Brief Title
Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis
Official Title
Role of Indocyanine Green in Visualizing Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis
Brief Summary
The purpose of this prospective randomized trial is to study the role of Indocyanine green
(ICG) to visualize the Critical View of Safety during emergency Laparoscopic Cholecystectomy
for patients with Acute Cholecystitis.
Detailed Description
After informing about the study and obtaining consent to participate, patients who are
diagnosed with Acute Cholecystitis and posted for emergency Laparoscopic Cholecystectomy will
be randomly assigned to receive either ICG or not as a method to identify the Critical View
of Safety during the operation.
The primary outcome is whether there was a precise and satisfactory visualization of the
junction between the cystic duct, the common hepatic duct, and the common bile duct by
indocyanine green compared to the control group. The time taken to achieve this will be
measured in minutes from video recordings of the laparoscopic surgery. The process will be
further assessed by a surgeons' satisfaction score.
The expected duration of the study will be 12 months involving a total of 80 patients
randomized into two groups- 40 patients in the intervention group and 40 patients in the
control group.
The expected outcome of the study is that ICG is more effective than the control group in
providing precise and satisfactory visualization of Critical View of Safety and takes less
time. We predict the surgeons to be equally or more satisfied with ICG compared to control.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of surgeries in which Critical View of Safety was achieved
Secondary Outcome
Time taken to identify Critical View of Safety
Condition
Acute Cholecystitis
Intervention
Indocyanine Green
Study Arms / Comparison Groups
ICG group
Description: Participants receive an intravenous injection of 0.05 mg/kg of ICG 45 minutes preoperatively. A Pinpoint Endoscopic Fluorescence System (Novadac Technologies Inc., Canada) for ICG Fluorescence Observation with the easy switchable white light-fluorescent mode is used. Before dividing any tubular structure, the fluorescence imaging mode is routinely used again, and fluorescent angiography is performed by re-injecting the same dose of ICG as initially used. After the division of the cystic duct and artery, the fluorescence imaging mode is applied again to check for bile leakage.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
80
Start Date
January 1, 2021
Completion Date
January 15, 2022
Primary Completion Date
December 31, 2021
Eligibility Criteria
Inclusion Criteria:
- Patient scheduled for emergency Laparoscopic Cholecystectomy for Acute Cholecystitis
- Patient age ≥ 18 years.
- Patients who consent to take part in the study
Exclusion Criteria:
- Preoperative planned for Open Cholecystectomy
- Allergy towards iodine, iohexol or ICG
- Pregnancy or lactation
- Renal insufficiency
- Legally incompetent for any reason
- Withdrawal of inclusion consent at any time
- Prisoners
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Zia Aftab, MBBS, FACS, 00974-66233904, [email protected]
Location Countries
Qatar
Location Countries
Qatar
Administrative Informations
NCT ID
NCT04624841
Organization ID
IRGC-05-NI-18-362
Secondary IDs
U1111-1256-1361
Responsible Party
Principal Investigator
Study Sponsor
Hamad Medical Corporation
Study Sponsor
Zia Aftab, MBBS, FACS, Principal Investigator, Hamad Medical Corporation
Verification Date
December 2020