Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis

Acute Cholecystitis Clinical Trial

Official title:

Role of Indocyanine Green in Visualizing Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04624841
• Other study ID #: IRGC-05-NI-18-362
• Secondary ID: U1111-1256-1361
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: December 2020
• Source: Hamad Medical Corporation
• Contact: Zia Aftab, MBBS, FACS
• Phone: 00974-66233904
• Email: zahmed5[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 15, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Acute Cholecystitis With Obstruction
• Acute; Cholecystitis, Choledocholithiasis
• Cholecystitis
• Cholecystitis, Acute
• Choledocholithiasis

Intervention

Drug:
• Indocyanine Green
2.5-7.5 mg (0.05 mg/kg) injection

Locations

Country	Name	City	State
Qatar	Hamad General Hospital	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of surgeries in which Critical View of Safety was achieved	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.	Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.
Secondary	Time taken to identify Critical View of Safety	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.	After securing working ports till Clipping of Cystic Duct or Artery.
Secondary	Surgeon's Satisfaction Survey	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.	Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.