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

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Qatar
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Cholecystitis focused on measuring acute cholecystitis, laparoscopic cholecystectomy, critical view of safety, safe cholecystectomy, indocyanine green, operative cholangiogram, fluorescent imaging, near-infrared imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamad General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ICG group

No ICG Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 30, 2020
Last Updated
December 13, 2020
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04624841
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
January 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICG group
Arm Type
Experimental
Arm Description
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.
Arm Title
No ICG Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
ICG, fluorescent Imaging
Intervention Description
2.5-7.5 mg (0.05 mg/kg) injection
Primary Outcome Measure Information:
Title
Percentage of surgeries in which Critical View of Safety was achieved
Description
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.
Time Frame
Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.
Secondary Outcome Measure Information:
Title
Time taken to identify Critical View of Safety
Description
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.
Time Frame
After securing working ports till Clipping of Cystic Duct or Artery.
Title
Surgeon's Satisfaction Survey
Description
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.
Time Frame
Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zia Aftab, MBBS, FACS
Phone
00974-66233904
Email
zahmed5@hamad.qa
First Name & Middle Initial & Last Name or Official Title & Degree
Shameel Musthafa, MBBS, FACS
Phone
00974-77274577
Email
drshameelmusthafa@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zia Aftab, MBBS, FACS
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad General Hospital
City
Doha
ZIP/Postal Code
3050
Country
Qatar
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zia Aftab

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19380655
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.
Results Reference
background
PubMed Identifier
24616013
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.
Results Reference
background
PubMed Identifier
25277476
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.
Results Reference
background
PubMed Identifier
26167088
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.
Results Reference
background
PubMed Identifier
20706739
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.
Results Reference
background

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

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