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Role of pipelle versus dilatation and curettage in tissue diagnosis abnormal uterine bleeding

of women experience episodes of AUB at some point of time their lifetime. ABSTRACT Background: Menstrual irregularities and abnormal heavy menstruation account for up to 26-35% of women attending Gynecological outpatient Department. Abnormal Uterine Bleeding (AUB), it is more common at extremes of age endometrial hyperplasia occurs in 5-10% of patients with post-menopausal bleeding out of which atypical hyperplasia has 26-32 % risk of having malignancy in future. Therefore, endometrial sampling for histopathology is important in the assessment of abnormal uterine bleeding is mandatory. Our study was conductive to know the effectiveness of pipelle type devices, versus Dilatation and curettage in obtaining quality endometrial tissue for histopathological examination. Methods: The study was undertaken in Department of obstetrics and gynaecology along with department of Pathology at Rajarshi Chhatrapati Shahu Maharaj, government medical college, Kolhapur after getting approval from the Hospital Committee on Clinical Research and Ethical Committee of the institution, during the period from October 2016 to March 2017 (six months). Total number of subjects included in study is Hundred after taking into consideration of inclusion and exclusion criteria. Results: The ease of doing procedure was much easier as compared to D&C and the Tissue sample obtained for histopathological examination were as par D&C. It was concluded that histopathology report was available in 92 of the 100 pipelle samples and 93 of 100 D&C samples. It was also, observed that increased endometrial thickness was not always associated with adequate tissue diagnosis. Conclusions: Pipelle is simple, affordable, patient friendly can be easily performed with minimal training, which can be performed in Outpatient Gynaecological Department. The diagnostic value and positive predictive value of Pipelle is at par with conventional D&C. So, pipelle can be recommended for all perimenopausal patients with AUB to rule out various, premalignant and malignant conditions of the endometrium .


Menstrual
irregularities and abnormal heavy menstruation account for up to 26-35% of women attending Gynaecological outpatient Department.
Although women of any age group can be affected by Abnormal Uterine Bleeding (AUB), it is more common in the age group of 35-45 years of age. 1 About 10 -25% of women experience episodes of AUB at some point of time during their lifetime.
Setzler & colleagues found that 18% of peri-menopausal women had menorrhagia or metrorrhagia & one fifth of these were due to premalignant or malignant disease. 2 Endometrial hyperplasia occurs in 5-10% of patients with post-menopausal bleeding out of which atypical hyperplasia has 26-32 % risk of having malignancy in future. About 10% of patients with post-menopausal bleeding have endometrial cancer. Therefore, endometrial sampling for histopathology is important in the assessment of abnormal uterine bleeding is mandatory.
To date, hysteroscopic biopsy & D&C is considered as the standard for endometrial sampling without its place in gynaecology being challenged. There are various other methods which are less traumatic can be performed at ease and without anaesthesia to obtain quality samples for HPR examination.
Of the several office endometrial sampling methods, the Pipelle is a disposable polypropylene sheath with an inner plunger has been found to be very comfortable, patient friendly, can be done without anaesthesia and gave comparable histological findings from tissue obtained by D&C, hysterectomy or stiff metal curette. 3 This device can be used by anyone trained in the use of a uterine sound & is simpler than the insertion of an IUCD. 4 Pipelle enables quick sampling of endometrium (5-15 sec of operating time) and the entire procedure can be accomplished within 10-15 minutes. The safety & acceptability of this device has been reported in various studies & after successful use in tertiary care practice, it has been introduced into primary care. But there is still concern regarding obtaining the quality tissue endometrial sample by pipelle as compared to D&C. Though many studies have been reported about the effectiveness of pipelle type devices, very few studies are available from India. This study is being conducted to establish the validity and reliability in obtaining quality endometrial tissue for histopathological examination by pipelle. This study seeks to place D&C in its historical perspective and to chart the development of pipelle for sampling the endometrial lining of the uterus. The study was an observational correlation study. After assessment of inclusion and exclusion criteria, 100 cases of abnormal uterine bleeding patients were selected for the study. Thorough clinical assessment of the patient was performed in the outpatient department which included history, physical examination and baseline investigations.

