Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573021
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Fluorescent Cholangiography in Acute Cholecystitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of Fluorescent Cholangiography to Improve Operative Safety in Different Severity Degree of Acute Cholecystitis During Emergency Laparoscopic Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2024-08
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:
None
Brief Summary:
Currently there is limited scientific evidence regarding the effectiveness of fluorescent cholangiography in emergency cholecystectomy for acute cholecystitis The primary aim of this study was to assess the efficacy of near-infrared fluorescent cholangiography to detect extrahepatic biliary anatomy in different severity degrees of acute cholecystitis
Detailed Description:
The study aims to to evaluate the efficacy of near-infrared fluorescent cholangiography for real-time visualization of the extrahepatic biliary tree cystic duct common hepatic duct cystic duct-common hepatic duct junction common bile duct and any accessory or aberrant ducts in emergency laparoscopic cholecystectomy before and after hepatocystic triangle dissection and in different degrees of severity of acute cholecystitis according to the American Association of Surgery for Trauma AAST classification specifically distinguishing between non-gangrenous grade I and gangrenous or complicated grades II-V forms For intra-operative fluorescent cholangiography 25 mg indocyanine green ICG was administered intravenously 45-60 min prior to surgery according to the recent guidelines from the International Society for Fluorescence Guided Surgery All the operations were performed by the same team of surgeons Near-infrared fluorescent cholangiography was performed by using Strykers fluorescence imaging system Stryker Portage Miami USA Near-infrared fluorescent cholangiography was performed at three defined time point during laparoscopic cholecystectomy i following exposure of Calots triangle prior to any dissection ii after partial dissection of Calots triangle iii after complete dissection of Calots triangle according to the Critical View of Safety method
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