Ignite Creation Date:
2024-05-06 @ 1:21 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04005898
Status:
UNKNOWN
Last Update Posted:
2019-07-02
First Post:
2019-06-30
Brief Title:
NIR Fluorescence Cholangiography With Low Dose of ICG
Sponsor:
Hospital Son Espases
Organization:
Hospital Son Espases
Study Overview
Official Title:
Near-infrared Incisionless Fluorescent Cholangiography With Low Dose of ICG
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this clinical trial is to visualize the bile ducts by injecting a contrast that is only visible with infrared light For this we administrate an intravenous low dose of ICG before a cholecystectomy
During the intervention the tissue will be exposed to infrared light to visualize the bile ducts This technique aims to increase safety in surgery to avoid damaging bile or vascular structures during gallbladder interventions
During the intervention the tissue will be exposed to infrared light to visualize the bile ducts This technique aims to increase safety in surgery to avoid damaging bile or vascular structures during gallbladder interventions
Detailed Description:
Laparoscopic cholecystectomy is one of the most commonly performed procedures in adult surgery A rare but serious complication of laparoscopic cholecystectomy is bile duct injury with a reported incidence of 03-15 Bile duct injury is often caused by misinterpretation of the anatomical structures rather than by insufficient technical skills Generally bile duct injury leads to bile leakage causing abdominal sepsis It can also lead to obstruction with obstructive jaundice eventually potentially leading to a need for liver transplantation in the worst case Late recognition is common in bile duct injuries resulting in significant morbidity and mortality a lower quality of life and extra costs A recent expert consensus report identified establishment of the critical view of safety as the single most important factor for overall safety during laparoscopic cholecystectomy However evidence suggests that surgeons may actually achieve this view far less often than they believe
Numerous intraoperative visualization techniques and technologies have been developed to enhance the safety of laparoscopic cholecystectomy There are mainly two intraoperative imaging techniques to consider first the historical X-ray-based intraoperative cholangiography and secondly the emerging fluorescence-based intraoperative near-infrared cholangiography Large retrospective and prospective studies have looked at the benefit of routine intraoperative radiographic cholangiography for detection of common bile duct stones and to identify or prevent bile duct injury Whether this procedure should be performed routinely is still an active subject of debate as systematic reviews are inconclusive however several of the larger retrospective studies observed a decrease in frequency and severity of bile duct injury when intraoperative cholangiography is performed Limiting factors for performing radiographic laparoscopic cholangiography include it requires specific expertise in the technique and its interpretation it involves the use of ionizing radiation it is time-consuming and it creates a risk for bile leakage and duct injury itself since puncturing and cannulation of the cystic duct is required These limitations justify the quest for alternative less complicated techniques to visualize biliary anatomy during cholecystectomy Fluorescence-based intraoperative near-infrared cholangiography during laparoscopic cholecystectomy has been introduced by Ishizawa et al in recent years as a non-invasive radiation-free low-cost alternative for realtime visualization of the biliary anatomy This technique requires near-infrared laparoscopic imaging systems as well as the intravenous injection of a fluorophore ie indocyanine green which is eliminated through the biliary tree Following exposure to the near-infrared fluorescenc light source indocyanine green becomes fluorescent and highlights relevant biliary structures Since the pioneer studies a large number of trials have been conducted and several protocols are currently underway in order to establish the clinical efficacy of near-infrared cholangiography A recent systematic review of clinical studies on near-infrared cholangiography has reported high visualization rates of biliary structures as a surrogate marker of clinical efficacy before dissection of Calots triangle However one of the most significant drawbacks of near-infrared cholangiography following systemic indocyanine green injection lies in the very high background signal due to the rapid accumulation of indocyanine green in the liver which can impair the visualization of the biliary structures The keys to avoiding this inconvenience are the dose of indocyanin green and the time of administration before the surgical procedure So far studies used a dose of indocyanin green above 25mg To avoid this effect at these doses the authors administer the contrast many minutes or even hours before starting the surgical procedure
Numerous intraoperative visualization techniques and technologies have been developed to enhance the safety of laparoscopic cholecystectomy There are mainly two intraoperative imaging techniques to consider first the historical X-ray-based intraoperative cholangiography and secondly the emerging fluorescence-based intraoperative near-infrared cholangiography Large retrospective and prospective studies have looked at the benefit of routine intraoperative radiographic cholangiography for detection of common bile duct stones and to identify or prevent bile duct injury Whether this procedure should be performed routinely is still an active subject of debate as systematic reviews are inconclusive however several of the larger retrospective studies observed a decrease in frequency and severity of bile duct injury when intraoperative cholangiography is performed Limiting factors for performing radiographic laparoscopic cholangiography include it requires specific expertise in the technique and its interpretation it involves the use of ionizing radiation it is time-consuming and it creates a risk for bile leakage and duct injury itself since puncturing and cannulation of the cystic duct is required These limitations justify the quest for alternative less complicated techniques to visualize biliary anatomy during cholecystectomy Fluorescence-based intraoperative near-infrared cholangiography during laparoscopic cholecystectomy has been introduced by Ishizawa et al in recent years as a non-invasive radiation-free low-cost alternative for realtime visualization of the biliary anatomy This technique requires near-infrared laparoscopic imaging systems as well as the intravenous injection of a fluorophore ie indocyanine green which is eliminated through the biliary tree Following exposure to the near-infrared fluorescenc light source indocyanine green becomes fluorescent and highlights relevant biliary structures Since the pioneer studies a large number of trials have been conducted and several protocols are currently underway in order to establish the clinical efficacy of near-infrared cholangiography A recent systematic review of clinical studies on near-infrared cholangiography has reported high visualization rates of biliary structures as a surrogate marker of clinical efficacy before dissection of Calots triangle However one of the most significant drawbacks of near-infrared cholangiography following systemic indocyanine green injection lies in the very high background signal due to the rapid accumulation of indocyanine green in the liver which can impair the visualization of the biliary structures The keys to avoiding this inconvenience are the dose of indocyanin green and the time of administration before the surgical procedure So far studies used a dose of indocyanin green above 25mg To avoid this effect at these doses the authors administer the contrast many minutes or even hours before starting the surgical procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None