The study was undertaken in
Transabdominal sonography was performed before taking an endometrial biopsy to avoid invasive procedures like transvaginal sonography. Routine Pap smear was performed in all cases.
Both the procedures were performed in Operation Theatre first pipelle curettage without anaesthesia followed by Dilatation and curettage under Anaesthesia. Both the procedures were performed in the same setting to maintain the synchronicity in the timing of samples and to prevent inconvenience to the patient. The two different samples after labelling were sent to the Histopathologist who was blinded regarding the method of sample collection for histopathology assessment.
The pipelle device used for sampling was by Gynetics medical products, Belgium.

RESULTS
This observational clinical correlation diagnostic study was designed to compare the efficiency of Pipelle endometrial sampling with dilatation and curettage in obtaining a sufficient quality endometrial sample for histopathological diagnosis.
The ease of the procedure (subjective assessment by the doctor who performed the procedure, taking into consideration the time taken to negotiate the cervix and sampling procedure as whole) and sample adequacy was then compared.
Pipelle sampling was termed not easy only in one case compared to 12 D&C cases, though the association was statistically not significant. There was no association between ease of pipelle sampling or sample adequacy with age or menopausal status.
In our study group, the maximum number of patients (37%) were noted in the age group of 41-45 years, followed by 29% in the age group 46-50 years. 24% of the study subjects were in the age group of 35-40 years and 10% of the subjects were more than 50 years.
In our study group 1-6 months duration of AUB was seen in 60% of the subjects, 6-12 months in 20%, more than 12 months of AUB in 9% of subjects and postmenopausal bleeding was seen in 11%.
In our study group, 8 patients were nulliparous and 92 patients were parous women. Of the parous women, 33% patients were Para 2, 29% patients were Para 3 and 26% of the patients were Para 5 and above. Of the 100 patients there was a past history of some medical illnesses noted in 42% of the subjects. Hypertension was the commonest of the medical illnesses noted, accounting to 22%, followed by Diabetes mellitus in 17% who were in some form of treatment at the time of admission. In our study group, 27% of patients were not sterilized and 73% were sterilized. None of the patients were using additional contraceptive methods other than barrier methods at the time of admission.
The sample was sufficient in 93% of patients in D&C sampling and 92% of patients in pipelle sampling. The most common endometrial pattern identified was proliferative phase endometrium (44%). Secretory phase endometrium was second most common (31%) followed by simple hyperplasia (9%), irregular shedding (3%), complex hyperplasia (3%), atypical complex hyperplasia (1%) disordered proliferative (1%), polyp (1%), atrophic endometrium (1%) and endometrial carcinoma (1%). The correlations might not be accurate as there was no standardized time interval between the TVS examination and tissue sampling. Moreover, some patients had bleeding at the time of admission, that might have accounted to the scanty sample despite thickened endometrium.

