|Year : 2021 | Volume
| Issue : 2 | Page : 87-92
A comparison of endometrial sampling histopathology by Pipelle curette versus Karman cannula in patients with abnormal uterine bleeding at a tertiary care hospital in Northwest Rajasthan
Kirti Solanki, Swati Kochar, Laxmi Poonia, Priyanka Gaur, Krishna Poonia, Shweta Choudhary
Department of Obstetrics and Gynaecology, Sardar Patel Medical College, Bikaner, Jaipur, Rajasthan, India
|Date of Submission||03-Apr-2021|
|Date of Decision||29-May-2021|
|Date of Acceptance||28-Jun-2021|
|Date of Web Publication||30-Dec-2021|
PBM Hospital, Bikaner - 334 001, Jaipur, Rajasthan
Source of Support: None, Conflict of Interest: None
Background: Abnormal uterine bleeding (AUB) is a common and devastating condition affecting women of all ages. Among all patients attending gynecology outpatient department clinic, more than one-third patients are related to AUB, and this proportion rises to 70% in the perimenopausal and postmenopausal age. The condition has a high reported prevalence rate of 17.9% in India.
Aims and Objective: To compare endometrial sampling histopathology by Pipelle curette versus Karman cannula in patients with AUB at a tertiary care hospital in Northwest Rajasthan.
Materials and Methods: It was a prospective study conducted on 100 female patients of all age groups attending the department of obstetrics and gynecology over a period of 1 year with clinical diagnosis of AUB. After detailed history, examination, and relevant investigations, each patient was subjected first to endometrial aspiration using Pipelle curette followed by endometrial aspiration using Karman cannula No. 4. Samples collected were sent for histopathological assessment and the results were compared.
Results: In our study, in 84% of cases, samples obtained by both Pipelle curette and Karman cannula were adequate. In 5% of cases, samples were inadequate by both methods. In 10% of cases, Karman cannula sample was adequate, but Pipelle curette sample was inadequate. In 1% of cases, sample could not be obtained by both procedures due to stenosed nulliparous cervix with large fibroid obstructing cervical os. Considering Karman cannula as the standard, Pipelle curette endometrial sampling demonstrated 100% sensitivity, specificity, positive and negative predictive value (PPV and NPV), and accuracy with regard to diagnosis of adenocarcinoma and endometrial hyperplasia. For secretory endometrium, the corresponding values were 76.5%, 100%, 100%, 95.4%, and 99%, respectively. With regard to proliferative endometrium, sensitivity, specificity, PPV, NPV, and accuracy were 92%, 96%, 98.6%, 80%, and 93%, respectively. With regard to atrophic endometrium, specificity, NPV, and accuracy were 100%, 99%, and 99%, respectively. Pipelle curette had a concordance rate of 87.5% with hysterectomy specimen, while Karman cannula had a concordance rate of 100%.
Conclusion: Both Pipelle curette and Karman cannula endometrial aspiration biopsy are easy to perform, efficient, and safe outpatient endometrial sampling procedure in recognizing the endometrial lesions including malignancy and endometrial hyperplasia; however, Karman cannula had more adequate sample than Pipelle curette.
Keywords: Abnormal uterine bleeding, Karman cannula, Pipelle curette
|How to cite this article:|
Solanki K, Kochar S, Poonia L, Gaur P, Poonia K, Choudhary S. A comparison of endometrial sampling histopathology by Pipelle curette versus Karman cannula in patients with abnormal uterine bleeding at a tertiary care hospital in Northwest Rajasthan. J Curr Res Sci Med 2021;7:87-92
|How to cite this URL:|
Solanki K, Kochar S, Poonia L, Gaur P, Poonia K, Choudhary S. A comparison of endometrial sampling histopathology by Pipelle curette versus Karman cannula in patients with abnormal uterine bleeding at a tertiary care hospital in Northwest Rajasthan. J Curr Res Sci Med [serial online] 2021 [cited 2022 Jan 19];7:87-92. Available from: https://www.jcrsmed.org/text.asp?2021/7/2/87/334450
| Introduction|| |
Abnormal uterine bleeding (AUB) is characterized by bleeding at abnormal or unexpected times or by excessive flow at the time of an expected menses. It had a vast range of presentations which include heavy cyclical bleeding, frequent menstrual cycles, frequent and heavy cyclical bleeding, irregular bleeding, and postcoital bleeding., AUB is a common and devastating condition affecting women of all ages. Among all patients attending gynecology outpatient department (OPD) clinic, more than one-third patients are related to AUB, and this proportion rises to 70% in the perimenopausal and postmenopausal age. The condition has a high reported prevalence rate of 17.9% in India.
