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Completed

NCT Number: NCT05125653

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

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

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Key information

Conditions

Cholecystitis Acute Calculous Cholecystitis Biliary Tract Diseases Cholecystitis, Acute Chronic Calculous Cholecystitis Digestive System Diseases Gallbladder Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals - AUSH

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine Green Fluorescent Laparoscopic Cholangiography

Procedure

Indocyanine Green Fluorescent Cholangiography

Other names: Indocyanine Green Fluorescent LaparoscopicCholangiography

White Light

Procedure

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

Other names: WL

Primary outcomes

  1. Visual identification of the biliary tree

    Time frame: during the procedure

    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.

  2. Visual identification of the cystic artery

    Time frame: during the procedure

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

Secondary outcomes

  1. Visual identification of injuries

    Time frame: during and imediatly after the procedure (24 hours)

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

  2. Compare operative time

    Time frame: during the procedure

    To compare the operative time in (minutes)

  3. Compare blood loss

    Time frame: during the procedure

    To compare the operative blood loss (in cc)

  4. Compare blood loss in cc

    Time frame: during the procedure

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

  5. Percentage of patients of ICG adverse reactions

    Time frame: Within 24 hour of the procedure

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2021
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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