Journal of Obstetrics and Gynaecology
ISSN: 0144-3615 (Print) 1364-6893 (Online) Journal homepage: http://www.tandfonline.com/loi/ijog20
Comparison of Pipelle sampler with conventional dilatation and curettage (D&C) for Chinese endometrial biopsy H. Liu, F.-L. Wang, Y.-M. Zhao, Y.-Q. Yao & Y.-L. Li To cite this article: H. Liu, F.-L. Wang, Y.-M. Zhao, Y.-Q. Yao & Y.-L. Li (2015) Comparison of Pipelle sampler with conventional dilatation and curettage (D&C) for Chinese endometrial biopsy, Journal of Obstetrics and Gynaecology, 35:5, 508-511, DOI: 10.3109/01443615.2014.970524 To link to this article: http://dx.doi.org/10.3109/01443615.2014.970524
Published online: 14 Oct 2015.
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Date: 27 October 2015, At: 13:37
Journal of Obstetrics and Gynaecology, July 2015; 35: 508–511 © 2015 Taylor & Francis Group, LLC ISSN 0144-3615 print/ISSN 1364-6893 online DOI: 10.3109/01443615.2014.970524
GYNAECOLOGY
Comparison of Pipelle sampler with conventional dilatation and curettage (D&C) for Chinese endometrial biopsy H. Liu1, F.-L. Wang2, Y.-M. Zhao1, Y.-Q. Yao1 & Y.-L. Li1 1Department of Obstetrics and Gynecology, Chinese PLA General Hospital, Beijing, P. R. China and 2Department of Pathology, Chinese PLA
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General Hospital, Beijing, P. R. China
The aim of this study is to investigate the accuracy and adequacy of the Pipelle endometrial sampler for endometrial biopsy as compared with those of conventional dilatation and curettage (D&C). A total of 245 patients subject to endometrial biopsy were included in this study. We have shown that the failure rates with D&C and Pipelle were 7.75% and 8.98%, respectively, without statistical difference. Additionally, the obtained specimen quality and accurate diagnosis of various diseases using the two methods had no significant statistical differences. Furthermore, patients experienced less pain when Pipelle sampler was used than D&C. Therefore, Pipelle sampler is effective in obtaining adequate endometrial tissue for histodiagnosis, and is applicable in most of the cases for Chinese endometrial biopsy. Keywords: Diagnostic curettage, endometrium, pipelle endometrial sampler, pathological diagnosis
usable and histologically accurate method (Demirkiran et al. 2012). Pipelle can provide adequate samples for histological and reliable results, which reduces the rate of false-negative results for endometrial cancer and is particularly useful in post-menopausal women and in women with endometrial atrophy (Polena et al. 2007). A previous study (Fakhar et al. 2008) also confirmed the Pipelle has a sensitivity, specificity, and positive predictive and negative predictive values of 100% for endometrial carcinoma, hyperplasia and secretory endometrium. However, there are few reports about endometrial biopsy using Pipelle sampler in China (Ries et al. 2000). It remains unclear whether Pipelle endometrial sampler is suitable for Chinese who need diagnostic curettage, and the accuracy for histological diagnosis requires further investigation.
Materials and methods Introduction Endometrial biopsy is an important diagnostic method of gynecological diseases (Demirkiran et al. 2012). Conventional diagnostic curettage (dilatation and curettage [D&C]) is known as the most important method for the diagnosis of endometrial pathology (McMenamin et al. 2012). Previously, this sampling procedure was widely considered to be the method for obtaining samples of endometrium for histopathological evaluation (Djurdjevic et al. 2009). However, it uses a sharp curette to obtain endometrium, which makes patients to suffer from obvious pain and subjects them to risk of injuring basal endometrium and perforating uterus (Abulafia et al. 2011). Moreover, the cost and administration of general anaesthesia have made it less favourable, and many studies have reported its diagnostic accuracy and cost-related issues (Dijkhuizen et al. 2000; Guler et al. 2010). Pipelle endometrial sampler, an endometrial biopsy instrument which aims at reducing the biopsy procedure in patients with endometrial damage and alleviating the sufferance from the surgical procedure, has become the conventional instruments for endometrial biopsy (Williams et al. 2008). This outpatient procedure has gradually replaced the D&C in many diagnostic scenarios because of its low cost, convenience and patient acceptance (Fakhar et al., 2008; Kazandi et al. 2012). Multiple studies have compared Pipelle with D&C to diagnose endometrial carcinoma in patients with post-menopausal bleeding, which revealed Pipelle endometrial biopsy to be an easily
Research subjects Patients with indications of diagnostic curettage, who visited department of obstetrics and gynecology clinic in Chinese PLA General Hospital from August to November 2011, were included in this study. The study protocol was approved by the hospital ethics committee. The pre-operative examination was conducted, informed consent was signed and then the patients underwent pre-operative outpatient surgery in the awake state.