AUB is a symptom and not a disease. It can occur in a variety of benign and malignant conditions. These causes are classified by the PALM–COEIN classification, which was suggested by the International Federation of Gynecology and Obstetrics in 2010 to standardize diagnosis and management of AUB in nonpregnant women of reproductive age group. It includes polyp (P), adenomyosis (A), leiomyoma (L), malignancy (M), coagulation disorders (C), ovulatory dysfunction (O), endometrial (E), iatrogenic (I), and not yet classified (N) causes.
Most gynecologists agree to detailed evaluation of patients with abnormal vaginal bleeding after the age of 40 years to exclude the presence of endometrial polyps, hyperplasia, fibroids, or carcinoma. Endometrial sampling is considered as the gold standard procedure for diagnosis of endometrial pathology in patients with AUB according to the PALM–COEIN classification. Earlier, dilatation and curettage (D and C) was one of the most commonly performed gynecological surgeries, used to obtain the endometrial samples, accounting for a large proportion of hospital bed use and operating room time. Its disadvantage is requirement of anesthesia for the procedure and risk of perforation and infection. Endometrial aspiration has emerged as an attractive alternative to D and C for taking endometrial sample. It is a rapid and minimally invasive modality that can be done as an OPD procedure without the requirement for anesthesia. It can be used as a safe, minimally invasive, and reliable OPD procedure with minimum discomfort to the patient.
There are many studies that had compared endometrial aspiration techniques with conventional D and C procedures, and found endometrial aspiration technique as a good alternative to conventional D and C procedures. However, there is lack of studies that could compare these newer endometrial aspiration devices. Hence, we conducted a study to compare efficacy, pain score, adequacy, and cost-effectiveness of endometrial sample obtained by Pipelle curette and Karman cannula.
| Materials and Methods|| |
It was a prospective study conducted at the Department of Obstetrics and Gynecology of Sardar Patel Medical College, Bikaner. The study was carried out on 100 female patients of all age groups attending the department of obstetrics and gynecology from October 2019 to September 2020 with a clinical diagnosis of AUB. Patients having acute inflammatory disorders of the genital tract, a viable pregnancy, and cervical carcinoma were excluded from the study. After obtaining a detailed clinical history, the patients went through a physical examination, and ultrasonography for endometrial thickness and all relevant investigations were carried out. Written consent from patients was taken after explaining the procedure.
Under all aseptic conditions, endometrial aspiration was carried out in the minor operation theater. Endometrial aspiration was first performed by Pipelle curette. Pipelle is a disposable flexible polypropylene sheath of 23.5 cm long with a soft-rounded end. Its outer diameter is 3.1 mm and inner diameter is 2.6 mm. It has an inner piston which when drawn back creates a negative pressure allowing endometrial tissue to be sucked through a perforation of 2.4 mm at the endouterine end. After introducing Pipelle into the uterine cavity, the piston was retracted to create negative pressure, and then Pipelle was withdrawn by rotatory movements. Aspirated sample was emptied in a bottle of 10% formalin, and this bottle was labeled as A. After this step in the same patient in the same sitting, endometrial aspiration was performed using plastic disposable 4 mm Karman cannula connected to a 20 cc syringe. Karman cannula no. 4 is a higher pressure device and is a flexible cannula made of latex-free polypropylene plastic. It is 24 cm in length and 4 mm in diameter. Suction is created by a 20 cc disposable syringe attached to the base of cannula. By withdrawing piston, negative pressure was created and maintained for 30 s, while the mucosa was uniformly aspirated. After releasing pressure, the cannula was removed and the surface was wiped to avoid contamination by cervical and vaginal cells. Aspirate was emptied in a bottle of 10% formalin which is labeled as B. Time was recorded for both Pipelle curette and Karman cannula from holding the cervix with vulsellum to withdrawal of device with sample. Both the samples were sent to a pathologist who was blinded for the study, for histopathological examination. The patient was asked regarding pain during the procedure and was quantified using verbal categorical rating scale (VRS). Verbal categorical scale consists of easy to interpret descriptor that range pain in four point set – none, mild, moderate, and severe. Any serious complication during the procedure was observed at least for 15 min. Ease of procedure was also compared, which was subjective interpretation and based on difficulty faced by examiner to negotiate device through cervical canal. After tissue processing, sections were obtained and stained with hematoxylin and eosin (H and E) stain. Finally, histopathological results were compared, and adequacy of samples was also compared. Adequacy of sample was defined by the pathologist on the basis of presence of intact endometrial glands and stroma on microscopic examination. In the study, procedure with Karman cannula was considered as the standard procedure. Unable to insert aspiration device through cervical os in spite of three attempts was termed as procedure failure.
