Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629415
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Using Indocyanine Green ICG to Outline Biliary Tree During Laparoscopic Cholecystectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intravenous Injection Versus Transhepatic Intracholecystic Injection of Indocyanine Green ICG to Outline Biliary Tree During Laparoscopic Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICG
Brief Summary:
The current study shows that Indocyanine green ICG-fluorescence cholangiography can be useful in identifying the extrahepatic biliary anatomy during Calots 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 ie 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 75 mg 3 ml of a 25 mg10 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 andor light source in the laparoscopic imaging system The critical view of safety was then reached by dissecting Calots 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 Calots 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 125 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 004 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 Student39s 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 Fisher39s exact test or the Chi-square test were used to compare categorical variables and logistic regression was employed for univariate analysis SPSS version 200 was used for the statistical analysis SPSS Inc Chicago IL USA P values less than 005 were regarded as statistically significant
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 ie 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 75 mg 3 ml of a 25 mg10 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 andor light source in the laparoscopic imaging system The critical view of safety was then reached by dissecting Calots 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 Calots 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 125 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 004 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 Student39s 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 Fisher39s exact test or the Chi-square test were used to compare categorical variables and logistic regression was employed for univariate analysis SPSS version 200 was used for the statistical analysis SPSS Inc Chicago IL USA P values less than 005 were regarded as statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None