Clinical trial · Observational
Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
NCT03716414CI-TRIAL-00045649completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy of sentinel lymph node biopsy technique in patients with high-risk endometrial carcinoma, which provides the evidence that sentinel lymph node biopsy technique could substitute the systematic Lymph node dissection(LND).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SLN mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Experimental SLN arm
- description
- Experimental SLN arm 1. Intra-operative sentinel lymph node (SLN) mapping with indocyanine green injected into the stroma of the cervix. 2. Full bilateral laparoscopic lymphadenectomy and hysterectomy: If bilateral SLN are detected, all positive SLN will be removed. Then the surgeons proceed to a total hysterectomy, bilateral salpingo-oophorectomy, and lymphadenectomy including complete pelvic lymphadenectomy and aortic lymph node dissection. If only unilateral SLN or non SLN are detected, surgeons will proceed to complete pelvic lymphadenectomy and aortic lymph node dissection.
- interventionNames
- Procedure: SLN mapping
Primary outcomes (1)
- measure
- Performance Analysis
- timeFrame
- Within 14 days after the surgery
- description
- Using the final pathological diagnosis as the Gold Standard, the investigators will calculate the sensitivity, specificity, and predictive accuracy of mapping and detection of SLN with metastatic disease.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18\~100 years. 2. No contraindication to surgery. 3. Signed and dated informed consent. 4. high-risk endometrial cancer with grade 3, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion (in intraoperative frozen section examinations). 5. With any suspicious pelvic, para-aortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/positron emission computed tomography(PET)-CT. Exclusion Criteria: 1. Low-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter \< 2cm (in intraoperative frozen section examinations). 2. Intermediate-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations).
References
Publications (0)
Data not yet available
No reference posted for this study.