Surgical instruments and surgical procedures Pipelle endometrial sampler (Pipelle de Cornier, Laboratoire C.C.D, France) was introduced without performing cervical dilatation and withdrawn outside the uterus in a rotatory movement to obtain the sample. The patients were then transferred to the operative theatre for D&C. The two operations were conducted by the same obstetrician and the patients’ discomfort was recorded in two sampling processes; then the obtained endometrium was fixed for inspection. Both samples were sent to a pathologist, who was blinded to the methods of sampling and patients’ medical history for histopathology assessment.
Quality assessment of pathological diagnosis and pathological specimens Endometrial specimens were fixed, embedded, sliced and stained by the same pathologist who performed the pathological diagnosis and assessed the specimen quality. Then histological diagnosis consistency and satisfaction of pathological specimen with the
Correspondence: Ya-li Li, Department of Obstetrics and Gynecology, Chinese PLA General Hospital, No. 28, Fuxing road, Beijing 100853, P. R. China. Tel./Fax: ⫹ 86-010-66938344. E-mail: [email protected].
Pipelle sampler for Chinese endometrial biopsy 509 Table I. Effects of both sampling methods and comparison of pathological outcome. Pipelle sampler Normal Benign endometrium proliferation
D&C
Downloaded by [Universite Laval] at 13:37 27 October 2015
Normal endometriuma Benign proliferationb Atypical hyperplasia Endometrial cancer Benign polyps Endometritis Atrophic endometrium Broken endometrium Sampling failure Total aNormal bBenign
Atypical hyperplasia
Endometrial Benign cancer polyps Endometritis
Atrophic Broken Sampling endometrium endometrium failure
Total
94
0
0
0
1
2
0
1
1
99
1
70
0
0
1
0
0
0
0
72
0
1
8
0
0
0
0
0
0
9
0
0
0
8
0
0
0
0
0
8
1 1 0
1 0 0
0 0 0
0 0 0
6 0 0
1 11 1
0 0 5
0 0 2
0 1 2
9 13 10
0
0
0
0
0
0
0
3
3
6
2 99
0 72
0 8
0 8
0 8
1 16
0 5
1 7
15 22
19 245
endometrium: endometrial proliferative phase, secretory phase and menstrual period. hyperplasia: simple hyperplasia and complex hyperplasia.
two methods were evaluated. Of the diagnostic specimens with inconsistencies, high-grade histological diagnosis was used as the final pathological result.
Statistical analysis SPSS 15.0 software was used to test results and P ⬍ 0.05 was considered statistically significant.
Results
consistency with the two biopsy methods was 100%. Both D&C and Pipelle methods could not detect one case of simple hyperplasia. D&C identified all the nine cases of atypical hyperplasia, but one case was undiagnosed using Pipelle, who was 40 years old with irregular vaginal bleeding curettage. In the 11 cases of endometrial polyps, 2 cases were undiagnosed using D&C, whereas 3 cases could not be detected using Pipelle. There were no significant statistical differences in terms of the accurate diagnosis of various diseases using the two biopsy methods (p ⬎ 0.05).
Diagnosis results with Pipelle sampler and D&C
Patient discomfort level of the sampling process
A total of 245 patients with an average age of 43.6 years were diagnosed with Pipelle sampler and D&C. Of the cases, 202 cases were in the pre-menopausal period, while 43 were the post-menopausal period. The pathological results obtained by Pipelle sampler and D&C are shown in Table I. Among the 245 patients, 9 cases were diagnosed with atypical hyperplasia and 8 cases were diagnosed with endometrial cancer. Meanwhile, 213 cases were identified to have benign disease or normal endometrium. It was observed that 15 cases were reported to have insufficient material with the two methods.
The level of discomfort in the process of obtaining endometrium sample was reported by the patients as no pain, mild pain and obvious pain. Only 8.6% of the patients (21 cases) reported mild pain when Pipelle sampler was used. In terms of D&C, 24.5% of the patients (60 cases) felt mild pain, while 66.1% of the patients (162 cases) felt obvious pain, of which 4 patients needed appropriate dilatation of the cervix opening under anaesthesia. The difference was statistically significant (χ2 test, p ⬍ 0.001).
