Comparison of Two-Point and Four-Point Cervical Injection Techniques Using Methylene Blue for Sentinel Lymph Node Mapping in Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sentinel Lymph Node (SLN) Detection Rate
研究概览
简要总结
This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success.
详细描述
In recent years, Sentinel Lymph Node (SLN) mapping has become a key focus in improving surgical outcomes for endometrial cancer. While methylene blue is a cost-effective option for SLN mapping, its detection rates remain suboptimal. This study aims to evaluate whether increasing the injection points from the standard 2-point to a 4-point methylene blue injection improves SLN mapping success.
This randomized controlled trial will include patients with preoperative stage I endometrial carcinoma. Participants will be randomized into two groups: one group will receive a 2-point methylene blue cervical injection, and the other group will receive a 4-point injection.
The primary endpoint is the difference in SLN detection rates between the two techniques. Findings from this study will provide detailed insights into whether the 4-point injection offers a significant advantage over the standard 2-point method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
To minimize bias and ensure the reliability of study results, both participants and care providers will be blinded to group allocation. The surgeon administering the injection and the pathologist evaluating lymph node samples will not be informed whether the participant received the two-point or four-point cervical injection. This double-masking approach enhances the objectivity of care delivery and outcome assessment, thereby strengthening the validity of the findings.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with stage I endometrial cancer based on CT and PET-CT imaging.
- •Individuals with a pathologically confirmed diagnosis of stage I endometrial cancer.
排除标准
- •Medical Conditions
- •Individuals diagnosed with dementia.
- •Individuals with allergies to methylene blue or iodine.
- •Individuals who have received active treatment for another malignancy within the past five years.
- •Inability to successfully perform PLD (pelvic lymphadenectomy) or history of prior PLD.
- •Women with multiple and confluent lymph nodes identified as positive on FDG-PET/CT (such cases are not considered stage I).
- •Cancer-Related Conditions
- •Individuals with clinically or radiologically identified positive lymph nodes or metastatic disease.
- •Individuals with a history of pelvic dissection and/or radiation therapy.
- •Individuals with advanced cervical or uterine cancer.
- •Individuals with T3/T4 lesions.
- •Individuals with cervical tumors larger than 2 cm.
- •Organ Dysfunction
- •Individuals with hepatic dysfunction and a MELD score ≥ 10 and creatinine ≥ 2·0 mg/dl patients.
研究组 & 干预措施
2- Point Methylene Blue Injection
In the 2-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix:
At the 3 o'clock position At the 9 o'clock position
干预措施: Sentinel Lymph Node Detection/Cervical Methylene Blue Injection (Procedure)
4- Point Methylene Blue Injection
In the 4-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix:
At the 2 o'clock position At the 4 o'clock position At the 8 o'clock position At the 10 o'clock position
干预措施: Sentinel Lymph Node Detection/Cervical Methylene Blue Injection (Procedure)
结局指标
主要结局
Sentinel Lymph Node (SLN) Detection Rate
时间窗: 1 day
The detection rate will be measured as the number of sentinel lymph nodes identified using methylene blue divided by the total number of lymph nodes excised during surgery. Comparison will be made between the two-point and four-point cervical injection techniques. (Unit of Measure: Proportion (%))
Sensitivity of SLN Biopsy for Detecting Lymph Node Metastases
时间窗: 1 day
Sensitivity will be calculated as the proportion of true positive SLNs (confirmed by histopathology) over the total number of lymph nodes with metastases. (Unit of Measure: Percentage (%))
Specificity of SLN Biopsy for Detecting Lymph Node Metastases
时间窗: 1 day
Description: Specificity will be calculated as the proportion of true negative SLNs over all lymph nodes without metastasis. (Unit of Measure: Percentage (%))
Rate of Positive SLNs Detected
时间窗: 1 day
Proportion of SLNs identified as positive for metastasis in each injection technique group. (Unit of Measure: Proportion (%))
次要结局
- Procedure Duration(1 day)
- Complications and Side Effects - Injection-Related Side Effects(1 month)
- SLN Anatomical Distribution(1 day)
- Surgical Complications(1 month)
研究者
İbrahim Yalçın
Principal Investigator
Dokuz Eylul University