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Hysterosonographically Guided Endometrial Biopsy

Technical Feasibility

¹ Department of Radiology, University of Washington, Harborview Medical Center, Box 359728, 325 Ninth Ave., Seattle, WA 98104.
² Department of Obstetrics and Gynecology, University of Washington, Harborview Medical Center, Seattle, WA 98104.

Received August 30, 1999; accepted after revision October 13, 1999.

 
Address correspondence to T. J. Dubinsky.

Introduction

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Vaginal bleeding is one of the most frequent reasons women seek health care [1], and the cause, usually benign, is often atrophy, polyps, or fibroids. Women undergo endometrial biopsy to exclude endometrial carcinoma, which has a reported incidence of 5-17% in perimenopausal and postmenopausal women with vaginal bleeding [2]. A variety of biopsy devices are available, but office-based biopsy procedures are uncomfortable [3], are nondiagnostic in 50% of cases [4], and can miss focal mass lesions including polyps and carcinoma [5]. In the last 10 years, endovaginal sonography has been widely used to evaluate the endometrium of women with vaginal bleeding [6], and saline-infusion hysterosonography has helped in the further evaluation of women who have abnormal endometrial findings on endovaginal sonography [7]. Hysterosonography improves the specificity of endovaginal sonography by excluding focal abnormalities when the endometrium appears thickened [8]. If endometrial biopsy could be performed using the hysterosonography catheter, images of the endometrium and tissue specimens could be obtained under visual guidance with a single catheterization of the cervix. Toward this goal, we tested a variety of catheters and biopsy devices to determine the feasibility of performing hysterosonographically guided endometrial biopsy through a single catheter.

Materials and Methods

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With our human subjects committee's approval, 14 women (age range, 32-65 years; mean, 48 years) with abnormal uterine bleeding consented to undergo hysterosonographically guided endometrial biopsy at the time of hysterosonography. The procedures were performed from March 1998 to March 1999 by radiologists and gynecologists in an outpatient treatment room located in the women's clinic of Harborview Medical Center.

All women underwent endovaginal sonography with a Prima (Siemens, Redmond, WA), an HDI 3000 (Applied Technologies Laboratories, Bothell, WA), or a Logiq 700 (General Electric Medical Systems, Milwaukee, WI) scanner and 5-MHz or multifrequency endovaginal transducers. The double-layer endometrial thickness was measured in the sagittal plane. Perimenopausal and postmenopausal women with a thickened endometrium, defined as greater than 5 mm, and premenopausal women with an endometrium thicker than 16 mm underwent hysterosonography using one of the following catheters: a 9-French Selecta-Cath System cervical-access catheter (Ackrad Laboratories, Cranford, NJ), a 12-French balloon cervical cannula (Cook OB/GYN, Spencer, IN), or a 9- or 12-French balloon cervical-access prototype designed specifically for hysterosonographically guided endometrial biopsy procedures (Cook OB/GYN). The first two cervical-access catheters were tested with and without the inner coaxial-guidance catheters (packaged for cannulation of the fallopian tubes).

We placed these catheters in the cervix using the standard procedure described for hysterosonography [5]. Although many women had endometrial thickening on endovaginal sonography, the only women we included in this series were those with focal or diffuse endometrial thickening on hysterosonography, and it is these women who subsequently underwent guided biopsy. We did not attempt to biopsy focal mass lesions such as polyps or fibroids, and we did not include women with these findings in this series. We gave no antibiotics prophylactically.

We biopsied the endometrium by placing a 5-French flexible biopsy forceps (Cook OB/GYN) coaxially through the cervix. Each combination of catheter and biopsy device was evaluated for adequacy of control of uterine distention, visibility under sonographic guidance, steerability, and success in obtaining an adequate specimen.

All women undergoing a biopsy received a paracervical block using lidocaine. After the hysterosonography and biopsy procedure, the gynecologist performed aspiration curettage using a 7-mm sterile vacuum curette (Synemed, Berkeley, CA) to completely evacuate the uterus. Endometrial hysterosonographically guided biopsy specimens were placed in formalin containers separate from those obtained with the vacuum curette so the specimens could be compared. The curettage specimens served as the control against which the flexible-forceps specimens were compared. We administered conscious IV sedation, including 1 mg of midazolam and 50 µg of fentanyl citrate, to all the women.

Results

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Adequate specimens were obtained in 13 of the 14 women. Three specimens were obtained from each patient. The time for the hysterosonography and biopsy was 10-15 min. In 13 women, the samples obtained at vacuum curettage showed the same histologic findings as those obtained with the forceps, including three hyperplasia, five secretory endometria, and five proliferative endometria. The three women with hyperplasia had multiple areas of focal endometrial thickening, and the remaining 10 had diffuse endometrial thickening. The 14th patient had endometrial carcinoma that was readily apparent on hysterosonography as marked focal thickening of the endometrium. This patient was obese, and her uterus was markedly anteflexed. We could not direct the forceps toward the cancer; hence, an adequate specimen could not be obtained. No complications occurred in any of the women undergoing this procedure.