Epi Info statistical software (Epi Info., USA) by the Centers for Disease Control and Prevention, USA, was used for data analysis. Quantitative data were analyzed by Student's t-test for comparison of two groups and revealed as mean and standard deviation. Qualitative data were analyzed implementing the Chi-square test and revealed as number and percentage. If one cell had expected number <5, then Fisher's exact test was applied for a 2 × 2 table. A P < 0.05 was considered statistically significant.
| Results|| |
In our study, 100 women with a clinical diagnosis of AUB were included. The demographic characteristics such as mean age, mean parity, mean endometrial thickness, mean body mass index, mean Pictorial blood loss assessment chart (PBAC) score, mean hemoglobin level, and mean platelet count of the studied cases were 47.38 ± 10.2 years, 3.02 ± 1.12, 8.99 ± 3.45 mm, 23.451 ± 1.98 kg/m2, 200.64 ± 33.19, 19.67 ± 1.61 g/dl, and 2.591 ± 0.76 lakh/mm3, respectively [Table 1].
In our study, 86% of cases were premenopausal whereas 14% of cases were postmenopausal. Among premenopausal cases, menometrorrhagia (31%) was the chief complaint followed by menorrhagia (27%), polymenorrhea (23%), and metrorrhagia (5%).
In our study, in 84% of cases, samples obtained by both Pipelle curette and Karman cannula were adequate. In 5% of cases, samples were inadequate by both methods. In 10% of cases, Karman cannula sample was adequate, but Pipelle curette sample was inadequate. In 1% of cases, there was procedure failure, that is, sample could not be obtained by both procedures due to stenosed nulliparous cervix with large fibroid obstructing cervical os. Significant difference was observed between histopathological report of Pipelle curette and Karman cannula in terms of adequacy (P = 0.003) [Table 2].
The comparison of histopathological results of Pipelle curette and Karman cannula is demonstrated in [Table 3]. After analyzing the histopathological report between Pipelle curette and Karman cannula, we found that no cases of endometrial adenocarcinoma and endometrial hyperplasia were missed by both Pipelle curette and Karman cannula endometrial sampling. There was no disparity in the reports received from both types of sampling. Out of 15 cases of inadequate sampling by Pipelle curette, 5 cases by Karman cannula sampling also had inadequate sample. Among rest 10 cases, 7 cases showed proliferative phase, 2 cases showed secretory phase, and 1 case showed atrophic endometrium on histopathological report.
Considering Karman cannula as the standard, Pipelle curette endometrial sampling demonstrated 100% sensitivity, specificity, positive and negative predictive value (PPV and NPV), and accuracy with regard to diagnosis of adenocarcinoma and endometrial hyperplasia. For secretory endometrium, the corresponding values were 76.5%, 100%, 100%, 95.4%, and 99%, respectively. With regard to proliferative endometrium, sensitivity, specificity, PPV, NPV, and accuracy were 92%, 96%, 98.6%, 80%, and 93%, respectively. With regard to atrophic endometrium, specificity, NPV, and accuracy were 100%, 99%, and 99%, respectively [Table 4].
|Table 4: Statistical analysis of endometrial patterns obtained by Pipelle's curette in comparison to Karman's cannula|
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In the study, 6.06% of procedure was termed as not easy in Karman cannula sampling when compared to Pipelle curette sampling, in which 1.01% of procedure was termed not easy, suggesting that both procedures are easy to perform (P = 0.1183).
