Extrahepatic Biliary Tree InjuryPhase 2/3HQFCNCT05926856
High Quality Fluorescent Cholangiography
A Phase 2/3 study testing Indocyanine green in people with Extrahepatic Biliary Tree Injury, run by Zhujiang Hospital at 1 site in China.
Trial summary
The goal of this randomized controlled trial is to compare the quality of extrahepatic biliary fluorescent visualization under two injection protocols to optimize extrahepatic biliary cholangiography. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extrahepatic Biliary Tree Injury
- 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
- 168 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2023to 11 Dec 2023
- Phase
- Phase 2/3
- 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
- The patient has indications for cholecystectomy and requires laparoscopic treatment；
- No biliary obstruction or cholestasis was found during preoperative examination；3.Volunteer to participate in this clinical trial and sign written informed consent.
Who cannot join
- Patients who require emergency surgical treatment；
- Patients with malignant tumors of the biliary tract；
- Patients with a history of abdominal surgery；
- Patients who are allergic to indocyanine green or iodine contrast agents；5.Patients participating in one or more other clinical trials simultaneously；
- 6.Patients who have received medication that affects bile excretion within 2 weeks before surgery； 7.Other situations that have been judged unsuitable for inclusion by researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Fluorescent Visualization of the Extrahepatic Biliary Tract Between Two Injection Protocols
The goal of this randomized controlled trial is to compare the quality of extrahepatic biliary fluorescent visualization under two injection protocols to optimize extrahepatic biliary cholangiography.
Read the detailed description
Biliary fluorescence imaging is widely used to identify the extrahepatic biliary tract during laparoscopic cholecystectomy. However, fluorescent developer Indocyanine Green（ICG） still lacks standardization, and not every visualization of the extrahepatic biliary tract is satisfactory. Some research groups have shown that injection of ICG 1 day before surgery can achieve the best fluorescence imaging of the biliary tract, but some research groups have suggested that injection of a very low dose of ICG 45 minutes before surgery can improve the satisfaction of fluorescence imaging. However, no study compares the quality of biliary fluorescence imaging between the two injection protocols. This study will compare the fluorescence imaging effects of the two schemes to obtain the best injection scheme at present and standardize the use of icg.
- Conditions
- Extrahepatic Biliary Tree Injury
- Being tested
- Indocyanine green
- Keywords
- icg, fluorescent cholangiograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Indocyanine Green 25mg kit for injection
| Study group | Role | What they receive |
|---|---|---|
| 1 day before surgery | Active comparator | 0.25mg/kg Indocyanine Green will be administered 1 day before surgery Receives: Drug: Indocyanine green |
| 45 min before surgery | Experimental | 0.05mg Indocyanine Green will be administered 45minutes before surgery Receives: Drug: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common bile duct-to-liver fluorescence intensity ratio
Common bile duct-to-liver fluorescence intensity ratio
Measured: Intraoperative (The beginning of the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start4 Aug 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic Biliary Tree InjuryStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chihua Fang,MD, Zhujiang Hospital
- Investigators
- Jian Yang, MD, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926856
- Sponsor's protocol ID
- 20230420
- Acronym
- HQFC
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Fluorescent Visualization of the Extrahepatic Biliary Tract Between Two Injection Protocols
- ClinicalTrials.gov ID
- NCT05926856
- Acronym / sponsor ID
- HQFC / 20230420
- Conditions
- Extrahepatic Biliary Tree Injury
- Keywords
- icg, fluorescent cholangiograph
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 3 Jul 2023 (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.
The goal of this randomized controlled trial is to compare the quality of extrahepatic biliary fluorescent visualization under two injection protocols to optimize extrahepatic biliary cholangiography.
Detailed description
Biliary fluorescence imaging is widely used to identify the extrahepatic biliary tract during laparoscopic cholecystectomy. However, fluorescent developer Indocyanine Green（ICG） still lacks standardization, and not every visualization of the extrahepatic biliary tract is satisfactory. Some research groups have shown that injection of ICG 1 day before surgery can achieve the best fluorescence imaging of the biliary tract, but some research groups have suggested that injection of a very low dose of ICG 45 minutes before surgery can improve the satisfaction of fluorescence imaging. However, no study compares the quality of biliary fluorescence imaging between the two injection protocols. This study will compare the fluorescence imaging effects of the two schemes to obtain the best injection scheme at present and standardize the use of icg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 day before surgery | Active comparator | Drug: Indocyanine green0.25mg/kg Indocyanine Green will be administered 1 day before surgery |
| 45 min before surgery | Experimental | Drug: Indocyanine green0.05mg Indocyanine Green will be administered 45minutes before surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient has indications for cholecystectomy and requires laparoscopic treatment；
- No biliary obstruction or cholestasis was found during preoperative examination；3.Volunteer to participate in this clinical trial and sign written informed consent.
Key exclusion criteria (5 listed)
- Patients who require emergency surgical treatment；
- Patients with malignant tumors of the biliary tract；
- Patients with a history of abdominal surgery；
- Patients who are allergic to indocyanine green or iodine contrast agents；5.Patients participating in one or more other clinical trials simultaneously；
- 6.Patients who have received medication that affects bile excretion within 2 weeks before surgery； 7.Other situations that have been judged unsuitable for inclusion by researchers.
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 greenIndocyanine Green 25mg kit for injection | Drug | 1 day before surgery, 45 min before surgery |
Primary outcome
Common bile duct-to-liver fluorescence intensity ratio
Time frame: Intraoperative (The beginning of the surgery)
Common bile duct-to-liver fluorescence intensity ratio
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 18 Dec 2023.
- Individual participant dataSharing planned: No
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.
Jian Yang, MD principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Indocyanine green in people with Extrahepatic Biliary Tree Injury, run by Zhujiang Hospital at 1 site in China.
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 2 inclusion and 5 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 18 Dec 2023. 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 China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Common bile duct-to-liver fluorescence intensity ratio (time frame: Intraoperative (The beginning of the surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2023.