CholelithiasisNCT04228835
Does ICG Fluorescence Cholangiography Identify Critical View of Safety Earlier in Laparoscopic Cholecystectomy
A study testing Fluorescence Cholangiography in people with Cholelithiasis, run by University of Malaya at 1 site in Malaysia.
Trial summary
Achievement of critical view of safety (CVS) is recommended to reduce risk of hilar injury in laparoscopic cholecystectomy. Indocyanine green (ICG) fluorescence cholangiography, a novel technique of real time biliary visualization, is postulated to assist dissection during laparoscopic cholecystectomy (LC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Fluorescence Cholangiography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2017to 31 Jul 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptomatic cholelithiasis for elective cholecystectomy
- American Society of Anaesthesiologist (ASA) classification of physical status I or II
- Normal kidney function
- Normal liver function
Who cannot join
- Liver cirrhosis
- Hepatits B or C
- Allergies to iodine or seafood
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: Does ICG Fluorescence Cholangiography Identify Critical View of Safety Earlier in Laparoscopic Cholecystectomy: Results From a Randomized Controlled Study in University Malaya Medical Centre
Achievement of critical view of safety (CVS) is recommended to reduce risk of hilar injury in laparoscopic cholecystectomy. Indocyanine green (ICG) fluorescence cholangiography, a novel technique of real time biliary visualization, is postulated to assist dissection during laparoscopic cholecystectomy (LC). However, its use in providing a faster and safer LC has yet to be established. The main objective of this study is to evaluate whether the use of ICG enhanced fluorescence cholangiography will help in earlier identification critical view of safety during LC.
Read the detailed description
Indocyanine green (ICG) is excreted exclusively in the biliary system and emits fluorescence light when viewed using near infrared imaging. This enables extrahepatic biliary tree anatomy to be delineated during laparoscopic cholecystectomy.
Indocyanine green fluorescence cholangiography also enables earlier detection of cystic duct and common bile duct during laparoscopic cholecystectomy. This is reported in two studies which showed that cystic duct can be identified 11 minutes and 8.6 minutes earlier and common bile duct 10 and 11 minutes earlier than white light imaging.
To date, there is no data published on the use of fluorescent cholangiography in reducing operative time of identification of critical view of safety during laparoscopic cholecystectomy, which is an integral part of the surgery. Theoretically achievement of critical view of safety maybe facilitated by fluorescent cholangiography as this technique facilitates identification of biliary structures.
The primary objective of this study is to evaluate whether an earlier identification of CVS can be obtained by using ICG fluorescence cholangiography as an adjunct to conventional laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy. Secondary outcomes assessed are the presence of minor or major complications between this two groups.
Patients are randomly assigned into two arms; ICG fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC- LC) and conventional laparoscopic cholecystectomy (LC), using a computer-generated block randomization. Patients in the ICGFC- LC group received intravenous bolus of 2.5mg of ICG before the induction of anaesthesia. All the surgeries are performed using standard four ports technique. Near infrared light camera by Karl Storz Endoscopy is used intermittently during dissection for the ICGFC-LC group.
Time to identification of CVS is defined by time of gallbladder retraction to time of establishment of critical view of safety. Critical view of safety is achieved when all the three criteria set by Strasberg is met. Mean time to identification of CVS in the two groups of patients were then compared. All patients are followed up for one month to identify any post-operative complications.
- Conditions
- Cholelithiasis
- Being tested
- Fluorescence Cholangiography
- Keywords
- Symptomatic and Complicated Cholelithiasis
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence CholangiographyDiagnostic test
Administration of ICG for fluorescence cholangiography
| Study group | Role | What they receive |
|---|---|---|
| ICGFC-LC | Experimental | ICG fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC-LC) arm patients received intravenous bolus of 2.5mg of ICG before the induction of anaesthesia. Near infrared laparoscopic light camera was utilized intermittently during dissection of Calot's triangle until critical view of safety was achieved. Receives: Diagnostic Test: Fluorescence Cholangiography |
| Conventional LC | No intervention | Conventional laparoscopic cholecystectomy (LC) arm patients underwent standard white light laparoscopic cholecystectomy without fluorescence cholangiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to identification of critical view of safety
Compare time to identification of critical view of safety during laparoscopic cholecystectomy which is defined as time of gallbladder retraction until establishment of critical view of safety.
