparoscopic cholecystectomy (for example patients had significant pulmonary or cardiac problems or severe renal insufficiency).
- Proven or suspected allergies to ICG. pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Injection Versus Transhepatic Intracholecystic Injection of Indocyanine Green (ICG) to Outline Biliary Tree During Laparoscopic Cholecystectomy
The current study shows that Indocyanine green (ICG)-fluorescence cholangiography can be useful in identifying the extrahepatic biliary anatomy during Calot's triangle dissection. By avoiding hepatic fluorescence, the transhepatic intracholecystic-ICG route can increase the bile duct-to-liver contrast with less expense and no risk of hypersensitivity reactions than the intravenous ICG injection method. We recommend to use both techniques in case of acute cholecystitis with cystic duct obstruction. In cases of liver cirrhosis, we recommend transhepatic IC-ICG as IV-ICG is limited.
Read the detailed description
Materials and Methods After informed consent, 60 patients with acute or chronic cholecystitis scheduled for NIR-ICG fluorescent cholangiography during LC were consecutively included in the study. ICG was ad ministered intravenously or intracholecystic injection during surgery. This prospective randomized comparative was evaluated based mainly on the clear anatomical delineation of the gall bladder, cystic duct, hepatic ducts and common bile duct. This study had been conducted from 2022 to 2024 with the approval of the institutional ethics committee.
Inclusion criteria included patients from 16 to 80 years old, patients with gall bladder pathology (cholecystitis, gall bladder polyp) and patients fit for laparoscopic cholecystectomy.
Exclusion criteria included patients with contraindication for laparoscopic cholecystectomy (for example patients had significant pulmonary or cardiac problems or severe renal insufficiency), intraoperative dye spillage during dissection of the gallbladder, obstructive jaundice, proven or suspected allergies to ICG, pregnancy or lactation.
The patients were classified into 2 groups, group A patients (n = 30) were chosen for intravenous injection of ICG while group B patients (n = 30) were chosen for transhepatic intracholecystic injection of ICG during cholecystectomy.
To randomise, a sealed opaque envelope was chosen based on a computer-generated random sequence. Surgeons with extensive experience in biliary surgery performed all laparoscopic procedures. The patients age, sex, BMI, comorbidities, and cholecystectomy indication were among their characteristics. Perioperative data included the percentage of non-elective versus elective procedures, the length of time from skin incision to skin closure during the procedure, the location of intraoperative drains, the estimated blood loss (EBL), and the necessity of switching from a laparoscopic to an open approach.
Of note, patients undergoing a concomitant procedure during LC (i.e., esophagogastroduodenoscopy, liver biopsy, lap gastric band removal, etc.) were excluded from the operative time analysis.
A laparoscopic system was used in each and every instance. The image is created by a top-of-the-line full-HD camera system that is mounted to a laparoscope with a 30° field of view and a 10mm diameter. It was equipped with a unique filter for the best detection of NIR fluorescence and white light without the need for manual switching. The strong xenon light source provided excitation light for both the visible and NIR spectrums. The surgeon controled the changeover from conventional light to near-infrared light with a pedal. An expert image improvement system that allowed surgeons to select their preferred adjustable visualization modalities.
Thirty patients received intravenous ICG in group A (IV-ICG). In order to administer ICG, the standard protocol called for injecting 7.5 mg (3 ml of a 25 mg/10 ml solution) intravenously in the pre-operative holding area at least 20 minutes before surgery. Just before injection, a 25 mg vial of Indocyanine Green for Injection.
Before dissecting the adhesions surrounding the hepatoduodenal ligament, fluorescence cholangiography (FC) is carried out to determine the anatomy of the extrahepatic bile ducts by converting the full-color images to fluorescence images using filter switches on the camera head and/or light source in the laparoscopic imaging system. The "critical view of safety" was then reached by dissecting Calot's triangle and using FC to verify whether the accessory bile ducts are present or absent throughout the procedures. It was necessary to acquire fluorescence images of the bile ducts from both the ventral and dorsal sides of Calot's triangle. After confirming that there were no fluorescing structures other than the cystic duct (CD) connecting the gallbladder and the common hepatic duct (CHD), the CD was finally closed and divided.
