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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05125653
Other study ID # AinShamsSurg2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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