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

NCT04624841 | Unknown Phase 4 DMC

• 2 other identifiers: IRGC-05-NI-18-362U1111-1256-1361
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time taken to identify Critical View of Safety

  After securing working ports till Clipping of Cystic Duct or Artery.

• 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.

Study Arms (2)

ICG group

EXPERIMENTAL

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.

Drug: Indocyanine Green

No ICG Group

NO INTERVENTION

No ICG is administered after randomization of the patient to a control group and hence will not produce any enhancement of the image on A Pinpoint Endoscopic Fluorescence System for ICG Fluorescence Observation. This will continue as a routine Laparoscopic cholecystectomy without fluorescent imaging enhancement.

Interventions

Indocyanine Green DRUG

2.5-7.5 mg (0.05 mg/kg) injection

Also known as: ICG, fluorescent Imaging

ICG group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled for emergency Laparoscopic Cholecystectomy for Acute Cholecystitis
• Patient age ≥ 18 years.
• Patients who consent to take part in the study

You may not qualify if:

• Preoperative planned for Open Cholecystectomy
• Allergy towards iodine, iohexol or ICG
• Pregnancy or lactation
• Renal insufficiency
• Legally incompetent for any reason
• Prisoners

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad General Hospital

Doha, 3050, Qatar

Location

Related Publications (5)

• 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.

  PMID: 19380655 BACKGROUND

• 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.

  PMID: 24616013 BACKGROUND

• 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.

  PMID: 25277476 BACKGROUND

• 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.

  PMID: 26167088 BACKGROUND

• 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.

  PMID: 20706739 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute; Cholecystitis; Choledocholithiasis

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Bile Duct Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zia Aftab, MBBS, FACS

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zia Aftab, MBBS, FACS

CONTACT

00974-66233904; zahmed5@hamad.qa

Shameel Musthafa, MBBS, FACS

CONTACT

00974-77274577; drshameelmusthafa@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Acute Care Surgery

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 12, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 15, 2022
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)