Measured: Time of surgery
Secondary outcomes (1)
Complications
Compare rate of complications of laparoscopic cholecystectomy such as bile duct injury, major haemorrhage, intraabdominal collections and surgical site infection
Measured: up to 30 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Mar 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are divided into two arms: ICG enhanced fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC- LC) and conventional laparoscopic cholecystectomy.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Ummi Surgical Sdn Bhd
- Responsible party
- Principal investigator, Dr Koong Jun Kit, University of Malaya
- Investigators
- Jun Kit Koong, MS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228835
- Sponsor's protocol ID
- 1001
- Status last verified
- Jan 2020
- First submitted
- 27 Nov 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schols RM, Bouvy ND, van Dam RM, Masclee AA, Dejong CH, Stassen LP. Combined vascular and biliary fluorescence imaging in laparoscopic cholecystectomy. Surg Endosc. 2013 Dec;27(12):4511-7. doi: 10.1007/s00464-013-3100-7. Epub 2013 Jul 23.
PubMed 23877766van Dam DA, Ankersmit M, van de Ven P, van Rijswijk AS, Tuynman JB, Meijerink WJ. Comparing Near-Infrared Imaging with Indocyanine Green to Conventional Imaging During Laparoscopic Cholecystectomy: A Prospective Crossover Study. J Laparoendosc Adv Surg Tech A. 2015 Jun;25(6):486-92. doi: 10.1089/lap.2014.0248. Epub 2015 May 14.
PubMed 25974072Koong JK, Ng GH, Ramayah K, Koh PS, Yoong BK. Early identification of the critical view of safety in laparoscopic cholecystectomy using indocyanine green fluorescence cholangiography: A randomised controlled study. Asian J Surg. 2021 Mar;44(3):537-543. doi: 10.1016/j.asjsur.2020.11.002. Epub 2020 Nov 19.
PubMed 33223453
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does ICG Fluorescence Cholangiography Identify Critical View of Safety Earlier in Laparoscopic Cholecystectomy: Results From a Randomized Controlled Study in University Malaya Medical Centre
- ClinicalTrials.gov ID
- NCT04228835
- Acronym / sponsor ID
- 1001
- Conditions
- Cholelithiasis
- Keywords
- Symptomatic and Complicated Cholelithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Ummi Surgical Sdn Bhd
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 14 Jan 2020 (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.
Achievement of critical view of safety (CVS) is recommended to reduce risk of hilar injury in laparoscopic cholecystectomy. Indocyanine green (ICG) fluorescence cholangiography, a novel technique of real time biliary visualization, is postulated to assist dissection during laparoscopic cholecystectomy (LC). However, its use in providing a faster and safer LC has yet to be established. The main objective of this study is to evaluate whether the use of ICG enhanced fluorescence cholangiography will help in earlier identification critical view of safety during LC.
Detailed description
Indocyanine green (ICG) is excreted exclusively in the biliary system and emits fluorescence light when viewed using near infrared imaging. This enables extrahepatic biliary tree anatomy to be delineated during laparoscopic cholecystectomy.
Indocyanine green fluorescence cholangiography also enables earlier detection of cystic duct and common bile duct during laparoscopic cholecystectomy. This is reported in two studies which showed that cystic duct can be identified 11 minutes and 8.6 minutes earlier and common bile duct 10 and 11 minutes earlier than white light imaging.
To date, there is no data published on the use of fluorescent cholangiography in reducing operative time of identification of critical view of safety during laparoscopic cholecystectomy, which is an integral part of the surgery. Theoretically achievement of critical view of safety maybe facilitated by fluorescent cholangiography as this technique facilitates identification of biliary structures.