Sampling success rate and satisfaction of specimens
Diagnostic curettage has been considered to be one of the standard criterion in diagnostic evaluation of gynaecology (Kurosawa et al. 2012). However, trauma and complications can occur during curettage procedure, causing haemorrhage, uterine perforation, post-procedural infection, etc. (Ozaki and Suzuki 2013; Soeda et al. 2012). The Pipelle used in this study caused mild discomfort in only 8.6% of the patients, making it easy for the patients to
Among the 245 patients, 19 cases were undiagnosed using D&C sampler and 22 cases could not be detected using Pipelle method—the failure rate was 7.76% and 8.98%, respectively, with no statistically significant difference. Two nineteen specimens can be used for comparing the satisfaction of the specimens quality, which were rated satisfactory, general and poor; the results with D&C were calculated to be 74%, 23.3% and 2.7%, respectively (Table II). It was seen that the satisfaction of quality of the specimens obtained using Pipelle sampler was consistent with that using D&C (χ2 ⫽ 0.9660, P ⬍ 0.01).
Discussion
Table II. The satisfaction of specimens with different instruments for sampling. Sampler
The pathological diagnosis consistency with different sampling methods
D&C
We classified the diseases with abnormal pathological results and calculated the consistency of the final diagnosis with the two biopsy methods. The results are shown in Table III. In terms of benign hyperplasia and endometrial cancer, the diagnostic
Satisfaction General Poor total
Satisfaction
General
Poor
Total
160 0 0 160
2 50 0 52
0 1 6 7
162 51 6 219
510
H. Liu et al.
Table III. The diagnostic consistency of the different diseases with the two sampling methods. Diseases
Downloaded by [Universite Laval] at 13:37 27 October 2015
Benign hyperplasia Atypical hyperplasia Endometrial cancer Benign polyps Endometritis
D&C
Pipelle
p
98.6 (72/73) 100 (9/9) 100 (8/8) 81.8 (9/11) 84.6 (13/18)
98.6 (72/73) 88.9 (8/9) 100 (8/8) 72.7 (8/11) 92.3 (16/18)
⬎ 0.05 ⬎ 0.05 ⬎ 0.05 ⬎ 0.05 ⬎ 0.05
receive this method than D&C, in line with modern minimally invasive medical concepts. It has been reported that D&C has the problem of inadequate sampling and missed cases. Researchers compared the diagnostic curettage and subsequent hysterectomy specimens, and found that less than half of the uterine tissue was obtained in 60% of patients who underwent curettage and less than a quarter of the uterine tissue was obtained in 16% of patients only, with the added risk of general anaesthesia, infection and perforation (Abdelazim et al., 2013; Dongol et al. 2010). Our results confirmed that methods using both Pipelle sampler and D&C have the possibility of undiagnosed cases, especially in the diagnosis of endometrial polyps. The missed cases may be due to the limited capacity of sampler cavity. Moreover, the amount of obtained endometrial tissue can be affected by uterine haemorrhage, resulting in failure of obtaining the typical lesions. In the past 20 years, it has been reported that endometrial sampling diagnosis of endometrial cancer is very reliable. Huang GS (O’Hanlan et al. 2005) conducted a retrospective analysis of 360 uterine endometrial cancer cases and found that Pipelle sampling had a diagnostic sensitivity of 93.8% in detecting lowgrade endometrial cancer, while the D&C was 97%. In high-grade endometrial carcinoma (grade-3 endometrioid carcinoma, serous carcinoma, clear-cell carcinoma and carcinosarcoma), the sensitivity was 99.2% using Pipelle and 100% using D&C. Thus, the pathological diagnosis and grading had a high consistency compared with that of post-operative diagnosis. In the present study, there were 22 undiagnosed cases using the Pipelle and 19 cases using the D&C. The patients with failed sampling were mainly post-menopausal women, which was consistent with the previously reported results (Williams et al. 2008; Karadadas et al. 2003). The adequacy and comprehensive sampling of the two methods correlated with