Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding

All patients included in the study had single or multiple episodes of postmenopausal bleeding with an endometrial thickness of more than 5mm.

full history, general and local examination were done. Transvaginal ultrasound (TVS) was performed .The uterus was scanned in the sagittal plane. The double-layer ET was measured at the widest point between the endometrial-myometrial interfaces.the level of HE4 was measured. All women underwent hystrospopic guided endometrial biopsy. Definitive management was later performed in the form of total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection and histopathological examination.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Bleeding
• Intervention / Treatment: Procedure: Hysteroscopic guided fractional curretage; Procedure: total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection

Detailed Description

All patients included in the study had single or multiple episodes of postmenopausal bleeding with an endometrial thickness of more than 5mm.

Full history was taken , the number of episodes of postmenopausal bleeding, and previous investigations and current medications), general examination was performed and local examination was performed for all patients.

Transvaginal ultrasound (TVS) was performed .The uterus was scanned in the sagittal plane. The double-layer ET was measured at the widest point between the endometrial-myometrial interfaces by using electronic calipers. If there was fluid in the uterine cavity it was recorded. Suspected polyp was also recorded.

For the level of HE4: 5 ml of venous blood were withdrawn from all patients. The samples were left to clot. The separated sera were stored at -20˚ until all samples were obtained. Frozen samples were allowed to reach room temperature prior to use. Samples were then mixed thoroughly by gently inverting multiple times before analysis. HE4 was quantitatively assayed using the enzyme immunoassay (EIA) method (Fujirebio Diagnostics, Inc. Göteborg, Sweden). The functional sensitivity of the HE4 EIA is ≤ 25pM. The analytical specificity is 100 ± 15%.

All patients were then submitted to hysteroscopy under general anesthesia and endometrial biopsy.

After hysteroscopy and biopsy, 2 patient proved to have cervical malignancy, 2 patients were unfit for open surgery, and another 6 patients did not show up after. These 10 patients were excluded from the study leaving 90 patients eligible for final analysis .

Definitive management was later performed in the form of total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection and histopathological examination.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12111
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients with single or multiple episodes of postmenopausal bleeding Endometrial Thickness ≥ 5mm

Exclusion Criteria:

• • History of other Malignancies

  • Patients on chemo and/or radiotherapy
  • Patients on tamoxifen
  • Patients unfit for surgical intervention
  • Patients on HRT or other hormonal treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: post menopausal bleeding; women with postmenopausal bleeding and endometrial thickness more than 5 mm

Procedure: Hysteroscopic guided fractional curretage; Under general anaesthesia , evaluation of the endometrial cavity was done followed by biopsy of the whole endometrial tissue; Procedure: total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection; Through abdominal incision , removal of the whole uterus , both tubes and ovaries and in some cases pelvic lymph nodes removal was done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endometrial pathology	pathological examination of the endometrial tissue	3 days after hystroscopy

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (ACTUAL): June 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: 37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No