In group B (IC-ICG): Transhepatic intracholecystic injection of ICG was done in 30 patients. 1.25 mg of ICG powder from a 25 mg ICG vial were separated under aseptic conditions and dissolved in 3 ml of saline, and the concentration was roughly 0.04 mg after each 1 ml was diluted by 9 ml of saline. In order to prevent dye leakage that might result in false FC results, a veress needle was inserted through the abdominal wall and into the gall bladder fundus through the liver parenchyma (transhepatic), Then puncture site was cauterized. Then the same technique and images were taken as in group A.
Usually, the gallbladder was removed through the umbilical or epigastric port. From the moment the first incision was made until the last wound was closed, the operating time was tracked. On the first postoperative day, patients were sent home. An analysis was conducted on the following factors: operation time, dye spillage due to technique due to injection, cystic duct, common hepatic duct, common bile duct delineation, drain insertion, postoperative hospital stays, complications, and biliary injury.
Statistical methods Student\'s t test was used to compare the data with a normal distribution and the continuous variable data, which were provided as mean ± standard deviation. When appropriate, the Fisher\'s exact test or the Chi-square test were used to compare categorical variables, and logistic regression was employed for univariate analysis. SPSS version 20.0 was used for the statistical analysis (SPSS Inc., Chicago, IL, USA). P values less than 0.05 were regarded as statistically significant.
- Being tested
- Indocyanine Green, Indocyanine Green Drug
- Keywords
- common bile duct injury, Intracholecystic, fluorescence cholangiography, indocyanine green, laparoscopic cholecystectomy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
injecting 7.5 mg (3 ml of a 25 mg/10 ml solution) intravenously in the pre-operative holding area at least 20 minutes before surgery.
Before dissecting the adhesions surrounding the hepatoduodenal ligament, fluorescence cholangiography (FC) is carried out to determine the anatomy of the extrahepatic bile ducts by converting the full-color images to fluorescence images using filter switches on the camera head and/or light source in the laparoscopic imaging system (Fig. 1). The \"critical view of safety\" is then reached by dissecting Calot\'s triangle and using FC to verify whether the accessory bile ducts are present or absent throughout the procedures. It is necessary to acquire fluorescence image
Indocyanine Green DrugDrug
1.25 mg of ICG powder was dissolved in 3 cm of saline, and the concentration was roughly 0.04 mg after each 1 cm of saline was diluted by 9 cm of saline. In order to prevent dye leakage that might result in false FC results, a veress needle was inserted through the abdominal wall and into the gall bladder fundus through the liver bed. The puncture site was then cauterized.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Injection Injection of Indocyanine Green (ICG) | Active comparator | 7.5 mg (3 ml of a 25 mg/10 ml solution) of indocyanine green was injected intravenously in the pre-operative holding area at least 20 minutes before surgery to outline the biliary tree during laparoscopic cholecystectomy. Receives: Drug: Indocyanine Green |
| Transhepatic intracholecystic injection of Indocyanine Green (ICG) | Active comparator | Intracholecystic injection of ICG was done in 30 patients. Twenty 1.25 mg particles, one from a 25 mg ICG vial, were separated under aseptic conditions. Receives: Drug: Indocyanine Green Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of better delineation of the biliary tree during laparoscopic cholecystectomy
To detect the safety, efficacy, feasibility and accuracy in defining the biliary anatomy during laparoscopic cholecystectomy.
Measured: intraoperative and 2 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start5 May 2022
- Primary completion10 May 2023
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Calculous CholecystitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Rady, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629415
- Sponsor's protocol ID
- PT (657)
- Acronym
- ICG
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: the data will be shared upon request from the principle investigator
Publications
van Manen L, Handgraaf HJM, Diana M, Dijkstra J, Ishizawa T, Vahrmeijer AL, Mieog JSD. A practical guide for the use of indocyanine green and methylene blue in fluorescence-guided abdominal surgery. J Surg Oncol. 2018 Aug;118(2):283-300. doi: 10.1002/jso.25105. Epub 2018 Jun 24.
PubMed 29938401
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Injection Versus Transhepatic Intracholecystic Injection of Indocyanine Green (ICG) to Outline Biliary Tree During Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06629415
- Acronym / sponsor ID
- ICG / PT (657)
- Keywords
- common bile duct injury, Intracholecystic, fluorescence cholangiography, indocyanine green, laparoscopic cholecystectomy.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 8 Oct 2024 (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 current study shows that Indocyanine green (ICG)-fluorescence cholangiography can be useful in identifying the extrahepatic biliary anatomy during Calot's triangle dissection. By avoiding hepatic fluorescence, the transhepatic intracholecystic-ICG route can increase the bile duct-to-liver contrast with less expense and no risk of hypersensitivity reactions than the intravenous ICG injection method. We recommend to use both techniques in case of acute cholecystitis with cystic duct obstruction. In cases of liver cirrhosis, we recommend transhepatic IC-ICG as IV-ICG is limited.
