Study of Instillation Technique Using The Modified Intra- Uterine Manipulator Catheter With Methylene Blue, Isosulfan Blue or Indocyanine Green Dyes, Compared to Cervical Injection, For Sentinel Lymph Node Detection in Endometrial Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of sentinel nodes detected by each method.
研究概览
简要总结
The purpose of this study is to compare the Instillation Technique Using The Modified Intra- Uterine Manipulator Catheter With Methylene Blue, Isosulfan Blue or Indocyanine Green Dyes, Compared to Cervical Injection, For Sentinel Lymph Node Detection in Endometrial Carcinoma.
详细描述
Following consent, surgery will be determined by the physician thereby determining group assignment- i.e the laparoscopic surgery group oror the robotic assisted surgery group. Both groups will undergo SLN mapping by instillation and injection. The Laparotomy/Laparoscopy Group will have Lymphazurin by injection and instillation of methylene blue dye. The Robot Assisted Group will have ICG by injection and instillation of methylene blue. Patients will undergo total hysterectomy, bilateral salpingoophorectomy, pelvic and paraaortic lymphadenectomy through laparotomy, laparoscopic or robotic assisted surgery as clinically determined by their attending physician. Subjects will undergo this surgery whether or not enrolled in the study.
Any clinically indicated uterine manipulator will be acceptable. Potential subjects will be informed of the potential risks of this device so they may make an informed decision about participation in the study. However the manipulator is standard of care and is not a study related risk. Subjects who agree to this study procedure will be monitored for adverse events.
The dyes used in this study are commercially available and will be provided through internal funding from the CTCA Gynecology/Oncology Department. Potential subjects will be informed
of the potential risks of these drugs so they may make an informed decision about participation in the study. Subjects who agree to this study procedure will be monitored for adverse events.
After administration of anesthesia, the intra-uterine uterine manipulator catheter will be inserted using the following suggested instructions for use;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 18 years old at the time of consent.
- •Preoperatively diagnosed endometrial carcinoma of any stage or grade and planned to undergo surgery (laparotomy, laparoscopy or robotic assisted) at IUSCC.
- •Medically operable status.
- •Ability to understand and willingness to sign a written informed consent and authorization for the release of health information.
排除标准
- •Previous radiotherapy.
- •Previous retroperitoneal surgery.
- •Significant physical limitations preventing proper vaginal examination as determined by the treating physician.
- •Personal history of allergy to iodides, iodine or shellfish.
- •No clinical indication for intra-uterine manipulator use.
研究组 & 干预措施
Standard of Care Sentinal Node Dye
Surgery route, as determined by the patient and clinician, will determine which standard clinical dye will be used.
干预措施: Standard of Care Sentinal Node Dye (Procedure)
Installation of Study Sentinal Node Dye
Surgery route, as determined by the patient and clinician, will determine which study dye will be used for delivery by the experimental route.
干预措施: Study Sentinal Node Dye (Procedure)
结局指标
主要结局
Number of sentinel nodes detected by each method.
时间窗: 1 Year
To determine if the new procedure is better than the current method of sentinal node detection. We will determine which dye and which route is most sensitive for detected metastatic cancer. Each Sentinel node dye and route will be compared to the full node dissection result.
次要结局
- Time to detection of 1st SN by each method.(1 year)
- Sensitivity of each method compared to full node dissection.(1 year)
