Gastric CancerPhase 33D-4K-ICGNCT06161207
3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer
A Phase 3 study testing Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection in people with Gastric Cancer and Surgery, run by Fujian Medical University at 1 site in China.
Trial summary
Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Surgery
- What is being tested?
- Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 702 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2023to 1 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age from 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
- No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations
- Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Who cannot join
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR for gastric cancer)
- Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging
- Other malignant disease within the past 5 years
Show all 16Show fewer
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement for simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1 (forced expiratory volume in one second)<50% of predicted values
- Diffuse invasive gastric cancer
- History of an iodine allergy
- Patients who declined laparoscopic surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Changming Huang, MD, +86-133-6591-0253, hcmlr2002@163.com
Changming Huang, MD
About this study
Official title: Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in 3D Plus Ultra High Resolution Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer
Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.
Read the detailed description
- Research purpose: Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.
- Research design: Prospective, single-center, randomized controlled, open-control, parallel assignment, superiority test.
2.1 Case group Group A (Study Group 1, 234 cases): ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection; Group B (Study Group 2, 234 cases): ICG near-infrared imaging tracing in ultra high resolution laparoscopic gastrectomy with lymph node dissection; Group C (Control Group 2, 234 cases) 3D laparoscopic gastrectomy with lymph node dissection
2.2 Estimate Sample Size The three-year disease-free survival (DFS) was the main effectiveness evaluation index in this study. The study implemented a superiority test (unilateral), assuming that both the study group's three-year DFS would be better than that of control group, according to previous research results of laparoscopic surgery for locally advanced GC in which the three-year DFS was 65.2%; therefore, the 3-year DFS of the control group would be 65.2%, assuming that the 3-year DFS of the experimental group could be increased by 12% to 77.2%. With an inspection level 0.0125 (unilateral) and an inspection efficiency of 0.8 and using PASS 11 log-rank tests (Lakatos) [Proportion surviving] the calculated sample size was N=211; namely, each group needed 211 people, considering cases of possible exclusion and loss to follow-up (10% drop out rate). The final sample size for each group was 234 cases, for a total of 702 cases.
2.3 randomization After laparoscopic exploration and confirmation that the cases complied with the standards, they were included in the randomized groups in this study. SAS 9.2 was used to produce a serial number ranging from 0001 - 702 corresponding to the treatment allocation, which was reserved in the data center and research center.
2.4 Blinding Method: This research adopts an open design.
2.5 Research cycle: Estimated enrollment cycle: complete enrollment within 2 years. Follow-up period: the enrollment of the first case was the starting point for follow-up. And the enrollment of last case to the postoperative pathology report (generally 2 weeks after surgery) was the endpoint of follow-up for secondary outcomes. Three years after the last case was enrolled was the follow-up endpoint for the main outcomes.
Estimated time: 2023.12-2025.12 (complete enrollment) to 2028.12 (complete follow-up)
Study Objects All patients who meet the inclusion criteria and do not conform to the exclusion criteria are qualified for this study.
- Conditions
- Gastric Cancer, Surgery
- Being tested
- Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection
- Keywords
- Indocyanine Green Tracer, Laparoscopic Gastrectomy, Gastric Cancer, Ultra High Resolution, 3D
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node DissectionProcedure or surgery
Indocyanine green tracer is used with 3D plus ultra high resolution laparoscopic gastrectomy with lymph node Dissection for gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| 3D-4K-ICG | Experimental | Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection Receives: Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection |
| 4K-ICG | Experimental | Indocyanine Green Tracer Using in Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection Receives: Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection |
| 3D | Placebo comparator | 3D Laparoscopic Gastrectomy with Lymph Node Dissection Receives: Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
Disease-free survival is calculated from the day of surgery to the day of recurrence or death
Measured: 3 years
Secondary outcomes (23)
Operation time
Operation time
Measured: 1 day
Total number of retrieved lymph nodes
Total number of retrieved lymph nodes
Measured: 1 day
Noncompliance rate of lymph node dissection
Noncompliance rate of lymph node dissection
Measured: 1 day
Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A
Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A
Measured: 1 day
Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)
Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)
Measured: 1 day
Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)
Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)
Measured: 1 day
Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)
Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)
Measured: 1 day
Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)
Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)
Measured: 1 day
Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B
Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B
Measured: 1 day
Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)
Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)
Measured: 1 day
Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)
Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)
Measured: 1 day
Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)
Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)
Measured: 1 day
Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)
Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)
Measured: 1 day
Number of metastatic lymph nodes
Number of metastatic lymph nodes
Measured: 1 day
Metastasis rate of lymph nodes
Metastasis rate of lymph nodes
Measured: 1 day
Morbidity and mortality rates
Morbidity and mortality rates
Measured: 30 day
3-year overall survival rate
3-year overall survival rate
Measured: 3 years
3-year recurrence pattern
3-year recurrence pattern
Measured: 3 years
Postoperative recovery course
Postoperative recovery course
Measured: 30 days
Intraoperative situation
Intraoperative situation
Measured: 30 days
Postoperative nutritional status
Postoperative nutritional status
Measured: 3 years
Inflammatory and immune response
Inflammatory and immune response
Measured: 30 days
Postoperative quality of life (measured by EQ-5D)
Postoperative quality of life (measured by EQ-5D)
Measured: preoperative, postoperative 1 month and postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start3 Jan 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 702 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University Union Hospital
- Investigators
- Chang-ming Huang, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161207
- Sponsor's protocol ID
- FUGES-31
- Acronym
- 3D-4K-ICG
- Status last verified
- Jun 2024
- First submitted
- 30 Nov 2023
- Last updated
- 24 Jun 2024
- 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in 3D Plus Ultra High Resolution Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06161207
- Acronym / sponsor ID
- 3D-4K-ICG / FUGES-31
- Conditions
- Gastric Cancer, Surgery
- Keywords
- Indocyanine Green Tracer, Laparoscopic Gastrectomy, Gastric Cancer, Ultra High Resolution, 3D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 702 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 7 Dec 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.
Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.
Detailed description
- Research purpose: Patients with locally advanced gastric adenocarcinoma (CT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.
- Research design: Prospective, single-center, randomized controlled, open-control, parallel assignment, superiority test.
2.1 Case group Group A (Study Group 1, 234 cases): ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection; Group B (Study Group 2, 234 cases): ICG near-infrared imaging tracing in ultra high resolution laparoscopic gastrectomy with lymph node dissection; Group C (Control Group 2, 234 cases) 3D laparoscopic gastrectomy with lymph node dissection
2.2 Estimate Sample Size The three-year disease-free survival (DFS) was the main effectiveness evaluation index in this study. The study implemented a superiority test (unilateral), assuming that both the study group's three-year DFS would be better than that of control group, according to previous research results of laparoscopic surgery for locally advanced GC in which the three-year DFS was 65.2%; therefore, the 3-year DFS of the control group would be 65.2%, assuming that the 3-year DFS of the experimental group could be increased by 12% to 77.2%. With an inspection level 0.0125 (unilateral) and an inspection efficiency of 0.8 and using PASS 11 log-rank tests (Lakatos) [Proportion surviving] the calculated sample size was N=211; namely, each group needed 211 people, considering cases of possible exclusion and loss to follow-up (10% drop out rate). The final sample size for each group was 234 cases, for a total of 702 cases.
2.3 randomization After laparoscopic exploration and confirmation that the cases complied with the standards, they were included in the randomized groups in this study. SAS 9.2 was used to produce a serial number ranging from 0001 - 702 corresponding to the treatment allocation, which was reserved in the data center and research center.
2.4 Blinding Method: This research adopts an open design.
2.5 Research cycle: Estimated enrollment cycle: complete enrollment within 2 years. Follow-up period: the enrollment of the first case was the starting point for follow-up. And the enrollment of last case to the postoperative pathology report (generally 2 weeks after surgery) was the endpoint of follow-up for secondary outcomes. Three years after the last case was enrolled was the follow-up endpoint for the main outcomes.
Estimated time: 2023.12-2025.12 (complete enrollment) to 2028.12 (complete follow-up)
Study Objects All patients who meet the inclusion criteria and do not conform to the exclusion criteria are qualified for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3D-4K-ICG | Experimental | Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node DissectionIndocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection |
| 4K-ICG | Experimental | Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node DissectionIndocyanine Green Tracer Using in Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection |
| 3D | Placebo comparator | Procedure: Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection3D Laparoscopic Gastrectomy with Lymph Node Dissection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
- No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations
- Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
Key exclusion criteria (16 listed)
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR for gastric cancer)
- Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging
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 Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node DissectionIndocyanine green tracer is used with 3D plus ultra high resolution laparoscopic gastrectomy with lymph node Dissection for gastric cancer | Procedure or surgery | 3D, 3D-4K-ICG, 4K-ICG |
Primary outcome
3-year disease free survival rate
Time frame: 3 years
Disease-free survival is calculated from the day of surgery to the day of recurrence or death
23 secondary outcomes
Operation time
Time frame: 1 day
Total number of retrieved lymph nodes
Time frame: 1 day
Noncompliance rate of lymph node dissection
Time frame: 1 day
Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A
Time frame: 1 day
Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)
Time frame: 1 day
Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)
Time frame: 1 day
Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)
Time frame: 1 day
Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)
Time frame: 1 day
Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B
Time frame: 1 day
Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)
Time frame: 1 day
Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)
Time frame: 1 day
Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)
Time frame: 1 day
Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)
Time frame: 1 day
Number of metastatic lymph nodes
Time frame: 1 day
Metastasis rate of lymph nodes
Time frame: 1 day
Morbidity and mortality rates
Time frame: 30 day
3-year overall survival rate
Time frame: 3 years
3-year recurrence pattern
Time frame: 3 years
Postoperative recovery course
Time frame: 30 days
Intraoperative situation
Time frame: 30 days
Postoperative nutritional status
Time frame: 3 years
Inflammatory and immune response
Time frame: 30 days
Postoperative quality of life (measured by EQ-5D)
Time frame: preoperative, postoperative 1 month and postoperative 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- 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.
Chang-ming Huang principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection in people with Gastric Cancer and Surgery, run by Fujian Medical University 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 7 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 24 Jun 2024. 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. Some participants in this study may receive a placebo. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mi Lin (13459152658, silihuala@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival rate (time frame: 3 years). 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 24 Jun 2024.