Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy

Detailed Description
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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.

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

Conditions
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Cholecystitis, Chronic Calculous Cholecystitis, Acute Calculous Cholecystitis

Intervention / Treatment
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* Procedure: Indocyanine Green Fluorescent Laparoscopic Cholangiography
* Procedure: White Light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arms, randomized, double blinded
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIR/ICG Arm<br>Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography will be done during the Laparoscopic Cholecystectomy | Procedure: Indocyanine Green Fluorescent Laparoscopic Cholangiography<br>* Indocyanine Green Fluorescent Cholangiography<br>* Other names: Indocyanine Green Fluorescent LaparoscopicCholangiography;|
| Active Comparator: WL Arm<br>Conventional white light was used for Laparoscopic Cholecystectomy | Procedure: White Light<br>* Performing the laparoscopic cholecystectomy and identifying the biliary structures under the conventional white light<br>* Other names: WL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Compare operative time | To compare the operative time in (minutes) | during the procedure | 
| Compare blood loss | To compare the operative blood loss (in cc) | during the procedure | 
| Compare blood loss in cc | To compare the blood loss (in cc) between the two groups. | during the procedure | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Cholecystectomy, Indocyanine Green Fluorescent Cholangiography, Indocyanine Green Fluorescent Angiography