DISCUSSION
The most common presenting complaint in the premenopausal age group was menorrhagia, followed by polymenorrhagia, and prolonged bleeding following a period of amenorrhoea. Postmenopausal bleeding was noted in 11 subjects of the study group Ben Baruch et al reported that there was no significant correlation noted between age and success of sampling in relation to tissue obtained on histopathological examination with pipelle.
Out of the total 11 cases of Post-menopause in our study the total number of patients who had difficult D&C procedures were 4 out of 11, while no one had difficulty while performing the pipelle procedure.
Williams et al reported that nulliparity was significantly associated with insertion failure for Pipelle. 6 Insertion of pipelle was unsuccessful in 22% of attempts in nulliparous women compared with 8% parous women.
Tissue available was inadequate more in nulliparous women (25% inadequate rate) compared with parous women (5% inadequate rate). They found the effect of parity on adequacy of specimen is independent of device insertion failure, but no certain explanation was given.
Bakour et al reported that there was no association between adequate sample and parity using multivariate regression analysis model. 7 In our study, though it was expected that the procedure would be difficult in patients who were nulliparous but it was easy procedure in all nulliparous patients in our study. McCluggage reported about the artefacts in endometrial biopsy specimens, especially in outpatient sampling. Some of these may be misinterpreted as endometrial hyperplasia or even as carcinoma if not appreciated to be artefactual. Telescoping refers to glands within glands and is commonly seen.
Dijkhuizen et al, found that detection rate for endometrial carcinoma was higher in postmenopausal women compared with premenopausal women. In both postmenopausal and premenopausal women, the pipelle was the best device, the detection rates of 99.6% and 91% respectively.
In our study, there were 9 patients with simple hyperplasia, 2 patients with complex hyperplasia without atypia and 1 patient with complex hyperplasia with atypia. All samples of simple hyperplasia, complex hyperplasia without atypia and atypia were picked up by both pipelle and D&C patients. Also, we had one case of endometrial cancer which was accurately picked up by pipelle sampling technique which was confirmed by definitive surgery.
In another comparative study by Gloria. S et al (2007) undertaken to evaluate the ability of preoperative endometrial sampling to accurately diagnose high grade endometrial tumours, sensitivity of pipelle and curettage was 93.8% and 97% in patients with low grade cancer and 99.2% and 100% in patients with high grade cancer. Good agreement was observed between the preoperative and the hysterectomy histologic diagnosis (kappa=0.69), and between the preoperative and hysterectomy tumour grade. 10 In a study by Behnamer et al, the sample sufficiency of the two methods were comparable: 157 (94%) in pipelle vs. 156(93%) in D&C. 11 In pipelle study by Abera Choudary et al, the study revealed sample adequacy of 98%. 12 The only inadequate samples were from postmenopausal ladies with atrophic endometrium.
Bakour et al followed up 74 patients of 248 women who had insufficient tissue at pipelle endometrial sampling. None of them had endometrial cancer or hyperplasia. 7 Contrary to that Farrell and collegues demonstrated that, in postmenopausal women in whom the result of pipelle sampling was insufficient, 20% had uterine pathology after a second investigation. In 3% of cases this was malignant disease. 13 El sandabesee et al examined the factors that would affect the adequacy of endometrial samples in terms of their suitability for histopathological examination. He found that the ability to obtain an adequate endometrial sample was primarily affected by the endometrial thickness. There is only a 27% probability of getting an adequate endometrial sample in the group of women with an endometrial thickness of <5mm.
In our study, it was observed that increased endometrial thickness was not always associated with adequate tissue diagnosis. Of the 5 patients with endometrial thickness of 4 mm, adequate tissue for histopathological diagnosis was available in 4cases in pipelle and D&C as well. Scanty tissue was noted in 1 among 5 patients in both D&C and pipelle group. woman).
Gordon et al reported that endometrial polyps or submucous fibroids were found in half of the cases with an inadequate pipelle sample, where definitive histology was available. 14  The pipelle device picked up all cases of endometrial hyperplasia and 1 case of endometrial carcinoma. Thus, the predictive value of pipelle for diagnosing endometrial carcinoma and endometrial hyperplasia is percent compared to D&C in our study. No complications were noted in both D&C and pipelle sampling.

CONCLUSION
The following conclusion was derived from the study on diagnostic value of pipelle endometrial sampling versus Dilatation and Curettage in patients with abnormal uterine bleeding: Pipelle is simple, affordable, patient friendly which can be done in Outpatient Gynaecological Department. Thus, it can be considered as the gold standard for getting a sufficient quality endometrial tissue for Histopathological examination in AUB patients for early diagnosis of various premalignant and malignant conditions of the endometrium. Pipelle is also known to cause less cervical tissue damage compared to D&C, which is known to have better Obstetric outcome in future Pregnancy. The diagnostic value and positive predictive value of pipelle is at par with conventional D & C, so pipelle can be recommended for all perimenopausal patients with AUB. Pipelle requires less skill and requires less time as compared to D and C and therefore it can be done by any trained paramedical or junior staff in shorter duration And lastly, sterile operation theatre environment is not needed for pipelle endometrial sampling. Therefore, it can be used in combination with Pap smear for large scale screening camp procedures.