endometrial thickness, toughness, lesion characteristics and even uterine morphology. Researchers have reported that the thickness of post-menopausal endometrium of ⬍ 4mm, endometrial polyps, submucosal fibroids and endometritis are common factors that lead to sampling failure. In the present study, we also found many sampling failure cases in post-menopausal patients with endometrial thickness of ⬎ 5mm, in which 2 cases of uterine endometrial polyps were confirmed. Both conventional curettage and Pipelle sampler had limited success rate in nearly 80% of post-menopausal patients with post-menopausal bleeding and endometrial thickening; therefore, the patients with sampling failure should be strictly followed up or undergo diagnostic hysteroscopy (Dacco et al. 2012; Ngu et al. 2012). The limitation of our study is the lack of direct biopsy methods, such as hysteroscopy. In a study comparing hysteroscopy with Pipelle method, the sensitivity of hysteroscopy was found to be 94.4% and Pipelle was found to be 97.5% for detection of endometrial carcinoma (Saadia et al. 2011). It has been described that an appropriate way to evaluate the adequacy of Pipelle in the identification of endometrial pathologies is to compare the findings with hysterectomy results (Kazandi et al. 2012). However, a significant number of hysteroscopy procedures are still performed
under general anaesthesia. Researchers also found that a worse diagnostic rate would be expected after hysteroscopy when the uterine cavity has been distended with liquid, and in this case the biopsy device would be expected to withdraw liquid as well as endometrial tissue (Madari et al. 2009). In summary, the results of this study suggested that there is no significant difference in rate of obtaining an adequate sample between the two methods; most endometrial pathology diagnosed by D&C alone was also picked up by Pipelle. Therefore, in the context of a health care setting where hysteroscopy is not available, Pipelle can provide an alternative method with more convenience and lower cost for endometrial sampling, which is more acceptable to patients than conventional D&C.
Acknowledgement This work was supported by the PLA medical and health research funded projects of China, No. 06G101.
Declaration of interest: The authors report no declarations of interest. The authors alone are responsible for the content and writing of the paper.
References Abdelazim, IA, Aboelezz A, Abdulkareem AF. 2013. Pipelle endometrial sampling versus conventional dilatation & curettage in patients with abnormal uterine bleeding. Journal of the Turkish German Gynecology Association 14:1–5. Abulafia O, Shah T, Salame G, Economos K, Serur E, Zinn H et al. 2011. Sonographic and magnetic resonance imaging findings of pelvic abscess following uterine perforation sustained during office endometrial sampling. Journal of Medical Ultrasound 39:283–286. Dacco MD, Moustafa M, Papoutsis D, Georgantzis D, Halmos G, Magos A. 2012. An audit of using the H Pipelle for endometrial sampling at outpatient hysteroscopy and literature review comparison with the Pipelle de Cornier. European Journal of Obstetrics and Gynecology and Reproductive Biology 165: 299–301. Demirkiran F, Yavuz E, Erenel H, Bese T, Arvas M, Sanioglu C. 2012. Which is the best technique for endometrial sampling? Aspiration (pipelle) versus dilatation and curettage (D & C). Archives of Gynecology and Obstetrics 286:1277–1282. Dijkhuizen FP, Mol BW, Brölmann HA, Heintz AP. 2000. The accuracy of endometrial sampling in the diagnosis of patients with endometrial carcinoma and hyperplasia: A meta-analysis. Cancer 89:1765–1772. Djurdjevic S, Stojanovic S, Kopitovic V, Hadnadjev D. 2009. Diagnostic value of endosonography scoring systems in the detection of ovarian and endometrial carcinoma. Journal of Balkan Union of Oncology 14:97–102. Dongol A, Shrestha A, Chawla C. 2010. Post partum haemorrhage: Prevalence, morbidity and management pattern in Dhulikhel Hospital. Kathmandu University Medical Journal 