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Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination

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ClinicalTrials.gov Identifier: NCT03917147
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Pasquale De Franciscis, University of Campania "Luigi Vanvitelli"

Brief Summary:
A prospective cohort study at a Tertiary University Hospital. From January to December 2018, we enrolled women with the following criteria: abnormal uterine bleeding in post-menopause, endometrial thickening in pre-or post-menopause; tamoxifen usage. Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Senior operators had to foresee histopathological diagnosis using a questionnaire. Histopathological examination was conducted to confirm the diagnosis.

Condition or disease Intervention/treatment
Endometrial Hyperplasia Endometrial Neoplasms Procedure: Office Hysteroscopy

Detailed Description:

Patient underwent the procedure after the menstrual phase (day 6 to 10) of a spontaneous menstrual cycle. All the procedures were performed by means of a continuous flow small-diameter hysteroscope with oval profile (maximum diameter 5 mm, minimum diameter 3.9 mm) (Bettocchi Office Hysteroscope size 5, Karl Storz GmbH & Co., Tuttlingen, Germany) fitted with a 30-degree telescope of 2.9 mm gauge, using the vaginoscopic approach, without tenaculum and speculum, and using saline solution as distending medium at 90-100 mmHg pressure generated by a pneumatic cuff and measured by means of a manometer; the biopsies were performed with the "punch" or "grasp" technique using a 5 Fr grasping forceps inserted through the operating channel of the hysteroscope. In case of small intrauterine pathologies, they were easily removed by means of a straight bipolar electrode active by an electrosurgical generator (Versapoint II; Gynecare, Ethicon) used to provide a 50W power for the mildest vapour cutting mode (VC3).

The hysteroscopic diagnosis of hyperplasia was based on one or more of the following findings: (1) focal or diffuse, papillary or polypoid, endometrial thickening, (2) Abnormal vascular patterns; (3) evidence of glandular cysts; (4) abnormal architecture features of glandular outlets (thickening, irregular gland density, dilatation). Although no consensus or RCTs showed agreement in describing objective criteria for EH, several trials agreed on the previous morphologic evaluation. [8].

The procedures were taken by three senior gynaecologists (P.D.F, L.C., N.C) whose expertise and skills were equivalent. After every procedure, surgeons were asked to propose a suggestive histological categorization of the clinical diagnosis by means of a questionnaire, in order to standardize the assessment. The questionnaire was made of a progressive number which identified the biopsy and a multiple-choice question. Operators were asked to choose one from the following answers: Benign (including atrophic endometrium, proliferative endometrium, endometrial polyp/s); Endometrial Hyperplasia (simple or complex hyperplasia); Atypical Hyperplasia/Carcinoma (including atypical endometrial hyperplasia and adenocarcinoma) Biopsied histological samples were sent for histopathological analysis. The histopathological examination of all the specimens was performed at the Pathology Unit of University of Campania "Luigi Vanvitelli". Three senior gynecopathologists (INS), with the same skills and expertise, were addressed to evaluate all the biopsies

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Study Type : Observational
Actual Enrollment : 435 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination: a Prospective Cohort Study
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : December 9, 2018

Group/Cohort Intervention/treatment
AUB in Post-Menopause
Abnormal Uterine Bleeding (AUB) in Post-Menopause
Procedure: Office Hysteroscopy
Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Histopathological examination was conducted to confirm the diagnosis.

Endometrial Thickening in post-menopause
Ultrasonographic detection of Thickened Endometrium in post-menopause
Procedure: Office Hysteroscopy
Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Histopathological examination was conducted to confirm the diagnosis.

Endometrial Thickening in pre-menopause
Ultrasonographic detection of Thickened Endometrium in pre-menopause
Procedure: Office Hysteroscopy
Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Histopathological examination was conducted to confirm the diagnosis.

Pharmacological history of Tamoxifen-related therapy regimens
Patients who had been treated with Tamoxifen
Procedure: Office Hysteroscopy
Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Histopathological examination was conducted to confirm the diagnosis.




Primary Outcome Measures :
  1. Sensitivity For Endometrial Hyperplasia [ Time Frame: 12 months ]
  2. Correlation between histopathological and cllinical diagnosis for Endometrial Hyperplasia [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Negative Predictive value [ Time Frame: 12 months ]
  2. Positive Predictive value [ Time Frame: 12 months ]
  3. Likelihood ratio [ Time Frame: 12 months ]
  4. Positive and negative post test probability [ Time Frame: 12 months ]

Biospecimen Retention:   Samples Without DNA
Endometrial Biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women included in this study are referred by gynaecologists of the general outpatient rooms of the institution's hospital
Criteria

Inclusion Criteria:

  • abnormal uterine bleeding in post-menopause
  • ultrasonographic detection of endometrial thickening in pre-menopause
  • ultrasonographic detection of endometrial thickening in post-menopause
  • follow-up after Tamoxifen-based therapy regimens

Exclusion Criteria:

  • severe urinary symptoms
  • history of severe comorbidities (autoimmune disorders, chronic diseases and severe cardiac disease)

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): NCT03917147


Locations
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Italy
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
Naples, Italy, 80131
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Pasquale De Franciscis, Associate Professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03917147    
Other Study ID Numbers: N.592
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Prof. Pasquale De Franciscis, University of Campania "Luigi Vanvitelli":
Endometrial Hyperplasia
Office Hysteroscopy
Predictive values
Sensitivity
Additional relevant MeSH terms:
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Endometrial Neoplasms
Endometrial Hyperplasia
Hyperplasia
Pathologic Processes
Uterine Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms