An observational study in Gastric Cancer and Surgery, sponsored by Fujian Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Fujian Medical University · Observational
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.
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's planned enrollment of 760 is above the median of 281 across 684 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Fujian Medical University is the lead sponsor of 148 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
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
ICG with D2+ group
Procedure: beyond D2 regional lymph node dissection
ICG with D2 group
Procedure: beyond D2 regional lymph node dissection
dissect the lymph nodes outside the extent of D2 LN region.
3-year disease free survival rate
Disease-free survival is calculated from the day of surgery to the day of recurrence or death
Time frame: 3 years
Total number of retrieved lymph nodes
Total number of retrieved lymph nodes
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 30 days
Number of metastatic lymph nodes
Number of metastatic lymph nodes
Time frame: 30 days
Metastasis rate of lymph nodes
Metastasis rate of lymph nodes
Time frame: 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.
Time frame: 30 days
Mortality rates
Patient died during hospitalization.
Time frame: 30 days
3-year overall survival rate
3-year overall survival rate
Time frame: 3 years
3-year recurrence pattern
3-year recurrence pattern
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 7 days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Apr 2027, 23 months later.
Of 274 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 171. This study's planned 23 months is below that.
Counting every sponsor, half of 305 studies reached it within 56 months; a quarter within 30 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
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