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LUDEC Study - Pilot Study of the Lavage of the Uterine Cavity for the Diagnosis of Endometrial Carcinoma

NCT02387645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-02-13

No results posted yet for this study

Summary

The current pilot study aims at answering the scientific question, whether exfoliated cells from Endometrium Carcinoma (EC) can be detected in the lavage fluid from the uterine cavity and proximal fallopian tubes with the same sensitivity as in specimen from liquid-based cervical cytology. If this turns out to be the case, earlier detection, particularly of type II EC should be possible.

Conditions

  • Cancer of Endometrium
  • Carcinoma of Endometrium
  • Endometrial Neoplasms

Interventions

PROCEDURE

Lavage of the Uterus

The lavage will be performed in the operating theatre under general anesthesia. The ALPINE technique includes the following steps. A three way catheter (catheter for uterine and tubal lavage) is inserted into the cervical canal and a balloon is inflated to seal the cervical canal. The patient is put into anti-Trendellenburg positioning. Normal saline is slowly flushed into the uterine cavity and proximal tubes. After the lavage is finished, the balloon is deflated and the catheter is removed. A cap is put on the collection syringe and the syringe is sent to the laboratory.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Paul Speiser, Prof. Dr. med. · Medical University Vienna, Dptm. of Obstetrics & Gynaecology

  • Elisabeth Maritschnegg, MSc. · Medical University Vienna, Dptm. of Obstetrics & Gynaecology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-05-31
Completion
2018-03-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02387645 on ClinicalTrials.gov