In our study, the duration of Pipelle curette endometrial biopsy was less (2.60 ± 0.55 min) compared to Karman cannula (3.67 ± 0.63 min). Reason for less time consumption with Pipelle curette may be the presence of inbuilt negative suction pressure in Pipelle curette which needs to be created in Karman cannula.
In our study, with Pipelle curette, 16.16% of cases felt no pain during the procedure while 83.83% of cases felt mild pain. With Karman cannula, 12.12% of patients felt no pain during the procedure, while 81.81% of cases felt mild pain and 6.1% of cases felt moderate pain. None of the cases felt severe pain by any of the procedure according to VRS. No serious complication such as perforation, excessive bleeding postprocedure, and vasovagal attack occurred with both the procedures in our study.
In our study, 8 out of 100 subjects with AUB went for hysterectomy. Pipelle curette had concordance rate of 87.5% with hysterectomy specimen. In one case, Pipelle was unable to obtain adequate sample for histopathological diagnosis. Karman had concordance rate of 100% [Table 5].
|Table 5: Concordance between the results of the Pipelle curette and Karman cannula with hysterectomy specimen|
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| Discussion|| |
Endometrial sampling for histopathology is very important in the evaluation of women with AUB to find out the cause and rule out malignancy for timely intervention. Office endometrial sampling has become an important diagnostic tool in these women. These procedures do not require prolong hospital stay, general anesthesia, or operation theater facility, thereby reducing healthcare cost. In addition, these procedures are easy to perform with minimal risks involved.
In the present study, the age of the cases ranged between 20 and 74 years. Maximum number of cases were observed in the age group of >45 years. The mean age of the cases was 47.38 ± 10.2 years, which was comparable to the mean age of 46.2 ± 6.2 years in the study performed by Behnamfar et al. and 48 ± 10.08 years in the study by Kazandi et al.
In our study, 84% of samples were adequate and 15% of samples were inadequate with Pipelle curette. With Karman cannula, 94% of samples were adequate and 5% of samples were inadequate. In one case, there was procedure failure due to failure to negotiate through cervical canal by both the instrument due to the presence of large mass obstructing cervical os. Our study findings were consistent with the study conducted by Sanam and Majid (84.60% adequate sample with Pipelle curette), Navakumar et al. (86.7% adequate sample with Pipelle curette), and Nama et al. (95% adequate sample with Karman cannula). Reason for decreased adequacy by Pipelle curette in our study is maybe narrow lumen of device or lack of experience in terms of using Pipelle curette. As in later part of study, when clinicians got familiar with technique of using Pipelle curette, more adequate samples were obtained.
In our study, considering Karman endometrial sampling as the standard, Pipelle curette demonstrated 100% sensitivity, specificity, PPV, NPV, and accuracy with regard to diagnosis of adenocarcinoma and endometrial hyperplasia. Our results were comparable to the study conducted by Liu et al., and Abdelazim et al.; each study demonstrated 100% sensitivity, specificity, PPV, and NPV in diagnosing adenocarcinoma and endometrial hyperplasia by endometrial aspiration with Pipelle curette.
In the present study, Pipelle endometrial sampling reported 99% accuracy with regard to diagnosis of atrophic endometrium. However, in our study, we could detect only one case of atrophic endometrium. In atrophic endometrium, shedding of endometrium is less, so some aspirates are sometimes reported insufficient for interpretation. The results of our study were comparable to the results of Sanam and Majid, which demonstrated 98.50% of accuracy in diagnosing atrophic endometrium with endometrial aspiration using Pipelle.
