Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis
NCT ID: NCT04624841
Last Updated: 2020-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2021-01-01
2022-01-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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ICG group
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.
Indocyanine Green
2.5-7.5 mg (0.05 mg/kg) injection
No ICG Group
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.
No interventions assigned to this group
Interventions
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Indocyanine Green
2.5-7.5 mg (0.05 mg/kg) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient age ≥ 18 years.
* Patients who consent to take part in the study
Exclusion Criteria
* Allergy towards iodine, iohexol or ICG
* Pregnancy or lactation
* Renal insufficiency
* Legally incompetent for any reason
* Withdrawal of inclusion consent at any time
* Prisoners
18 Years
ALL
No
Sponsors
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Hamad Medical Corporation
INDUSTRY
Responsible Party
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Dr Zia Ahmed Aftab, MBBS,FRCS,FACS
Consultant in Acute Care Surgery
Principal Investigators
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Zia Aftab, MBBS, FACS
Role: PRINCIPAL_INVESTIGATOR
Hamad Medical Corporation
Locations
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Hamad General Hospital
Doha, , Qatar
Countries
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Central Contacts
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Facility Contacts
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Zia Aftab
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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U1111-1256-1361
Identifier Type: OTHER
Identifier Source: secondary_id
IRGC-05-NI-18-362
Identifier Type: -
Identifier Source: org_study_id