Clinical trial NCT04624841: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Cholecystitis
Acute; Cholecystitis, Choledocholithiasis
Acute Cholecystitis With Obstruction
Keywords: acute cholecystitis
laparoscopic cholecystectomy
critical view of safety
safe cholecystectomy
indocyanine green
operative cholangiogram
fluorescent imaging
near-infrared imaging
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Percentage of surgeries in which Critical View of Safety was achieved
timeFrame: Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.
Secondary outcomes:
measure: Time taken to identify Critical View of Safety
timeFrame: After securing working ports till Clipping of Cystic Duct or Artery.
measure: Surgeon's Satisfaction Survey
timeFrame: Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad General Hospital
Study officials:
affiliation: Hamad Medical Corporation
name: Zia Aftab, MBBS, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ishizawa T, Bandai Y, Kokudo N. Fluorescent cholangiography using indocyanine green for laparoscopic cholecystectomy: an initial experience. Arch Surg. 2009 Apr;144(4):381-2. doi: 10.1001/archsurg.2009.9. No abstract available.
citation: Daskalaki D, Fernandes E, Wang X, Bianco FM, Elli EF, Ayloo S, Masrur M, Milone L, Giulianotti PC. Indocyanine green (ICG) fluorescent cholangiography during robotic cholecystectomy: results of 184 consecutive cases in a single institution. Surg Innov. 2014 Dec;21(6):615-21. doi: 10.1177/1553350614524839. Epub 2014 Mar 9.
citation: Dip F, Roy M, Lo Menzo E, Simpfendorfer C, Szomstein S, Rosenthal RJ. Routine use of fluorescent incisionless cholangiography as a new imaging modality during laparoscopic cholecystectomy. Surg Endosc. 2015 Jun;29(6):1621-6. doi: 10.1007/s00464-014-3853-7. Epub 2014 Oct 3.
citation: Pesce A, Piccolo G, La Greca G, Puleo S. Utility of fluorescent cholangiography during laparoscopic cholecystectomy: A systematic review. World J Gastroenterol. 2015 Jul 7;21(25):7877-83. doi: 10.3748/wjg.v21.i25.7877.
citation: Overby DW, Apelgren KN, Richardson W, Fanelli R; Society of American Gastrointestinal and Endoscopic Surgeons. SAGES guidelines for the clinical application of laparoscopic biliary tract surgery. Surg Endosc. 2010 Oct;24(10):2368-86. doi: 10.1007/s00464-010-1268-7. Epub 2010 Aug 13. No abstract available.