In our study, Pipelle endometrial sampling reported 92%, 96%, 98.6%, 80%, and 93% of sensitivity, specificity, PPV, NPV, and accuracy with regard to diagnosis of proliferative endometrium. Our results were comparable to the study by Patankar et al., which demonstrated sensitivity, specificity, PPV, NPV, and accuracy of 91.04%, 89.65%, 91.04%, 89.65%, and 90.4%, respectively, in diagnosis of proliferative endometrium.
In our study, Pipelle endometrial sampling showed 76.50%, 100%, 100%, 95.4%, and 99% of sensitivity, specificity, PPV, NPV, and accuracy, respectively, for diagnosing secretory endometrium. Sanam and Majid reported 97.40%, 100%, 100%, 98.90% and 99.20% of sensitivity, specificity, PPV, NPV, and accuracy, respectively, in diagnosing secretory endometrium with Pipelle curette. Patnakr et al. reported sensitivity, specificity, PPV, NPV, accuracy of 76.19%, 97.11%, 84.21%, 95.28%, and 93.6%, respectively.
In our study, the concordance rate between Pipelle curette and hysterectomy was 87.5% and between Karman cannula and hysterectomy was 100%. Rezk et al. reported similar concordance rates of endometrial aspiration with Pipelle curette with regard to hysterectomy specimen as 95.1%. Nama et al. reported concordance of 95% between Karman cannula and hysterectomy, suggesting good correlation in endometrial sampling with hysterectomy specimen.
In our study, 1.01% of procedures were not easy with Pipelle curette compared to 6.06% of cases with Karman cannula. Similar findings were present in the study by Nama et al., in which 1% of procedures were not easy with Karman cannula, while in the study by Navakumar et al., 34.6% of procedures were not easy with Pipelle curette, which were high as compared to our study.
In our study, the duration of Pipelle curette endometrial sampling was less (2.60 ± 0.55 min) as compared to Karman cannula endometrial sampling (3.66 ± 0.63 min). Sanam and Majid showed that the duration of sampling with Pipelle curette was 3.38 ± 0.98 min. Zutshi et al. reported time duration with Karman cannula to be 5.4 ± 3 min.
In our study, with Pipelle curette, 16.16% of cases felt no pain, 83.83% of cases felt mild pain, and none of cases felt moderate or severe pain. With Karman cannula, 12.12% of cases felt no pain, 81.81% of cases felt mild pain, and 6.1% of cases felt moderate pain. In the study by Nama et al., during Karman endometrial sampling, 25% of the subjects felt no pain, 66% of the subjects felt mild pain, and 9% of the subjects experienced moderate pain. None of the subjects felt worst imaginable. Liu et al. reported mild pain only in 8.6% of cases of endometrial aspiration procedure with Pipelle curette.
In our study, no serious complications occurred during Pipelle curette or Karman cannula endometrial sampling procedure. Similar results were shown in the study by Nama et al. with Karman cannula and the study by Rezk et al. with Pipelle curette.
Our study was conducted at government hospital setup, so all investigations and instruments were free of cost. However, in general, the cost of Pipelle curette was Rs. 350/- and of Karman cannula with syringe was Rs. 160/-. However, other variables such as hospital stay and medicine cost are similar in both the procedures. This shows that Karman cannula is a cheaper device as compared to Pipelle curette.
However, the ease of procedure and pain assessment during Pipelle curette sampling and Karman sampling are subjective phenomenon which might have produced unintentional observer's bias in our study. It was reported as the limitation of our study.
Despite the limitations, the power of our study was that it was prospective study and performed in a single institute where the samples are analyzed by an experienced pathologist. Synchronization of sampling which is needed for comparison was maintained in the study that provided added strength to our study.
| Conclusion|| |
Our study concluded that both Pipelle curette and Karman cannula are effective office endometrial aspiration devices that help in overcoming the drawbacks of conventional D and C procedure. In terms of ease of procedure, duration of procedure, pain, and complication during procedure, both devices had comparable results. Both devices are equally effective in identifying endometrial hyperplasia and malignancy. In terms of sample adequacy, Karman cannula was better than Pipelle curette. However, because of small sample size in our study, larger randomized controlled trial is needed to give any definitive conclusion.
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Conflicts of interest
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]