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Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma

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ClinicalTrials.gov Identifier: NCT03716414
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaojun Chen, Fudan University

Tracking Information
First Submitted Date October 21, 2018
First Posted Date October 23, 2018
Last Update Posted Date February 18, 2020
Actual Study Start Date November 1, 2018
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2018)
Performance Analysis [ Time Frame: Within 14 days after the surgery ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 21, 2018)
  • Postoperative complications [ Time Frame: 1 years after the surgery ]
    calculate the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc.
  • Recurrence rate [ Time Frame: 5 years after the surgery ]
    The recurrence rate will be followed up.
  • Adjuvant therapy rate [ Time Frame: 5 years after the surgery ]
    The adjuvant therapy rate will be followed up.
  • 5-year survival rate [ Time Frame: 5 years after the surgery ]
    The 5-year survival rate will be followed up.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
Official Title Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
Brief Summary 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).
Detailed Description Comprehensive surgical staging for endometrial carcinoma(EC) is an indisputable staging and prognostic tool. The staging procedure includes total hysterectomy, bilateral salpingo-oophorectomy, and lymphadenectomy, omental biopsy if necessary. Since lymph node metastasis is one of the most important risk factors of prognosis. The dissection of lymph nodes has been used for staging, prognostic information, and to determine the need for adjuvant therapy. The approach to lymph node evaluation in women with EC is still a subject of debate. Practice varies across different institutions or surgeons. In general, the options for management of retroperitoneal lymph nodes include no lymph node dissection (LND), systematic LND only if the risk of lymph node metastasis exceeds a certain threshold, or routine sentinel LND following lymphatic mapping. lymphadenectomy is significantly associated with longer operating time, higher surgical costs, greater rate of infection, as well as the occurrence of lymphocysts and lymphedema, moreover, there is lack of evidence of a therapeutic benefit of LND, less invasive techniques have emerged as possible alternatives. The technique for lymphatic mapping and sentinel lymph node dissection (SLND) in EC has been refined and found a low false-negative rate for detection of positive lymph nodes. The 2018 National Comprehensive cancer Network (NCCN) guideline of uterus cancer states SLN mapping can be considered for the surgical staging of apparent uterine-confined malignancy when there is no metastasis demonstrated by imaging studies or no obvious extrauterine disease at exploration. It indicates low-risk patients could avoid those side effects of the systematic Lymph node dissection. Whether high-risk patients (grade 3, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion) can be benefited from this technique? This prospective cohort study is designed to To evaluate the efficacy of sentinel lymph node biopsy technique in patients with high-risk endometrial carcinoma. Surgery should be performed within a maximum of 4 weeks from the patient's first consultation.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients aged 18-100 years old with high-risk endometrial carcinoma (grade 3 endometroid endometrial cancer, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion (in intraoperative frozen section examinations) and without no contraindication to surgery will be recruited.
Condition Endometrial Adenocarcinoma
Intervention Procedure: SLN mapping

Intra-operative SLN mapping with indocyanine green: Intracervical injection will be performed by the surgeon. Sub-mucous injections will be performed with 50% diluted dye at 3 and 9 o'clock positions. 1ml injection contained infracyanine green will be injected deeply into the stroma of the cervix (1cm-depth), and Arms Assigned Interventions another 1ml will be injected superficially (2mm-depth).

The time between the injection and the search for SLN must be as soon as possible.

Study Groups/Cohorts Experimental SLN arm

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.

Intervention: Procedure: SLN mapping
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 21, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xiaojun Chen, Ph.D. +86 021-33189900 ext 8370 cxjlhjj@163.com
Contact: Chao Wang, Ph.D. +86 021-33189900 ext 8370 wang1980-55@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03716414
Other Study ID Numbers 53201016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Xiaojun Chen, Fudan University
Study Sponsor Fudan University
Collaborators Not Provided
Investigators
Study Director: Chao Wang, Ph.D. Obstetrics and Gynecology Hospital, Fudan University
Principal Investigator: Xuezhen Luo, Ph.D. Obstetrics and Gynecology Hospital, Fudan University
Study Chair: Xiaojun Chen, Ph.D. Obstetrics and Gynecology Hospital, Fudan University
PRS Account Fudan University
Verification Date February 2020