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

NCT03677024 | Withdrawn

• 1 other identifier: 53201012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Endometrioid Adenocarcinoma

Keywords

Sentinel lymph node policy

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 (2)

SLN arm

EXPERIMENTAL

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

Lymphadenectomy arm

NO INTERVENTION

Surgeons will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic lymphadenectomy.

Interventions

SLN arm PROCEDURE

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.

SLN arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (6)

• 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.

  PMID: 29061125 BACKGROUND

• 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.

  PMID: 27163153 BACKGROUND

• 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.

  PMID: 22910695 BACKGROUND

• 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.

  PMID: 22366409 BACKGROUND

• 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.

  PMID: 23839245 BACKGROUND

• Ballester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai 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.

  PMID: 21489874 BACKGROUND

Study Officials

• Xiaojun Chen, PhD

  Obstetrics and Gynecology Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 19, 2018
• Study Start: February 6, 2020
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)