Discussion

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We encountered numerous difficulties with the various catheters with and without concurrent use of guidance catheters. Coaxial catheter systems tended to leak saline during infusion hysterosonography. Even after having the manufacturers add valves to the catheters, uterine distention was often inadequate because of leakage. Poor distention resulted in poor visualization of the biopsy devices and inability to steer them to obtain biopsy specimens from focally thickened endometria. Hence, none of the commercially available cervical-access and hysterosonography catheters proved adequate for performing hysterosonographically guided biopsies. The best distention was achieved and maintained using a solitary catheter prototype manufactured by Cook OB/GYN and placing the biopsy device through it without the use of a coaxial guidance catheter.

The flexible forceps were readily visible (Fig. 1A). With the uterus empty of saline, the forceps were still quite visible (Fig. 1B). Visualization was important for guiding the device to the correct site for the biopsy and for determining when the device had been advanced to the end of the catheter to be free within the endometrial canal. No complications occurred during the biopsy procedures.

View larger version (154K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 1A. —43-year-old woman with abnormal uterine bleeding. Mid sagittal image obtained from videotape of procedure showing balloon catheter (straight open arrow) in uterus. Flexible forceps appear as echogenic line within catheter (curved arrows), and end of grasper appears as focal echogenicity located at fundus (straight solid arrow).

View larger version (161K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 1B. —43-year-old woman with abnormal uterine bleeding. Transverse image shows echogenic flexible forceps that produce posterior acoustic shadowing (arrow).

The biopsy device we tested, flexible forceps, cannot be steered independently. It requires an external catheter to guide it to the area of the endometrial abnormality. The catheters we tested initially were all straight, which restricted their ability to direct the biopsy device. Depending on uterine position, only the fundus could be biopsied. This was not important when the endometrium was diffusely thickened as in the patients with hyperplasia. In the one patient with endometrial carcinoma, the forceps could not be steered to the mass.

Our pathologists found that the biopsy specimens obtained with the flexible forceps led to the correct diagnosis as often as those obtained with endometrial biopsies, although we did not directly compare such specimens in this study. All the pathologists agreed that a typical specimen (Fig. 1C) was more than adequate to exclude carcinoma. A solitary specimen obtained with the forceps yielded adequate material for interpretation in each case, yet we have not proven how many samples should be obtained to adequately evaluate the endometrium.

View larger version (113K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 1C. —43-year-old woman with abnormal uterine bleeding. Photomicrograph of biopsy specimen obtained with flexible forceps shows normal proliferative endometrium. (H and E, x40)

Our study was designed so that each woman could undergo a hysterosonographically guided biopsy followed by a more invasive vacuum curettage. It has not been established whether such vacuum curetting is necessary in most cases, and questions remain regarding the proper amount of sedation and analgesia for this procedure. For this study, vacuum curettage provided comparison for our hysterosonographic biopsy samples. We have not proven that hysterosonographically guided endometrial biopsies can be performed routinely as an outpatient procedure without the use of sedation and local anesthesia. With smaller catheters this may be possible.

It would be useful if a woman shown to have both diffuse and particularly focal endometrial thickening on hysterosonography (which we have previously shown to be associated with an increased risk for malignancy [8]) could undergo a biopsy using the same catheter. This would save the patient a second procedure and ensure that the appropriate site had been sampled. Although polypectomies could probably be performed in this manner, the amount of pain associated with this procedure without general anesthesia may be unacceptable, and further investigation into the clinical feasibility of outpatient polypectomy is needed.

We have shown that it is technically feasible to perform hysterosonographically guided endometrial biopsies, but further redesign of existing catheters would be necessary to make this clinically applicable, particularly in outpatients.

Acknowledgments
 
We thank Brent Lopez for manuscript preparation and David Green and Colleen Elerick for their invaluable help with this project.

References

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1. Nand SL, Webster MA, Baber R, et al. Bleeding pattern and endometrial changes during continuous combined hormone replacement therapy. Obstet Gynecol 1998;91:678 -684[Abstract]
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3. Stovall TG, Photopulos GJ, Poston WM, Ling FW, Sandles LG. Pipelle endometrial sampling in patients with known endometrial carcinoma. Obstet Gynecol 1991;77:954 -956[Abstract/Free Full Text]
4. Weber A. Belinson J, Bradley L, Piedmonte M. Vaginal ultrasonography versus endometrial biopsy in women with postmenopausal bleeding. Am J Obstet Gynecol 1997;177:924 -929[Medline]
5. Dubinsky TJ, Parvey HR, Gormaz G, Curtis M, Maklad N. Transvaginal hysterosonography: comparison with biopsy in the evaluation of postmenopausal bleeding. J Ultrasound Med 1995;14:887 -893[Abstract]
6. Goldstein SR, Nachtigall M, Synder JR, Nachtigall L. Endometrial assessment by vaginal ultrasonography before endometrial sampling in patients with postmenopausal bleeding. Am J Obstet Gynecol 1990;163:119 -123[Medline]
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8. Dubinsky TJ, Stroehlein K, Abu-Ghazzeh Y, Parvey HR, Maklad N. Prediction of benign and malignant endometrial disease: hysterosonographic-pathologic correlation. Radiology 1999;210:393 -397[Abstract/Free Full Text]

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This Article Figures Only Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Dubinsky, T. J. Articles by Hoffer, E. K. Search for Related Content PubMed PubMed Citation Articles by Dubinsky, T. J. Articles by Hoffer, E. K. Social Bookmarking                      What's this?