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Acute CholecystitisPhase 4NCT04624841

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

A Phase 4 study testing Indocyanine Green in people with Acute Cholecystitis and Acute; Cholecystitis, Choledocholithiasis, run by Hamad Medical Corporation at 1 site in Qatar.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Indocyanine Green
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteQatar
Study dates
1 Jan 2021to 15 Jan 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Zia Aftab, MBBS, FACS contact

00974-66233904

zahmed5@hamad.qa

Shameel Musthafa, MBBS, FACS contact

00974-77274577

drshameelmusthafa@yahoo.com

Qatar1 site

  • Hamad General Hospital

    Doha, 3050

    Zia Aftab

Other trials in Qatar

About this study

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

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.

Read the 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.

Being tested
Indocyanine Green
Keywords
acute cholecystitis, laparoscopic cholecystectomy, critical view of safety, safe cholecystectomy, indocyanine green, operative cholangiogram, fluorescent imaging, near-infrared imaging
Medical subject headings
Cholecystitis, Acute, Cholecystitis, Choledocholithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine GreenDrug

    Also called ICG, fluorescent Imaging

    2.5-7.5 mg (0.05 mg/kg) injection

Study groups in NCT04624841
Study groupRoleWhat they receive
ICG groupExperimentalParticipants 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.
Receives: Drug: Indocyanine Green
No ICG GroupNo interventionNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.

Secondary outcomes (2)

  1. 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.

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

  2. 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.

    Measured: Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start1 Jan 2021 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion15 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04624841
Sponsor's protocol ID
IRGC-05-NI-18-362
Other IDs
U1111-1256-1361
Status last verified
Dec 2020
First submitted
30 Oct 2020
Last updated
16 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19380655

  • 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.

    PubMed 24616013

  • 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.

    PubMed 25277476

  • 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.

    PubMed 26167088

  • 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.

    PubMed 20706739

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Indocyanine Green in people with Acute Cholecystitis and Acute; Cholecystitis, Choledocholithiasis, run by Hamad Medical Corporation at 1 site in Qatar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zia Aftab, MBBS, FACS (00974-66233904, zahmed5@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of surgeries in which Critical View of Safety was achieved (time frame: Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04624841, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.

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