Gastric CancerNCT06945718
Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Extended Lymphadenectomy Beyond D2 for Locally Advanced Gastric Cancer (FUGES-30)
An observational study of Gastric Cancer and Surgery, run by Fujian Medical University at 1 site in China.
Trial summary
Taking patients with locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond D2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not. 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?
- beyond D2 regional lymph node dissection
- Type of treatment
- Surgery or procedure
- How many people
- 760 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2030
- Phase
- Observational
- 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
Study population: 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
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 including enlarged or bulky lymph nodes in D3 region.
- Other malignant disease within the past 5 years 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 Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum 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, M.D., Ph.D., +86-133-6591-0253, hcmlr2002@163.com
Changming Huang, M.D., Ph.D.
About this study
Official title: Prospective Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With D2 Extra-regional Lymph Node Dissection for Locally Advanced Gastric Cancer (FUGES-30)
Taking patients with locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond D2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not.
- Conditions
- Gastric Cancer, Surgery
- Being tested
- beyond D2 regional lymph node dissection
- Keywords
- Gastric Cancer, Laparoscopic Gastrectomy, Indocyanine Green Tracer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beyond D2 regional lymph node dissectionProcedure or surgery
dissect the lymph nodes outside the extent of D2 LN region.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic gastrectomy with beyond D2 regional fluorescent lymph node dissection with ICG group | ICG with D2+ group Receives: Procedure: beyond D2 regional lymph node dissection | |
| laparoscopic gastrectomy with D2 regional lymph node dissection with ICG group | ICG with D2 group Receives: Procedure: beyond D2 regional 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 (21)
Total number of retrieved lymph nodes
Total number of retrieved lymph nodes
Measured: 30 days
Noncompliance rate of lymph node dissection
The LN dissection rate was determined by the number of patients in whom a LN station was harvested divided by the total number of patients who required retrieval at the corresponding LN station. Within the scope of D2 dissection, LN noncompliance was defined as the absence of LNs that should have been resected from > 1 LN station.
Measured: 30 days
Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A
Relationship between the number of fluorescent lymph nodes in group A and total number of lymph nodes in group A
Measured: 30 days
Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (True positive rate).
Measured: 30 days
Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)
The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (false positive rate).
Measured: 30 days
Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)
The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in group A (True negative rate).
Measured: 30 days
Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in Group A (false negative rate).
Measured: 30 days
Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B
Relationship between the number of fluorescent lymph nodes in group B and total number of lymph nodes in group B
Measured: 30 days
Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group B (True positive rate).
Measured: 30 days
Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)
The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (false positive rate).
Measured: 30 days
Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)
The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in group B (True negative rate).
Measured: 30 days
Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in Group B (false negative rate).
Measured: 30 days
Number of metastatic lymph nodes
Number of metastatic lymph nodes
Measured: 30 days
Metastasis rate of lymph nodes
Metastasis rate of lymph nodes
Measured: 30 days
Postoperative complications
Postoperative complications were evaluated within 30 days following surgery. These postoperative complications include gastrointestinal-related complications, incision-related complications, respiratory complications, cardiovascular and cerebrovascular complications, urinary system complications, infection complications, embolism complications, and other complications. The grading of postoperative complications adopts the Clavien-Dindo classification.
Measured: 30 days
Mortality rates
Patient died during hospitalization.
Measured: 30 days
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
Time to first flatus after surgery, time to first ambulation after surgery, time to first liquid diet after surgery, time to first semi-liquid diet after surgery, length of hospital stay after surgery.
Measured: 30 days
The incidence of intraoperative complications
Intraoperative complications were defined as bleeding due to named vessel injury, injury to visceral organs, mechanical factor-related problems, cardiopulmonary dysfunction due to hypercapnia, and other complications
Measured: 30 days
Inflammatory and immune response
the values of hemoglobin, prealbumin, albumin, C-reactive protein, and white blood cell count from peripheral blood before the operation and on postoperative day 1, 3, 5 are recorded.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2030 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 760 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
- Investigators
- Chang-Ming Huang, Prof., Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945718
- Sponsor's protocol ID
- FUGES-30
- Status last verified
- May 2025
- First submitted
- 21 Mar 2025
- Last updated
- 8 May 2025
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With D2 Extra-regional Lymph Node Dissection for Locally Advanced Gastric Cancer (FUGES-30)
- ClinicalTrials.gov ID
- NCT06945718
- Acronym / sponsor ID
- FUGES-30
- Conditions
- Gastric Cancer, Surgery
- Keywords
- Gastric Cancer, Laparoscopic Gastrectomy, Indocyanine Green Tracer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 25 Apr 2025 (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.
Taking patients with locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond D2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic gastrectomy with beyond D2 regional fluorescent lymph node dissection with ICG group | – | Procedure: beyond D2 regional lymph node dissectionICG with D2+ group |
| laparoscopic gastrectomy with D2 regional lymph node dissection with ICG group | – | Procedure: beyond D2 regional lymph node dissectionICG with D2 group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 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 ASA (American Society of Anesthesiology) class I to III Written informed consent
Key exclusion criteria (2 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 including enlarged or bulky lymph nodes in D3 region.
- Other malignant disease within the past 5 years 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 Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum History of an iodine allergy Patients who declined laparoscopic surgery
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 |
|---|---|---|
| beyond D2 regional lymph node dissectiondissect the lymph nodes outside the extent of D2 LN region. | Procedure or surgery | laparoscopic gastrectomy with D2 regional lymph node dissection with ICG group, laparoscopic gastrectomy with beyond D2 regional fluorescent lymph node dissection with ICG group |
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
21 secondary outcomes
Total number of retrieved lymph nodes
Time frame: 30 days
Noncompliance rate of lymph node dissection
Time frame: 30 days
Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A
Time frame: 30 days
Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)
Time frame: 30 days
Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)
Time frame: 30 days
Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)
Time frame: 30 days
Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)
Time frame: 30 days
Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B
Time frame: 30 days
Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)
Time frame: 30 days
Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)
Time frame: 30 days
Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)
Time frame: 30 days
Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)
Time frame: 30 days
Number of metastatic lymph nodes
Time frame: 30 days
Metastasis rate of lymph nodes
Time frame: 30 days
Postoperative complications
Time frame: 30 days
Mortality rates
Time frame: 30 days
3-year overall survival rate
Time frame: 3 years
3-year recurrence pattern
Time frame: 3 years
Postoperative recovery course
Time frame: 30 days
The incidence of intraoperative complications
Time frame: 30 days
Inflammatory and immune response
Time frame: 7 days
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 8 May 2025.
- 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, Prof. 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?
An observational study of 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 1 inclusion and 2 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 8 May 2025. 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.
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, phD (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 8 May 2025.