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This study is a single-arm, open, multicenter, exploratory clinical study to evaluate the feasibility, sensitivity, and specificity of sentinel lymph node (SLN) mapping technology in the population with early epithelial ovarian cancer in China. Patients with stage I-II epithelial ovarian cancer evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning) are selected as the study population. The feasibility and value of SLN mapping technology in early epithelial ovarian cancer are explored through the location and number of sentinel lymph nodes, lymph node metastasis rate, 3-year disease-free survival rate, and the incidence of postoperative lower limb edema. The study plans to recruit 246 subjects. All subjects will receive study treatment after signing the informed consent form and passing the screening.
This clinical study is an evaluation of surgical method improvement. The standard surgical procedure includes: selecting patients who meet the inclusion criteria, completing preoperative examinations, having thorough preoperative communication, determining laparoscopic surgery and open surgery according to the patient's condition and examinations, mainly using open surgery and strictly screening laparoscopic surgery; carefully exploring the pelvic and abdominal peritoneum and the surface of abdominal organs during the operation, evaluating whether there is lymph node enlargement in the retroperitoneum, taking ascites or peritoneal lavage fluid, after removing the patient's adnexa, sending it for rapid pathology. After the pathology is confirmed to be epithelial cancer, select a fine needle to inject 2 ml of ICG (1.25 mg/ml) respectively into the residual end of the suspensory ligament and proper ligament of the affected side. If there are lesions on both adnexa, inject on both sides; open the retroperitoneum and open the peritoneum upward to reach the level of the left renal vein; observe the lymphatic drainage area, separate the lymph and adipose tissue along the blood vessels, and look for the visualized lymph nodes; send the resected visualized lymph nodes for intraoperative rapid pathology; after resecting the visualized sentinel lymph nodes, perform systematic lymph node resection (including the para-aortic lymph nodes below the left renal vein and bilateral pelvic lymph nodes); resect the greater omentum, perform biopsy and/or resect any suspicious lesions, and perform random biopsy of normal peritoneum; resect the total uterus and suture the vaginal stump; conduct postoperative follow-up and collect statistics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymph node developing group | Experimental | After injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected. |
|
| lymph node non-developing group | Experimental | After injecting IGG intraoperatively, the developing lymph nodes and systemic lymph nodes are resected |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymph node visualization | Procedure | Resect the developing lymph nodes and the systematic lymph nodes. Conduct postoperative follow-up and pay attention to the relevant indicators of the patient after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-Free Survival (PFS) is defined as the time interval between the patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause. | three years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival (OS) was defined as the time interval between the patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date. | three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen / Shen, MMed | Contact | +86551-13956005872 | doctorsz0311@163.com |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| No visualization of lymph nodes | Procedure | Resect the systematic lymph nodes. Conduct postoperative follow-up and pay attention to the relevant indicators of the patient after surgery. |
|
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |