Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination

Endometrial Neoplasms Clinical Trial

Official title:

Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917147
• Other study ID #: N.592
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: December 9, 2018

Study information

• Verified date: April 2023
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: December 9, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
Italy	Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Bourdel N, Chauvet P, Tognazza E, Pereira B, Botchorishvili R, Canis M. Sampling in Atypical Endometrial Hyperplasia: Which Method Results in the Lowest Underestimation of Endometrial Cancer? A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):692-701. doi: 10.1016/j.jmig.2016.03.017. Epub 2016 Apr 4. — View Citation

Ghoubara A, Sundar S, Ewies AAA. Predictors of malignancy in endometrial polyps: study of 421 women with postmenopausal bleeding. Climacteric. 2018 Feb;21(1):82-87. doi: 10.1080/13697137.2017.1410783. Epub 2017 Dec 8. — View Citation

Trimble CL, Kauderer J, Zaino R, Silverberg S, Lim PC, Burke JJ 2nd, Alberts D, Curtin J. Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial hyperplasia: a Gynecologic Oncology Group study. Cancer. 2006 Feb 15;106(4):812-9. doi: 10.1002/cncr.21650. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity For Endometrial Hyperplasia		12 months
Primary	Correlation between histopathological and cllinical diagnosis for Endometrial Hyperplasia		12 months
Secondary	Negative Predictive value		12 months
Secondary	Positive Predictive value		12 months
Secondary	Likelihood ratio		12 months
Secondary	Positive and negative post test probability		12 months