8:212–215. Fakhar S, Saeed G, Khan AH, Alam AY. 2008. Validity of pipelle endometrial sampling in patients with abnormal uterine bleeding. Annals of Saudi Medicine 28:188–191. Guler A, Sahin HG, Kucukaydin Z, Erdemoglu E. 2010. Comparison of the efficacy of intrauterine lidocaine, paracervical block and oral etodolac for decreasing pain in endometrial biopsy. Journal of the Turkish German Gynecology Association 11:178–181. Karadadas N, Sirkeci F, Akercan F, Ulukus M, Kazandi M. 2003. Retrospective analysis of endometrial polyps carried out at Ege University Hospital. Clinical and Experimental Obstetrics and Gynecology 31:137–138. Kazandi M, Okmen F, Ergenoglu AM, Yeniel AO, Zeybek B, Zekioglu O, Ozdemir N. 2012. Comparison of the success of histopathological diagnosis with dilatation-curettage and Pipelle endometrial sampling. Journal of Obstetrics and Gynaecology 32:790–794. Kurosawa H, Ito K, Nikura H, Takano T, Nagase S, Utsunomiya H et al. 2012. Hysteroscopic inspection and total curettage are insufficient for discriminating endometrial cancer from atypical endometrial hyperplasia. Tohoku Journal of Experimental Medicine 228:365–370. Madari S, Al‐Shabibi N, Papalampros P, Papadimitriou A, Magos A. 2009. A randomised trial comparing the H Pipelle with the standard Pipelle for endometrial sampling at ‘no‐touch’(vaginoscopic) hysteroscopy. Brit-
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ish Journal of Obstetrics and Gynaecology: An International Journal of Obstetrics and Gynaecology 116:32–37. McMenamin M, Lysakova-Devine T, Wingfield M, O’Herlihy C, O’Farrelly C. 2012. Endometrial aspiration biopsy: a non-invasive method of obtaining functional lymphoid progenitor cells and mature natural killer cells. Reproductive BioMedicine Online 25:322–328. Ngu SF, Cheung VY, Pun TC. 2012. Randomized study of vaginoscopy and H Pipelle vs traditional hysteroscopy and standard Pipelle. Journal of Minimally Invasive Gynecology 19:206–211. O’Hanlan KA, Huang GS, Garnier AC, Dibble SL, Reuland ML, Lopez L, Pinto RL. 2005. Total laparoscopic hysterectomy versus total abdominal hysterectomy: cohort review of patients with uterine neoplasia. Journal of the Society of Laparoendoscopic Surgeons 9:277–286. Ozaki K, Suzuki S. 2013. Uterine perforation with omentum incarceration after dilatation and evacuation/curettage. Archives of Gynecology and Obstetrics 1–2.
Polena V, Mergui JL, Zerat L, Sananes S. 2007. The role of Pipelle Mark II sampling in endometrial disease diagnosis. European Journal of Obstetrics and Gynecology and Reproductive Biology 134:233–237. Ries A, Singson P, Bidus M, Barnes JG. 2000. Use of the endometrial pipelle in the diagnosis of early abnormal gestations. Fertility and Sterility 74:593–595. Saadia A, Mubarik A, Zubair A, Jamal S, Zafar A. 2011. Diagnostic accuracy of endometrial curettage in endometrial pathology. Journal of Ayub Medical College, Abbottabad 23:129–131. Soeda S, Ushijima J, Furukawa S, Miyajima M, Sakuma K, Watanabe T et al. 2012. Uterine arteriovenous malformation formed in a large uterine cervical myoma. Tohoku Journal of Experimental Medicine 228:181–187. Williams A, Brechin S, Porter A, Warner P, Critchley H. 2008. Factors affecting adequacy of Pipelle and Tao Brush endometrial sampling. British Journal of Obstetrics and Gynaecology: An International Journal of Obstetrics and Gynaecology 115:1028–1036.
ISSN: 0144-3615 (Print) 1364-6893 (Online) Journal homepage: http://www.tandfonline.com/loi/ijog20
Comparison of Pipelle sampler with conventional dilatation and curettage (D&C) for Chinese endometrial biopsy H. Liu, F.-L. Wang, Y.-M. Zhao, Y.-Q. Yao & Y.-L. Li To cite this article: H. Liu, F.-L. Wang, Y.-M. Zhao, Y.-Q. Yao & Y.-L. Li (2015) Comparison of Pipelle sampler with conventional dilatation and curettage (D&C) for Chinese endometrial biopsy, Journal of Obstetrics and Gynaecology, 35:5, 508-511, DOI: 10.3109/01443615.2014.970524 To link to this article: http://dx.doi.org/10.3109/01443615.2014.970524
Published online: 14 Oct 2015.
Submit your article to this journal
Article views: 3
View related articles
View Crossmark data
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ijog20 Download by: [Universite Laval]
Date: 27 October 2015, At: 13:37
Journal of Obstetrics and Gynaecology, July 2015; 35: 508–511 © 2015 Taylor & Francis Group, LLC ISSN 0144-3615 print/ISSN 1364-6893 online DOI: 10.3109/01443615.2014.970524
GYNAECOLOGY
Comparison of Pipelle sampler with conventional dilatation and curettage (D&C) for Chinese endometrial biopsy H. Liu1, F.-L. Wang2, Y.-M. Zhao1, Y.-Q. Yao1 & Y.-L. Li1 1Department of Obstetrics and Gynecology, Chinese PLA General Hospital, Beijing, P. R. China and 2Department of Pathology, Chinese PLA
Downloaded by [Universite Laval] at 13:37 27 October 2015
General Hospital, Beijing, P. R. China
The aim of this study is to investigate the accuracy and adequacy of the Pipelle endometrial sampler for endometrial biopsy as compared with those of conventional dilatation and curettage (D&C). A total of 245 patients subject to endometrial biopsy were included in this study. We have shown that the failure rates with D&C and Pipelle were 7.75% and 8.98%, respectively, without statistical difference. Additionally, the obtained specimen quality and accurate diagnosis of various diseases using the two methods had no significant statistical differences. Furthermore, patients experienced less pain when Pipelle sampler was used than D&C. Therefore, Pipelle sampler is effective in obtaining adequate endometrial tissue for histodiagnosis, and is applicable in most of the cases for Chinese endometrial biopsy. Keywords: Diagnostic curettage, endometrium, pipelle endometrial sampler, pathological diagnosis
usable and histologically accurate method (Demirkiran et al. 2012). Pipelle can provide adequate samples for histological and reliable results, which reduces the rate of false-negative results for endometrial cancer and is particularly useful in post-menopausal women and in women with endometrial atrophy (Polena et al. 2007). A previous study (Fakhar et al. 2008) also confirmed the Pipelle has a sensitivity, specificity, and positive predictive and negative predictive values of 100% for endometrial carcinoma, hyperplasia and secretory endometrium. However, there are few reports about endometrial biopsy using Pipelle sampler in China (Ries et al. 2000). It remains unclear whether Pipelle endometrial sampler is suitable for Chinese who need diagnostic curettage, and the accuracy for histological diagnosis requires further investigation.
Materials and methods Introduction Endometrial biopsy is an important diagnostic method of gynecological diseases (Demirkiran et al. 2012). Conventional diagnostic curettage (dilatation and curettage [D&C]) is known as the most important method for the diagnosis of endometrial pathology (McMenamin et al. 2012). Previously, this sampling procedure was widely considered to be the method for obtaining samples of endometrium for histopathological evaluation (Djurdjevic et al. 2009). However, it uses a sharp curette to obtain endometrium, which makes patients to suffer from obvious pain and subjects them to risk of injuring basal endometrium and perforating uterus (Abulafia et al. 2011). Moreover, the cost and administration of general anaesthesia have made it less favourable, and many studies have reported its diagnostic accuracy and cost-related issues (Dijkhuizen et al. 2000; Guler et al. 2010). Pipelle endometrial sampler, an endometrial biopsy instrument which aims at reducing the biopsy procedure in patients with endometrial damage and alleviating the sufferance from the surgical procedure, has become the conventional instruments for endometrial biopsy (Williams et al. 2008). This outpatient procedure has gradually replaced the D&C in many diagnostic scenarios because of its low cost, convenience and patient acceptance (Fakhar et al., 2008; Kazandi et al. 2012). Multiple studies have compared Pipelle with D&C to diagnose endometrial carcinoma in patients with post-menopausal bleeding, which revealed Pipelle endometrial biopsy to be an easily
Research subjects Patients with indications of diagnostic curettage, who visited department of obstetrics and gynecology clinic in Chinese PLA General Hospital from August to November 2011, were included in this study. The study protocol was approved by the hospital ethics committee. The pre-operative examination was conducted, informed consent was signed and then the patients underwent pre-operative outpatient surgery in the awake state.
Surgical instruments and surgical procedures Pipelle endometrial sampler (Pipelle de Cornier, Laboratoire C.C.D, France) was introduced without performing cervical dilatation and withdrawn outside the uterus in a rotatory movement to obtain the sample. The patients were then transferred to the operative theatre for D&C. The two operations were conducted by the same obstetrician and the patients’ discomfort was recorded in two sampling processes; then the obtained endometrium was fixed for inspection. Both samples were sent to a pathologist, who was blinded to the methods of sampling and patients’ medical history for histopathology assessment.
Quality assessment of pathological diagnosis and pathological specimens Endometrial specimens were fixed, embedded, sliced and stained by the same pathologist who performed the pathological diagnosis and assessed the specimen quality. Then histological diagnosis consistency and satisfaction of pathological specimen with the
Correspondence: Ya-li Li, Department of Obstetrics and Gynecology, Chinese PLA General Hospital, No. 28, Fuxing road, Beijing 100853, P. R. China. Tel./Fax: ⫹ 86-010-66938344. E-mail: [email protected].
