Stomach NeoplasmNCT05971069
Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging
A study testing Group1, Group2 and Group3 in people with Stomach Neoplasm, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
" Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation should consider the oncologic safety and liver-related complication. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- Group1, Group2 and Group3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2021to 12 Jun 2023
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with gastric adenocarcinoma pathologically before surgery
- Patients aged between 20 to 80
- Patients with an ECOG 0 or 1
- Patients who were confirmed the presence of aberrant left hepatic artery before or during surgery
Who cannot join
- Patients with abnormal liver function test befor surgery
- Patients who diagnosed liver cirrhosis or infectious liver disease
- Patients who underwent liver resection, or chemotherapy for gastric cancer
- Patients planned for combined liver resection or cholecystectomy during gastrectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging: Prospective Study to Develop Decision Algorithm to Define the Preservation/Ligation of an Aberrant Left Hepatic Artery
" Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation should consider the oncologic safety and liver-related complication. Theoretically, the ALHA preservation is the most ideal in the aspect of liver function protection. However, it is technically difficult which consumes much time. Not only that, oncologic safety could be threatened as some soft tissues, including lymph nodes, could be remained while in preserving the ALHA.
There has been no standardized method to evaluate the ALHA, and to decide whether preserve or ligate it.
This prospective study has been designed to develop the decision algorithm to define the ALHA preservation/ligation, using near-infrared fluorescence imaging during surgery. "
- Conditions
- Stomach Neoplasm
- Being tested
- Group1, Group2, Group3
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group1Procedure or surgery
Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery
Group2Procedure or surgery
Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
Group3Procedure or surgery
No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery Receives: Procedure: Group1 |
| Group2 | Experimental | Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery Receives: Procedure: Group2 |
| Group3 | Experimental | No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery Receives: Procedure: Group3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging
Investigator discretionally designed the decision algorithm for aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging.
The order of the algorithm is as follows:
First, when surgeons identify the aberrant left hepatic artery during surgery, clamping the artery and injectioning indocyanine green (5mg/mL) intravenously would be performed.
After that, in a few seconds, liver perfusion could be detected through real time near-infrared fluorescence imaging.
The ligation or preservation of the aberrant left hepatic artery would be decided according to the proportion of the near-infrared fluorescence imaging defect. Investigator's like to confirm the safety and efficacity of this decision algorithm.
Measured: Real time near-infrared fluorescence image will be obtained during the surgery.
Secondary outcomes (1)
Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)
The elevated proprtion of the serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) compared to preoperative value will be calculated and compared by groups.
Measured: Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start17 Dec 2021
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Gyu Kwon, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971069
- Sponsor's protocol ID
- 3-2021-0376
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Identification of the Aberrant Left Hepatic Arterial Territory in the Liver Using Near-infrared Fluorescence Imaging: Prospective Study to Develop Decision Algorithm to Define the Preservation/Ligation of an Aberrant Left Hepatic Artery
- ClinicalTrials.gov ID
- NCT05971069
- Acronym / sponsor ID
- 3-2021-0376
- Conditions
- Stomach Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 2 Aug 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.
" Hepatic artery variants are occasionally seen, especially 20-30% of aberrant left hepatic artery. In radical gastrectomy, decision for aberrant left hepatic artery(ALHA) ligation should consider the oncologic safety and liver-related complication. Theoretically, the ALHA preservation is the most ideal in the aspect of liver function protection. However, it is technically difficult which consumes much time. Not only that, oncologic safety could be threatened as some soft tissues, including lymph nodes, could be remained while in preserving the ALHA.
There has been no standardized method to evaluate the ALHA, and to decide whether preserve or ligate it.
This prospective study has been designed to develop the decision algorithm to define the ALHA preservation/ligation, using near-infrared fluorescence imaging during surgery. "
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Procedure: Group1Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery |
| Group2 | Experimental | Procedure: Group2Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery |
| Group3 | Experimental | Procedure: Group3No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with gastric adenocarcinoma pathologically before surgery
- Patients aged between 20 to 80
- Patients with an ECOG 0 or 1
- Patients who were confirmed the presence of aberrant left hepatic artery before or during surgery
Key exclusion criteria (4 listed)
- Patients with abnormal liver function test befor surgery
- Patients who diagnosed liver cirrhosis or infectious liver disease
- Patients who underwent liver resection, or chemotherapy for gastric cancer
- Patients planned for combined liver resection or cholecystectomy during gastrectomy
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 |
|---|---|---|
| Group1Entire fluorescence defect on the Lt. lobe of liver → Preservation of the aberrant left hepatic artery | Procedure or surgery | Group1 |
| Group2Partial fluorecence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery | Procedure or surgery | Group2 |
| Group3No fluorescence defect on the Lt. lobe of liver → Ligation of the aberrant left hepatic artery | Procedure or surgery | Group3 |
Primary outcome
The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging
Time frame: Real time near-infrared fluorescence image will be obtained during the surgery.
Investigator discretionally designed the decision algorithm for aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging. The order of the algorithm is as follows: First, when surgeons identify the aberrant left hepatic artery during surgery, clamping the artery and injectioning indocyanine green (5mg/mL) intravenously would be performed. After that, in a few seconds, liver perfusion could be detected through real time near-infrared fluorescence imaging. The ligation or preservation of the aberrant left hepatic artery would be decided according to the proportion of the near-infrared fluorescence imaging defect. Investigator's like to confirm the safety and efficacity of this decision algorithm.
1 secondary outcome
Number of participants with liver-related postoperative complications as assessed by serum aspartate transaminase(AST) and alanine transferase(ALT)
Time frame: Serum aspartate transaminase(AST, IU/L) and alanine transferase(ALT, IU/L) will be estimated in postoperative 1st, 2nd, 3rd and 5th day.
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 2 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group1, Group2 and Group3 in people with Stomach Neoplasm, run by Gangnam Severance Hospital at 1 site in South Korea.
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 2 Aug 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 South Korea. 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?
The safety and efficacy of the decision algorithm for the aberrant left hepatic artery preservation/ligation with real time near-infrared fluorescence imaging (time frame: Real time near-infrared fluorescence image will be obtained during 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 2 Aug 2023.