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

NCT03716414 | Completed

• 1 other identifier: 53201016
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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).

Conditions

Endometrial Adenocarcinoma

Keywords

Sentinel lymph node

Outcome Measures

Primary Outcomes (1)

• Performance Analysis

  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.

  Within 14 days after the surgery

Secondary Outcomes (4)

• Postoperative complications

  1 years after the surgery

• Recurrence rate

  5 years after the surgery

• Adjuvant therapy rate

  5 years after the surgery

• 5-year survival rate

  5 years after the surgery

Study Arms (1)

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.

Procedure: SLN mapping

Interventions

SLN mapping PROCEDURE

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.

Experimental SLN arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age: 18\~100 years.
• No contraindication to surgery.
• Signed and dated informed consent.
• high-risk endometrial cancer with grade 3, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion (in intraoperative frozen section examinations).
• With any suspicious pelvic, para-aortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/positron emission computed tomography(PET)-CT.

You may not qualify if:

• Low-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter \< 2cm (in intraoperative frozen section examinations).
• Intermediate-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, China

Location

Study Officials

• Chao Wang, Ph.D.

  Obstetrics and Gynecology Hospital, Fudan University

  STUDY DIRECTOR

• Xuezhen Luo, Ph.D.

  Obstetrics and Gynecology Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

• Xiaojun Chen, Ph.D.

  Obstetrics and Gynecology Hospital, Fudan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 23, 2018
• Study Start: November 1, 2018
• Primary Completion: February 16, 2020
• Study Completion: February 16, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

CN (1)