Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

Cholecystitis Clinical Trial

Official title:

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy, a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05125653
• Other study ID #: AinShamsSurg2
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: November 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy

Description:

A double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy in Ain-Shams University Specialized Hospital in the period from January 2020 till July 2021. Group A (n=60) underwent laparoscopic cholecystectomy using the usual white light, Group B (n=58) underwent laparoscopic cholecystectomy with ICG florescence cholangiography and intraoperative ICG florescence arteriography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adults (from 18 to 75 years old)

• suffering from a gall bladder disease

• with valid indication for laparoscopic cholecystectomy (e.g., calculus gall bladder with cholecystitis)

• accepted to participate in the study.

Exclusion Criteria:

• Patients with history of previous biliary surgery

• Patients with abdominal malignancy

• Patients with advanced chronic liver disease

• pregnant women

Related Conditions & MeSH terms

• Acute Calculous Cholecystitis
• Cholecystitis
• Cholecystitis, Acute
• Chronic Calculous Cholecystitis

Intervention

Procedure:
• Indocyanine Green Fluorescent Laparoscopic Cholangiography
Indocyanine Green Fluorescent Cholangiography
• White Light
Performing the laparoscopic cholecystectomy and identifying the biliary structures under the conventional white light

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals - AUSH	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual identification of the biliary tree	To measure the % of patients in which investigators can identify visually the extra hepatic biliary system (the CD, CBD, CHD, and any possible anomalies present), during LC.	during the procedure
Primary	Visual identification of the cystic artery	To measure the % of patients in which investigators can identify visually the cystic artery, during LC.	during the procedure
Secondary	Visual identification of injuries	To detect of incidence rate of biliary or vascular injury, visually or clinically, resulted from miss identification of the structures.	during and imediatly after the procedure (24 hours)
Secondary	Compare operative time	To compare the operative time in (minutes)	during the procedure
Secondary	Compare blood loss	To compare the operative blood loss (in cc)	during the procedure
Secondary	Compare blood loss in cc	To compare the blood loss (in cc) between the two groups.	during the procedure
Secondary	Percentage of patients of ICG adverse reactions	To measure % of patients suffering off reactions related to the use of ICG (by vital data assessment, monitor patients' complaints, etc..)	Within 24 hour of the procedure