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Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

Primary Purpose

Cholecystitis, Chronic Calculous Cholecystitis, Acute Calculous Cholecystitis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Indocyanine Green Fluorescent Laparoscopic Cholangiography

White Light

About this trial

This is an interventional diagnostic trial for Cholecystitis focused on measuring Laparoscopic Cholecystectomy, Indocyanine Green Fluorescent Cholangiography, Indocyanine Green Fluorescent Angiography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ain Shams University Hospitals - AUSH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NIR/ICG Arm

WL Arm

Arm Description

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography will be done during the Laparoscopic Cholecystectomy

Conventional white light was used for Laparoscopic Cholecystectomy

Outcomes

Primary Outcome Measures

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.

Visual identification of the cystic artery

To measure the % of patients in which investigators can identify visually the cystic artery, during LC.

Secondary Outcome Measures

Visual identification of injuries

To detect of incidence rate of biliary or vascular injury, visually or clinically, resulted from miss identification of the structures.

Compare operative time

To compare the operative time in (minutes)

Compare blood loss

To compare the operative blood loss (in cc)

Compare blood loss in cc

To compare the blood loss (in cc) between the two groups.

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..)

Full Information

NCT ID

NCT05125653

First Posted

October 4, 2021

Last Updated

November 18, 2021

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT05125653

Brief Title

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

July 1, 2021 (Actual)

Study Completion Date

July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholecystitis, Chronic Calculous Cholecystitis, Acute Calculous Cholecystitis

Keywords

Laparoscopic Cholecystectomy, Indocyanine Green Fluorescent Cholangiography, Indocyanine Green Fluorescent Angiography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

2 arms, randomized, double blinded

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NIR/ICG Arm

Arm Type

Experimental

Arm Description

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography will be done during the Laparoscopic Cholecystectomy

Arm Title

WL Arm

Arm Type

Active Comparator

Arm Description

Conventional white light was used for Laparoscopic Cholecystectomy

Intervention Type

Procedure

Intervention Name(s)

Indocyanine Green Fluorescent Laparoscopic Cholangiography

Other Intervention Name(s)

Indocyanine Green Fluorescent LaparoscopicCholangiography

Intervention Description

Indocyanine Green Fluorescent Cholangiography

Intervention Type

Procedure

Intervention Name(s)

White Light

Other Intervention Name(s)

Intervention Description

Performing the laparoscopic cholecystectomy and identifying the biliary structures under the conventional white light

Primary Outcome Measure Information:

Title

Visual identification of the biliary tree

Description

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.

Time Frame

during the procedure

Title

Visual identification of the cystic artery

Description

To measure the % of patients in which investigators can identify visually the cystic artery, during LC.

Time Frame

during the procedure

Secondary Outcome Measure Information:

Title

Visual identification of injuries

Description

To detect of incidence rate of biliary or vascular injury, visually or clinically, resulted from miss identification of the structures.

Time Frame

during and imediatly after the procedure (24 hours)

Title

Compare operative time

Description

To compare the operative time in (minutes)

Time Frame

during the procedure

Title

Compare blood loss

Description

To compare the operative blood loss (in cc)

Time Frame

during the procedure

Title

Compare blood loss in cc

Description

To compare the blood loss (in cc) between the two groups.

Time Frame

during the procedure

Title

Percentage of patients of ICG adverse reactions

Description

To measure % of patients suffering off reactions related to the use of ICG (by vital data assessment, monitor patients' complaints, etc..)

Time Frame

Within 24 hour of the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

M Abd-erRazik, MD

Organizational Affiliation

Ain Shams University

Official's Role

Study Chair

Facility Information:

Facility Name

Ain Shams University Hospitals - AUSH

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

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