The primary objective of this study is to evaluate whether an earlier identification of CVS can be obtained by using ICG fluorescence cholangiography as an adjunct to conventional laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy. Secondary outcomes assessed are the presence of minor or major complications between this two groups.
Patients are randomly assigned into two arms; ICG fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC- LC) and conventional laparoscopic cholecystectomy (LC), using a computer-generated block randomization. Patients in the ICGFC- LC group received intravenous bolus of 2.5mg of ICG before the induction of anaesthesia. All the surgeries are performed using standard four ports technique. Near infrared light camera by Karl Storz Endoscopy is used intermittently during dissection for the ICGFC-LC group.
Time to identification of CVS is defined by time of gallbladder retraction to time of establishment of critical view of safety. Critical view of safety is achieved when all the three criteria set by Strasberg is met. Mean time to identification of CVS in the two groups of patients were then compared. All patients are followed up for one month to identify any post-operative complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are divided into two arms: ICG enhanced fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC- LC) and conventional laparoscopic cholecystectomy.
| Arm | Type | Receives |
|---|---|---|
| ICGFC-LC | Experimental | Diagnostic Test: Fluorescence CholangiographyICG fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC-LC) arm patients received intravenous bolus of 2.5mg of ICG before the induction of anaesthesia. Near infrared laparoscopic light camera was utilized intermittently during dissection of Calot's triangle until critical view of safety was achieved. |
| Conventional LC | No intervention | –Conventional laparoscopic cholecystectomy (LC) arm patients underwent standard white light laparoscopic cholecystectomy without fluorescence cholangiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic cholelithiasis for elective cholecystectomy
- American Society of Anaesthesiologist (ASA) classification of physical status I or II
- Normal kidney function
- Normal liver function
Key exclusion criteria (3 listed)
- Liver cirrhosis
- Hepatits B or C
- Allergies to iodine or seafood
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 |
|---|---|---|
| Fluorescence CholangiographyAdministration of ICG for fluorescence cholangiography | Diagnostic test | ICGFC-LC |
Primary outcome
Time to identification of critical view of safety
Time frame: Time of surgery
Compare time to identification of critical view of safety during laparoscopic cholecystectomy which is defined as time of gallbladder retraction until establishment of critical view of safety.
1 secondary outcome
Complications
Time frame: up to 30 days post operative
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 14 Jan 2020.
- Background: PubMed 23877766Schols RM, Bouvy ND, van Dam RM, Masclee AA, Dejong CH, Stassen LP. Combined vascular and biliary fluorescence imaging in laparoscopic cholecystectomy. Surg Endosc. 2013 Dec;27(12):4511-7. doi: 10.1007/s00464-013-3100-7. Epub 2013 Jul 23.
- Background: PubMed 25974072van Dam DA, Ankersmit M, van de Ven P, van Rijswijk AS, Tuynman JB, Meijerink WJ. Comparing Near-Infrared Imaging with Indocyanine Green to Conventional Imaging During Laparoscopic Cholecystectomy: A Prospective Crossover Study. J Laparoendosc Adv Surg Tech A. 2015 Jun;25(6):486-92. doi: 10.1089/lap.2014.0248. Epub 2015 May 14.
- Derived from this study: PubMed 33223453Koong JK, Ng GH, Ramayah K, Koh PS, Yoong BK. Early identification of the critical view of safety in laparoscopic cholecystectomy using indocyanine green fluorescence cholangiography: A randomised controlled study. Asian J Surg. 2021 Mar;44(3):537-543. doi: 10.1016/j.asjsur.2020.11.002. Epub 2020 Nov 19.
- Individual participant dataSharing planned: No
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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.
Jun Kit Koong, MS principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescence Cholangiography in people with Cholelithiasis, run by University of Malaya at 1 site in Malaysia.
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 3 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 14 Jan 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 Malaysia. 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?
Time to identification of critical view of safety (time frame: Time of surgery). 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 NCT04228835, which also lists 3 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 14 Jan 2020.