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Evaluation of the Efficacy for Sentinel Lymph Node Policy in Intermediate-risk Endometrial Carcinomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677024
Recruitment Status : Withdrawn (This study was not approved by the Ethics Committee)
First Posted : September 19, 2018
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaojun Chen, Fudan University

Brief Summary:
To evaluate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas

Condition or disease Intervention/treatment Phase
Endometrial Endometrioid Adenocarcinoma Procedure: SLN arm Not Applicable

Detailed Description:

Surgical assessment for staging of endometrial carcinoma during primary surgery remains one of the most varied practices worldwide, as it may include no nodal assessment, sentinel node mapping, and complete pelvic and aortic lymphadenectomy up to the renal vessels. Since lymphadenectomy is significantly associated with longer operating time, higher surgical costs, greater rate of infection, as well as the occurrence of lymphocysts and lymphedema, gynecologists agree that pelvic and aortic lymphadenectomy should be routinely performed in high-risk patients (grade 3, deep myometrial invasion, type 2 cancer). However, whether lymphadenectomy is required in patients with endometrioid endometrial cancers of grade 1 or 2 and with less than 50% myometrial invasion is controversial. Then, the investigators conducted this prospective cohort study to investigate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas (grade 1 or 2, < 50% myometrial invasion, and a tumor diameter ≥ 2 cm) as well as their outcomes.

Surgery should be performed within a maximum of 4 weeks from the patient's first consultation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy for Sentinel Lymph Node Policy in Intermediate-risk Endometrial Carcinomas
Estimated Study Start Date : February 6, 2020
Estimated Primary Completion Date : October 7, 2021
Estimated Study Completion Date : October 7, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SLN arm

Experimental:

  1. Intra-operative sentinel lymph node (SLN) mapping with indocyanin 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 proceeds to a total hysterectomy.

If only unilateral SLN are detected, surgeons will proceed to pelvic lymphadenectomy on the opposite side.

If non SLN are detected, surgeons will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic lymphadenectomy.

Procedure: SLN arm
Intra-operative SN mapping with indocyanin 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 another 1ml will be injected superficially (2mm-depth). The time between the injection and the search for SLN must be as soon as possible.

No Intervention: Lymphadenectomy arm
Surgeons will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic lymphadenectomy.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 1 years after the surgery ]
    Comparison of the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc.

  2. Recurrence rate [ Time Frame: 5 years after the surgery ]
    The recurrence rate of different groups will be followed up.

  3. Adjuvant therapy rate [ Time Frame: 5 years after the surgery ]
    The adjuvant therapy rate of different groups will be followed up.

  4. 5-year survival rate [ Time Frame: 5 years after the surgery ]
    The 5-year survival rate of different groups will be followed up.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. No contraindication to surgery.
  3. Signed and dated informed consent.
  4. Intermediate-risk endometrioid cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations).
  5. Without any suspicious pelvic, paraaortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/PET-CT.

Exclusion Criteria:

  1. Low-risk endometrioid cancer with grade 1-2, superficial myometrial invasion and tumor diameter < 2cm (in intraoperative frozen section examinations).
  2. Grade 3 endometrioid cancer (in preoperative pathological diagnosis or in intraoperative frozen section examinations).
  3. Deep muscular infiltration (in intraoperative frozen section examinations).
  4. Cervical invasion and/or ovarian/tubal invasion (in intraoperative frozen section examinations).
  5. With suspicious pelvic, paraaortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/PET-CT.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677024


Locations
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China, Shanghai
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xiaojun Chen, PhD Obstetrics and Gynecology Hospital, Fudan University
Publications:

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Responsible Party: Xiaojun Chen, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT03677024    
Other Study ID Numbers: 53201012
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaojun Chen, Fudan University:
Sentinel lymph node policy
Additional relevant MeSH terms:
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Endometrial Neoplasms
Carcinoma, Endometrioid
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases