Acute Cholecystitis, Acute; Cholecystitis, Choledocholithiasis, Acute Cholecystitis With Obstruction
Conditions
Keywords
acute cholecystitis, laparoscopic cholecystectomy, critical view of safety, safe cholecystectomy, indocyanine green, operative cholangiogram, fluorescent imaging, near-infrared imaging
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.
Interventions
DRUGIndocyanine Green
2.5-7.5 mg (0.05 mg/kg) injection
Sponsors
Hamad Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patient is blinded to the intervention S/he receives. The surgeon, investigator, and outcomes assessor are masked but not strictly blinded up to the point when the near-infrared camera is switched on
Intervention model description
Prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of surgeries in which Critical View of Safety was achieved | Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open. | Percentage of surgeries where there was complete visualization of Critical View of Safety by intraoperative fluorescent cholangiography compared to the control group with no fluorescent imaging. Complete visualization of the Critical View of Safety is defined by the SAGS guidelines. The laparoscopic procedure is recorded & assessed individually & separately by two consultant surgeons who are not the operating surgeon whether the Critical View of Safety was achieved prior to clipping of Cystic Duct & Cystic Artery. Failure of identification of Critical View of Safety is defined as the need for further conventional intraoperative cholangiography or open conversion due to inability to accurately identify the biliary anatomy to complete the cholecystectomy safely. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time taken to identify Critical View of Safety | After securing working ports till Clipping of Cystic Duct or Artery. | Time taken by intraoperative fluorescent cholangiography or control group to identify Critical View of Safety. The laparoscopic procedure is recorded and Time taken is recorded by the Primary Investigator as the total time between successful introduction of the operative ports until the Critical View of Safety is achieved and Cystic Duct and Cystic Artery are clipped. |
| Surgeon's Satisfaction Survey | Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open. | Surgeon satisfaction survey will be completed by the operating surgeon intraoperatively by answering the question Are you satisfied to proceed with the laparoscopic cholecystectomy without a conventional intraoperative cholangiography?. The answers will be a binary Yes or No. |
Countries
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Contacts
Primary ContactZia Aftab, MBBS, FACS
Backup ContactShameel Musthafa, MBBS, FACS
Outcome results
None listed