Pipelle sampler for Chinese endometrial biopsy 509 Table I. Effects of both sampling methods and comparison of pathological outcome. Pipelle sampler Normal Benign endometrium proliferation
D&C
Downloaded by [Universite Laval] at 13:37 27 October 2015
Normal endometriuma Benign proliferationb Atypical hyperplasia Endometrial cancer Benign polyps Endometritis Atrophic endometrium Broken endometrium Sampling failure Total aNormal bBenign
Atypical hyperplasia
Endometrial Benign cancer polyps Endometritis
Atrophic Broken Sampling endometrium endometrium failure
Total
94
0
0
0
1
2
0
1
1
99
1
70
0
0
1
0
0
0
0
72
0
1
8
0
0
0
0
0
0
9
0
0
0
8
0
0
0
0
0
8
1 1 0
1 0 0
0 0 0
0 0 0
6 0 0
1 11 1
0 0 5
0 0 2
0 1 2
9 13 10
0
0
0
0
0
0
0
3
3
6
2 99
0 72
0 8
0 8
0 8
1 16
0 5
1 7
15 22
19 245
endometrium: endometrial proliferative phase, secretory phase and menstrual period. hyperplasia: simple hyperplasia and complex hyperplasia.
two methods were evaluated. Of the diagnostic specimens with inconsistencies, high-grade histological diagnosis was used as the final pathological result.
Statistical analysis SPSS 15.0 software was used to test results and P ⬍ 0.05 was considered statistically significant.
Results
consistency with the two biopsy methods was 100%. Both D&C and Pipelle methods could not detect one case of simple hyperplasia. D&C identified all the nine cases of atypical hyperplasia, but one case was undiagnosed using Pipelle, who was 40 years old with irregular vaginal bleeding curettage. In the 11 cases of endometrial polyps, 2 cases were undiagnosed using D&C, whereas 3 cases could not be detected using Pipelle. There were no significant statistical differences in terms of the accurate diagnosis of various diseases using the two biopsy methods (p ⬎ 0.05).
Diagnosis results with Pipelle sampler and D&C
Patient discomfort level of the sampling process
A total of 245 patients with an average age of 43.6 years were diagnosed with Pipelle sampler and D&C. Of the cases, 202 cases were in the pre-menopausal period, while 43 were the post-menopausal period. The pathological results obtained by Pipelle sampler and D&C are shown in Table I. Among the 245 patients, 9 cases were diagnosed with atypical hyperplasia and 8 cases were diagnosed with endometrial cancer. Meanwhile, 213 cases were identified to have benign disease or normal endometrium. It was observed that 15 cases were reported to have insufficient material with the two methods.
The level of discomfort in the process of obtaining endometrium sample was reported by the patients as no pain, mild pain and obvious pain. Only 8.6% of the patients (21 cases) reported mild pain when Pipelle sampler was used. In terms of D&C, 24.5% of the patients (60 cases) felt mild pain, while 66.1% of the patients (162 cases) felt obvious pain, of which 4 patients needed appropriate dilatation of the cervix opening under anaesthesia. The difference was statistically significant (χ2 test, p ⬍ 0.001).
Sampling success rate and satisfaction of specimens
Diagnostic curettage has been considered to be one of the standard criterion in diagnostic evaluation of gynaecology (Kurosawa et al. 2012). However, trauma and complications can occur during curettage procedure, causing haemorrhage, uterine perforation, post-procedural infection, etc. (Ozaki and Suzuki 2013; Soeda et al. 2012). The Pipelle used in this study caused mild discomfort in only 8.6% of the patients, making it easy for the patients to
Among the 245 patients, 19 cases were undiagnosed using D&C sampler and 22 cases could not be detected using Pipelle method—the failure rate was 7.76% and 8.98%, respectively, with no statistically significant difference. Two nineteen specimens can be used for comparing the satisfaction of the specimens quality, which were rated satisfactory, general and poor; the results with D&C were calculated to be 74%, 23.3% and 2.7%, respectively (Table II). It was seen that the satisfaction of quality of the specimens obtained using Pipelle sampler was consistent with that using D&C (χ2 ⫽ 0.9660, P ⬍ 0.01).