Detailed description
Materials and Methods After informed consent, 60 patients with acute or chronic cholecystitis scheduled for NIR-ICG fluorescent cholangiography during LC were consecutively included in the study. ICG was ad ministered intravenously or intracholecystic injection during surgery. This prospective randomized comparative was evaluated based mainly on the clear anatomical delineation of the gall bladder, cystic duct, hepatic ducts and common bile duct. This study had been conducted from 2022 to 2024 with the approval of the institutional ethics committee.
Inclusion criteria included patients from 16 to 80 years old, patients with gall bladder pathology (cholecystitis, gall bladder polyp) and patients fit for laparoscopic cholecystectomy.
Exclusion criteria included patients with contraindication for laparoscopic cholecystectomy (for example patients had significant pulmonary or cardiac problems or severe renal insufficiency), intraoperative dye spillage during dissection of the gallbladder, obstructive jaundice, proven or suspected allergies to ICG, pregnancy or lactation.
The patients were classified into 2 groups, group A patients (n = 30) were chosen for intravenous injection of ICG while group B patients (n = 30) were chosen for transhepatic intracholecystic injection of ICG during cholecystectomy.
To randomise, a sealed opaque envelope was chosen based on a computer-generated random sequence. Surgeons with extensive experience in biliary surgery performed all laparoscopic procedures. The patients age, sex, BMI, comorbidities, and cholecystectomy indication were among their characteristics. Perioperative data included the percentage of non-elective versus elective procedures, the length of time from skin incision to skin closure during the procedure, the location of intraoperative drains, the estimated blood loss (EBL), and the necessity of switching from a laparoscopic to an open approach.
Of note, patients undergoing a concomitant procedure during LC (i.e., esophagogastroduodenoscopy, liver biopsy, lap gastric band removal, etc.) were excluded from the operative time analysis.
A laparoscopic system was used in each and every instance. The image is created by a top-of-the-line full-HD camera system that is mounted to a laparoscope with a 30° field of view and a 10mm diameter. It was equipped with a unique filter for the best detection of NIR fluorescence and white light without the need for manual switching. The strong xenon light source provided excitation light for both the visible and NIR spectrums. The surgeon controled the changeover from conventional light to near-infrared light with a pedal. An expert image improvement system that allowed surgeons to select their preferred adjustable visualization modalities.
Thirty patients received intravenous ICG in group A (IV-ICG). In order to administer ICG, the standard protocol called for injecting 7.5 mg (3 ml of a 25 mg/10 ml solution) intravenously in the pre-operative holding area at least 20 minutes before surgery. Just before injection, a 25 mg vial of Indocyanine Green for Injection.
Before dissecting the adhesions surrounding the hepatoduodenal ligament, fluorescence cholangiography (FC) is carried out to determine the anatomy of the extrahepatic bile ducts by converting the full-color images to fluorescence images using filter switches on the camera head and/or light source in the laparoscopic imaging system. The "critical view of safety" was then reached by dissecting Calot's triangle and using FC to verify whether the accessory bile ducts are present or absent throughout the procedures. It was necessary to acquire fluorescence images of the bile ducts from both the ventral and dorsal sides of Calot's triangle. After confirming that there were no fluorescing structures other than the cystic duct (CD) connecting the gallbladder and the common hepatic duct (CHD), the CD was finally closed and divided.
In group B (IC-ICG): Transhepatic intracholecystic injection of ICG was done in 30 patients. 1.25 mg of ICG powder from a 25 mg ICG vial were separated under aseptic conditions and dissolved in 3 ml of saline, and the concentration was roughly 0.04 mg after each 1 ml was diluted by 9 ml of saline. In order to prevent dye leakage that might result in false FC results, a veress needle was inserted through the abdominal wall and into the gall bladder fundus through the liver parenchyma (transhepatic), Then puncture site was cauterized. Then the same technique and images were taken as in group A.
Usually, the gallbladder was removed through the umbilical or epigastric port. From the moment the first incision was made until the last wound was closed, the operating time was tracked. On the first postoperative day, patients were sent home. An analysis was conducted on the following factors: operation time, dye spillage due to technique due to injection, cystic duct, common hepatic duct, common bile duct delineation, drain insertion, postoperative hospital stays, complications, and biliary injury.
