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Completed

NCT Number: NCT04302714

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a multicenter prospective randomized study

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

About this study

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent from the patient;
  • Histological diagnosis of endometrial cancer (including type I and II EC);
  • Early stage (FIGO stage < 4);
  • Age older than 18 years.

Exclusion criteria

  • Preoperative diagnosis of extra-uterine disease;
  • Preoperative suspicious of gross positive nodes;
  • Execution of neoadjuvant chemotherapy;
  • Contraindication to upfront general anesthesia and or mini-invasive surgery;
  • Systemic infections ongoing;
  • Pregnancy ongoing.

Treatment and study plan

Hysteroscopic injection

Procedure

Hysteroscopic injection

Cervical injection

Procedure

Cervical injection

Primary outcomes

  1. Detection rate

    Time frame: 30 month

    assessment of Detection rate in the para-aortic area

Secondary outcomes

  1. Detection rate

    Time frame: 30 month

    Detection rate in the pelvic area

  2. Operative time

    Time frame: 30 month

    Operative time to detect and remove sentinel node

  3. Intraoperative complications

    Time frame: 30 month

    Intraoperative complications during the sentinel lymph node dissection

  4. Postoperative complications

    Time frame: 30 month

    Postoperative complications graded per the Clavien-Dindo Classification system

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study title

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a Multicenter Prospective Randomized Study

Acronym: SLN_EC

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 10, 2020
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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