Discussion
Table II. The satisfaction of specimens with different instruments for sampling. Sampler
The pathological diagnosis consistency with different sampling methods
D&C
We classified the diseases with abnormal pathological results and calculated the consistency of the final diagnosis with the two biopsy methods. The results are shown in Table III. In terms of benign hyperplasia and endometrial cancer, the diagnostic
Satisfaction General Poor total
Satisfaction
General
Poor
Total
160 0 0 160
2 50 0 52
0 1 6 7
162 51 6 219
510
H. Liu et al.
Table III. The diagnostic consistency of the different diseases with the two sampling methods. Diseases
Downloaded by [Universite Laval] at 13:37 27 October 2015
Benign hyperplasia Atypical hyperplasia Endometrial cancer Benign polyps Endometritis
D&C
Pipelle
p
98.6 (72/73) 100 (9/9) 100 (8/8) 81.8 (9/11) 84.6 (13/18)
98.6 (72/73) 88.9 (8/9) 100 (8/8) 72.7 (8/11) 92.3 (16/18)
⬎ 0.05 ⬎ 0.05 ⬎ 0.05 ⬎ 0.05 ⬎ 0.05
receive this method than D&C, in line with modern minimally invasive medical concepts. It has been reported that D&C has the problem of inadequate sampling and missed cases. Researchers compared the diagnostic curettage and subsequent hysterectomy specimens, and found that less than half of the uterine tissue was obtained in 60% of patients who underwent curettage and less than a quarter of the uterine tissue was obtained in 16% of patients only, with the added risk of general anaesthesia, infection and perforation (Abdelazim et al., 2013; Dongol et al. 2010). Our results confirmed that methods using both Pipelle sampler and D&C have the possibility of undiagnosed cases, especially in the diagnosis of endometrial polyps. The missed cases may be due to the limited capacity of sampler cavity. Moreover, the amount of obtained endometrial tissue can be affected by uterine haemorrhage, resulting in failure of obtaining the typical lesions. In the past 20 years, it has been reported that endometrial sampling diagnosis of endometrial cancer is very reliable. Huang GS (O’Hanlan et al. 2005) conducted a retrospective analysis of 360 uterine endometrial cancer cases and found that Pipelle sampling had a diagnostic sensitivity of 93.8% in detecting lowgrade endometrial cancer, while the D&C was 97%. In high-grade endometrial carcinoma (grade-3 endometrioid carcinoma, serous carcinoma, clear-cell carcinoma and carcinosarcoma), the sensitivity was 99.2% using Pipelle and 100% using D&C. Thus, the pathological diagnosis and grading had a high consistency compared with that of post-operative diagnosis. In the present study, there were 22 undiagnosed cases using the Pipelle and 19 cases using the D&C. The patients with failed sampling were mainly post-menopausal women, which was consistent with the previously reported results (Williams et al. 2008; Karadadas et al. 2003). The adequacy and comprehensive sampling of the two methods correlated with endometrial thickness, toughness, lesion characteristics and even uterine morphology. Researchers have reported that the thickness of post-menopausal endometrium of ⬍ 4mm, endometrial polyps, submucosal fibroids and endometritis are common factors that lead to sampling failure. In the present study, we also found many sampling failure cases in post-menopausal patients with endometrial thickness of ⬎ 5mm, in which 2 cases of uterine endometrial polyps were confirmed. Both conventional curettage and Pipelle sampler had limited success rate in nearly 80% of post-menopausal patients with post-menopausal bleeding and endometrial thickening; therefore, the patients with sampling failure should be strictly followed up or undergo diagnostic hysteroscopy (Dacco et al. 2012; Ngu et al. 2012). The limitation of our study is the lack of direct biopsy methods, such as hysteroscopy. In a study comparing hysteroscopy with Pipelle method, the sensitivity of hysteroscopy was found to be 94.4% and Pipelle was found to be 97.5% for detection of endometrial carcinoma (Saadia et al. 2011). It has been described that an appropriate way to evaluate the adequacy of Pipelle in the identification of endometrial pathologies is to compare the findings with hysterectomy results (Kazandi et al. 2012). However, a significant number of hysteroscopy procedures are still performed
under general anaesthesia. Researchers also found that a worse diagnostic rate would be expected after hysteroscopy when the uterine cavity has been distended with liquid, and in this case the biopsy device would be expected to withdraw liquid as well as endometrial tissue (Madari et al. 2009). In summary, the results of this study suggested that there is no significant difference in rate of obtaining an adequate sample between the two methods; most endometrial pathology diagnosed by D&C alone was also picked up by Pipelle. Therefore, in the context of a health care setting where hysteroscopy is not available, Pipelle can provide an alternative method with more convenience and lower cost for endometrial sampling, which is more acceptable to patients than conventional D&C.
Acknowledgement This work was supported by the PLA medical and health research funded projects of China, No. 06G101.
Declaration of interest: The authors report no declarations of interest. The authors alone are responsible for the content and writing of the paper.
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