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L'essai clinique NCT06945718 pour Cancer gastrique, Chirurgie est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Université de médecine du FujianClinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Extended Lymphadenectomy Beyond D2 for Locally Advanced Gastric Cancer (FUGES-30)
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L'étude clinique NCT06945718 est un essai observationnel pour Cancer gastrique, Chirurgie. Son statut actuel est : en recrutement. L'étude a débuté le 1 mai 2025 et vise à recruter 760 participants. Dirigé par l'Université de médecine du Fujian, l'essai devrait être terminé d'ici le 1 mai 2030. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 8 mai 2025.
Résumé succinct
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.
Titre officiel
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)
Conditions
Cancer gastriqueChirurgieAutres identifiants de l'essai
- FUGES-30
Numéro NCT
Date de début (réel)
2025-05-01
Dernière mise à jour publiée
2025-05-08
Date de fin (estimée)
2030-05-01
Inscription (estimée)
760
Type d'essai
Observationnel
Statut
En recrutement
Mots clés
Gastric Cancer
Laparoscopic Gastrectomy
Indocyanine Green Tracer
Laparoscopic Gastrectomy
Indocyanine Green Tracer
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
laparoscopic gastrectomy with beyond D2 regional fluorescent lymph node dissection with ICG group ICG with D2+ group | Beyond D2 Regional LYMPH Node Dissection dissect the lymph nodes outside the extent of D2 LN region. |
laparoscopic gastrectomy with D2 regional lymph node dissection with ICG group ICG with D2 group | Beyond D2 Regional LYMPH Node Dissection dissect the lymph nodes outside the extent of D2 LN region. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
3-year disease free survival rate | Disease-free survival is calculated from the day of surgery to the day of recurrence or death | 3 years |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Total number of retrieved lymph nodes | Total number of retrieved lymph nodes | 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. | 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 | 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). | 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). | 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). | 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). | 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 | 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). | 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). | 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). | 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). | 30 days |
Number of metastatic lymph nodes | Number of metastatic lymph nodes | 30 days |
Metastasis rate of lymph nodes | Metastasis rate of lymph nodes | 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. | 30 days |
Mortality rates | Patient died during hospitalization. | 30 days |
3-year overall survival rate | 3-year overall survival rate | 3 years |
3-year recurrence pattern | 3-year recurrence pattern | 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. | 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 | 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. | 7 days |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
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
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
Université de médecine du Fujian309 essais cliniques actifs à explorerPartie responsable de l'essai
Chang-Ming Huang, Prof., Investigateur principal, Chief doctor, phD, FACS, Fujian Medical University
Contact central de l'essai
Contact: Mi Lin, phD, 13459152658, [email protected]
Contact: Hua-Long Zheng, phD, 18359190587, [email protected]
1 Centres de l'essai dans 1 pays
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
Changming Huang, M.D., Ph.D., Contact, +86-133-6591-0253, [email protected]
Changming Huang, M.D., Ph.D., Investigateur principal
En recrutement