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

Endometrial Endometrioid Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03677024
• Other study ID #: 53201012
• Status: Withdrawn
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: October 7, 2021

Study information

• Verified date: February 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Endometrioid
• Endometrial Endometrioid Adenocarcinoma
• Endometrial Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Obstetrics and Gynecology Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (6)

Ballester M, Dubernard G, Lécuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Daraï E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12. — View Citation

Barlin JN, Khoury-Collado F, Kim CH, Leitao MM Jr, Chi DS, Sonoda Y, Alektiar K, DeLair DF, Barakat RR, Abu-Rustum NR. The importance of applying a sentinel lymph node mapping algorithm in endometrial cancer staging: beyond removal of blue nodes. Gynecol Oncol. 2012 Jun;125(3):531-5. doi: 10.1016/j.ygyno.2012.02.021. Epub 2012 Feb 22. — View Citation

How J, Lau S, Press J, Ferenczy A, Pelmus M, Stern J, Probst S, Brin S, Drummond N, Gotlieb W. Accuracy of sentinel lymph node detection following intra-operative cervical injection for endometrial cancer: a prospective study. Gynecol Oncol. 2012 Nov;127(2):332-7. doi: 10.1016/j.ygyno.2012.08.018. Epub 2012 Aug 19. — View Citation

Vidal F, Leguevaque P, Motton S, Delotte J, Ferron G, Querleu D, Rafii A. Evaluation of the sentinel lymph node algorithm with blue dye labeling for early-stage endometrial cancer in a multicentric setting. Int J Gynecol Cancer. 2013 Sep;23(7):1237-43. doi: 10.1097/IGC.0b013e31829b1b98. — View Citation

Yang B, Shan B, Xue X, Wang H, Shan W, Ning C, Zhou Q, Chen X, Luo X. Predicting Lymph Node Metastasis in Endometrial Cancer Using Serum CA125 Combined with Immunohistochemical Markers PR and Ki67, and a Comparison with Other Prediction Models. PLoS One. 2016 May 10;11(5):e0155145. doi: 10.1371/journal.pone.0155145. eCollection 2016. — View Citation

Zhu M, Jia N, Huang F, Liu X, Zhao Y, Tao X, Jiang W, Li Q, Feng W. Whether intermediate-risk stage 1A, grade 1/2, endometrioid endometrial cancer patients with lesions larger than 2 cm warrant lymph node dissection? BMC Cancer. 2017 Oct 23;17(1):696. doi: 10.1186/s12885-017-3671-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative complications	Comparison of the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc.	1 years after the surgery
Secondary	Recurrence rate	The recurrence rate of different groups will be followed up.	5 years after the surgery
Secondary	Adjuvant therapy rate	The adjuvant therapy rate of different groups will be followed up.	5 years after the surgery
Secondary	5-year survival rate	The 5-year survival rate of different groups will be followed up.	5 years after the surgery