CholecystitisNCT05125653

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

A study testing Indocyanine Green Fluorescent Laparoscopic Cholangiography and White Light in people with Cholecystitis and Chronic Calculous Cholecystitis, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Cholecystitis, Chronic Calculous Cholecystitis, Acute Calculous Cholecystitis
What is being tested?: Indocyanine Green Fluorescent Laparoscopic Cholangiography and White Light
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2020to 1 Jul 2021
Phase: Interventional
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adults (from 18 to 75 years old)
suffering from a gall bladder disease
with valid indication for laparoscopic cholecystectomy (e.g., calculus gall bladder with cholecystitis)
accepted to participate in the study.

Who cannot join

Patients with history of previous biliary surgery
Patients with abdominal malignancy
Patients with advanced chronic liver disease
pregnant women

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Ain Shams University Hospitals - AUSH
Cairo

Other trials in Egypt

About this study

Official title: Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy, a Randomized Controlled Trial

This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy

Read the detailed description

A double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy in Ain-Shams University Specialized Hospital in the period from January 2020 till July 2021. Group A (n=60) underwent laparoscopic cholecystectomy using the usual white light, Group B (n=58) underwent laparoscopic cholecystectomy with ICG florescence cholangiography and intraoperative ICG florescence arteriography.

Conditions: Cholecystitis, Chronic Calculous Cholecystitis, Acute Calculous Cholecystitis
Being tested: Indocyanine Green Fluorescent Laparoscopic Cholangiography, White Light
Keywords: Laparoscopic Cholecystectomy, Indocyanine Green Fluorescent Cholangiography, Indocyanine Green Fluorescent Angiography
Medical subject headings: Cholecystitis, Cholecystitis, Acute

What participants receive

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

Indocyanine Green Fluorescent Laparoscopic CholangiographyProcedure or surgery
Also called Indocyanine Green Fluorescent LaparoscopicCholangiography
Indocyanine Green Fluorescent Cholangiography
White LightProcedure or surgery
Also called WL
Performing the laparoscopic cholecystectomy and identifying the biliary structures under the conventional white light

Study groups in NCT05125653
Study group	Role	What they receive
NIR/ICG Arm	Experimental	Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography will be done during the Laparoscopic Cholecystectomy Receives: Procedure: Indocyanine Green Fluorescent Laparoscopic Cholangiography
WL Arm	Active comparator	Conventional white light was used for Laparoscopic Cholecystectomy Receives: Procedure: White Light

What is being measured

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

Visual identification of the biliary tree
To measure the % of patients in which investigators can identify visually the extra hepatic biliary system (the CD, CBD, CHD, and any possible anomalies present), during LC.
Measured: during the procedure
Visual identification of the cystic artery
To measure the % of patients in which investigators can identify visually the cystic artery, during LC.
Measured: during the procedure

Secondary outcomes (5)

Visual identification of injuries
To detect of incidence rate of biliary or vascular injury, visually or clinically, resulted from miss identification of the structures.
Measured: during and imediatly after the procedure (24 hours)
Compare operative time
To compare the operative time in (minutes)
Measured: during the procedure
Compare blood loss
To compare the operative blood loss (in cc)
Measured: during the procedure
Compare blood loss in cc
To compare the blood loss (in cc) between the two groups.
Measured: during the procedure
Percentage of patients of ICG adverse reactions
To measure % of patients suffering off reactions related to the use of ICG (by vital data assessment, monitor patients' complaints, etc..)
Measured: Within 24 hour of the procedure

Timeline

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

1 Jan 20201 Jul 2021

First posted18 Nov 2021
Study start1 Jan 2020
Primary completion1 Jul 2021
Study completion1 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CholecystitisStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Model description: 2 arms, randomized, double blinded
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05125653
Sponsor's protocol ID: AinShamsSurg2
Status last verified: Nov 2021
First submitted: 4 Oct 2021
Last updated: 1 Dec 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
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SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
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Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
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Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
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All Cholecystitis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy, a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05125653
Acronym / sponsor ID: AinShamsSurg2
Conditions: Cholecystitis, Chronic Calculous Cholecystitis, Acute Calculous Cholecystitis
Keywords: Laparoscopic Cholecystectomy, Indocyanine Green Fluorescent Cholangiography, Indocyanine Green Fluorescent Angiography
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 1 Jul 2021 (actual)
Study completion: 1 Jul 2021 (actual)
First posted: 18 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: 2 arms, randomized, double blinded

Arm	Type	Receives
NIR/ICG Arm	Experimental	Procedure: Indocyanine Green Fluorescent Laparoscopic CholangiographyIndocyanine Green Fluorescent Cholangiography and Intraoperative Angiography will be done during the Laparoscopic Cholecystectomy
WL Arm	Active comparator	Procedure: White LightConventional white light was used for Laparoscopic Cholecystectomy

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

adults (from 18 to 75 years old)
suffering from a gall bladder disease
with valid indication for laparoscopic cholecystectomy (e.g., calculus gall bladder with cholecystitis)
accepted to participate in the study.

Key exclusion criteria (4 listed)

Patients with history of previous biliary surgery
Patients with abdominal malignancy
Patients with advanced chronic liver disease
pregnant women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Indocyanine Green Fluorescent Laparoscopic CholangiographyAlso: Indocyanine Green Fluorescent LaparoscopicCholangiographyIndocyanine Green Fluorescent Cholangiography	Procedure or surgery	NIR/ICG Arm
White LightAlso: WLPerforming the laparoscopic cholecystectomy and identifying the biliary structures under the conventional white light	Procedure or surgery	WL Arm

Primary outcome

Visual identification of the biliary tree
Time frame: during the procedure
To measure the % of patients in which investigators can identify visually the extra hepatic biliary system (the CD, CBD, CHD, and any possible anomalies present), during LC.
Visual identification of the cystic artery
Time frame: during the procedure
To measure the % of patients in which investigators can identify visually the cystic artery, during LC.

5 secondary outcomes

Visual identification of injuries
Time frame: during and imediatly after the procedure (24 hours)
Compare operative time
Time frame: during the procedure
Compare blood loss
Time frame: during the procedure
Compare blood loss in cc
Time frame: during the procedure
Percentage of patients of ICG adverse reactions
Time frame: Within 24 hour of the procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.

Related trials for Cholecystitis

Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Recruiting
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
Cholelithiasis, Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

M Abd-erRazik, MD study chair

Ain Shams University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Dec 2021. 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 Egypt. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual identification of the biliary tree (time frame: during the procedure). The study lists 2 primary outcomes in all. 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 NCT05125653.

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 1 Dec 2021.