Statistical methods Student\'s t test was used to compare the data with a normal distribution and the continuous variable data, which were provided as mean ± standard deviation. When appropriate, the Fisher\'s exact test or the Chi-square test were used to compare categorical variables, and logistic regression was employed for univariate analysis. SPSS version 20.0 was used for the statistical analysis (SPSS Inc., Chicago, IL, USA). P values less than 0.05 were regarded as statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Injection Injection of Indocyanine Green (ICG) | Active comparator | Drug: Indocyanine Green7.5 mg (3 ml of a 25 mg/10 ml solution) of indocyanine green was injected intravenously in the pre-operative holding area at least 20 minutes before surgery to outline the biliary tree during laparoscopic cholecystectomy. |
| Transhepatic intracholecystic injection of Indocyanine Green (ICG) | Active comparator | Drug: Indocyanine Green DrugIntracholecystic injection of ICG was done in 30 patients. Twenty 1.25 mg particles, one from a 25 mg ICG vial, were separated under aseptic conditions. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of gall bladder pathology (cholecystitis, gall bladder polyp) Patients fit for laparoscopic cholecystectomy.
Key exclusion criteria (2 listed)
- Patients with contraindication for laparoscopic cholecystectomy (for example patients had significant pulmonary or cardiac problems or severe renal insufficiency).
- Proven or suspected allergies to ICG. pregnancy or lactation.
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 Greeninjecting 7.5 mg (3 ml of a 25 mg/10 ml solution) intravenously in the pre-operative holding area at least 20 minutes before surgery. Before dissecting the adhesions surrounding the hepatoduodenal ligament, fluorescence cholangiography (FC) is carried out to determine the anatomy of the extrahepatic bile ducts by converting the full-color images to fluorescence images using filter switches on the camera head and/or light source in the laparoscopic imaging system (Fig. 1). The \"critical view of safety\" is then reached by dissecting Calot\'s triangle and using FC to verify whether the accessory bile ducts are present or absent throughout the procedures. It is necessary to acquire fluorescence image | Drug | Intravenous Injection Injection of Indocyanine Green (ICG) |
| Indocyanine Green Drug1.25 mg of ICG powder was dissolved in 3 cm of saline, and the concentration was roughly 0.04 mg after each 1 cm of saline was diluted by 9 cm of saline. In order to prevent dye leakage that might result in false FC results, a veress needle was inserted through the abdominal wall and into the gall bladder fundus through the liver bed. The puncture site was then cauterized. | Drug | Transhepatic intracholecystic injection of Indocyanine Green (ICG) |
Primary outcome
The rate of better delineation of the biliary tree during laparoscopic cholecystectomy
Time frame: intraoperative and 2 weeks postoperative
To detect the safety, efficacy, feasibility and accuracy in defining the biliary anatomy during laparoscopic cholecystectomy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 29938401van Manen L, Handgraaf HJM, Diana M, Dijkstra J, Ishizawa T, Vahrmeijer AL, Mieog JSD. A practical guide for the use of indocyanine green and methylene blue in fluorescence-guided abdominal surgery. J Surg Oncol. 2018 Aug;118(2):283-300. doi: 10.1002/jso.25105. Epub 2018 Jun 24.
- Individual participant dataSharing planned: No. the data will be shared upon request from the principle investigator
Related trials for Chronic Calculous Cholecystitis
Enrolling by invitationObservational study
Shortwave Infrared Surgical Imaging Device Study
Cholecystitis, Cholecystitis, Chronic
Not yet recruiting
Probiotic Yogurt in Patients With Chronic Cholecystitis
Chronic Cholecystitis
RecruitingPhase 1
Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers
Chronic Cholecystitis, Biliary Dyskinesia
RecruitingPhase 3
Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Chronic Cholecystitis and Biliary Dyskinesia
Chronic Cholecystitis, Biliary Dyskinesia
RecruitingPhase 2
Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia
Chronic Cholecystitis, Biliary Dyskinesia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indocyanine Green and Indocyanine Green Drug in people with Chronic Calculous Cholecystitis and Laparoscopic Cholecystectomy, run by Theodor Bilharz Research Institute at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 8 Oct 2024. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of better delineation of the biliary tree during laparoscopic cholecystectomy (time frame: intraoperative and 2 weeks postoperative). 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 NCT06629415, which also lists 1 linked publication.
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 8 Oct 2024.