Lupine Publishers | Evaluation of The Efficacy of Pipelle In Diagnosis of Endometrial Lesions in Cases of Perimenopausal Bleeding
Lupine Publishers | Interventions in Gynecology and Women's Healthcare
Abstract
One of the most common gynecologic complaint is irregular uterine bleeding It is one of the most common Problem in the perimenopausal and postmenopausal years. It has a direct impact on woman physical, social, emotional and material quality of life. While vaginal bleeding is the sign of endometrial cancer in more than 90% of postmenopausal women which is the sixth most common malignant neoplasm in women worldwide and is the most common gynecologic malignancy in developed countries, therefore, the diagnosis of AUB needs to be undertaken seriously. This study was implemented to evaluate the efficacy of suction pipelle-which is an endometrial sampling technique- in diagnosis of endometrial lesions in cases of abnormal uterine bleeding. It was designed as a cross sectional study and included 184 patients complaining of AUB. 2 samples were taken from all candidate women one by D&C and the other was by pipelle device and the results of histopathological examination of both were compared regarding that D&C was the gold standard. After statistical analysis of the present study by SPSS version 23 software, the 2 methods were 100% matched in diagnosis of secretory endometrium, hormone dependent endometrium, atypical hyperplasia and EEC grade 1. The pipelle succeeded to diagnose some cases of proliferative endometrial and simple hyperplasia which were missed by D&C (18.5% and 17.4% by pipelle versus 16.3% and 13% by D & C respectively). Unfortunately, there were cases the pipelle failed to diagnose, as in some cases of endometrial polyp and disordered endometrial hyperplasia which diagnosed by D&C (8.7% and 17.4% by pipelle versus 16.3% and 19.6% by D& C respectively).
Conclusion: Pipelle is an outpatient procedure which avoids general anesthesia and its related risks, does not need room or personnel in the operating theatre, is less painful, is more cost-effective and obtains an accurate specimen with consistent histopathology results compared to D&C. It would, however, have decreased sensitivity for endometrial polyp diagnosis and hyperplasia.
Introduction
Abnormal uterine bleeding (AUB) is a
significant clinical entity complaint among women in reproductive age attending
to an outpatient clinics [1] it may have a significant impact on woman
physical, social, emotional and material quality of life along with the direct
impact on the woman and her family, there are significant costs to both economy
and health service [2]. AUB is an abnormal uterine bleeding that occurs in the
absence of identifiable pathology. This represents a disturbance to the
endometrial lining of the normal cyclic of ovulatory hormonal stimulation. In
many cases, the bleeding is unpredictable. It can be too heavy or light and
prolonged, irregular, or random [3].
The working group on menstrual disorders of the International Federation of
Gynecology and Obstetrics, FIGO, has recently developed a classification system
(PALM-COEIN) for AUB causes in non-gravid women of reproductive age. There are
nine main categories grouped under the acronym PALM-COEIN: polyp; adenomyosis;
leiomyoma; malignancy and hyperplasia; coagulopathy; ovulatory dysfunction;
endometrial; iatrogenic; and not yet classified [4]. Endometrium assessment
methods are numerous in patients with abnormal uterine bleeding, these are
ultrasonography, D&C, office-based methods as hysteroscopic biopsy or
endometrial samplers such as suction pipeline [5]. In women with abnormal
uterine bleeding, the main cause for performing endometrial biopsy is to
confirm the benign nature of the problem by excluding endometrial carcinoma so
appropriate management can be [6] Throughout decades, the endometrial curettage
is the gold standard endometrial sampling tool. However, in sixty percent of
cases, it can lead to less than 50% curettage of endometrium and is also
accompanied by infection risk and perforation. It also requires hospital
admission and local or general anesthesia [5].
Aim of the Work
Evaluation of the efficacy of suction pipelle in diagnosis of endometrial lesions in patients with abnormal uterine bleeding
Patients and Methods
Conclusion
The study was Cross sectional study
carried out at Gynecology and Obstetrics Department, Armed Forces Hospitals of
South Region. Gazan, KSA. during the period from April 2017 to May 2019. 184
patients included in this study they had Abnormal vaginal bleeding although
medical therapy.
Exclusion criteria:
a. Lower genital tract infection.
Local gynecological cause.
b. Patients with bleeding disorders (Coagulopathy, thrombocytopenia (less than
100/000 platelet per mm3).
c. Use of anti-coagulants.
d. Bleeding due to endocrinological disorders (thyroid diseases and diabetes)
or due to liver or renal impairment.
e. An informed verbal and written consent were obtained from every subject.
All cases who met inclusion criteria were subjected to the following:
History
Full history was taking including: personal, present, past, family, obstetric, history of drug intake, contraceptive and menstrual history.
Detailed History about duration, amount and pattern of bleeding.
Examination
General examination: Including Blood pressure, pulse, temperature and respiratory rate.
Abdominal examination: Evaluation of fundal level. Presence of any scars of previous operations.
Laboratory investigation: CBC will be conducted, coagulation profile, hormonal assay consisting of thyroid function tests, serum prolactin, liver and kidney function tests. Transvaginal ultrasonography TVS for assessment of myometrium, endometrial thickness and uterine cavity. On the day of operation and after vaginal washing and speculum placement in lithotomy place, patients are moved to the operating room. the sampling was performed preceding to anesthesia, dilatation and using of suction pipelle. The sheath piston was drowned back to make negative gradient after the pipelle was inserted into the uterine cavity and then the pipelle was slowly removed. The procedure was repeated more than one as much if the sample was insufficient. In container A, the samples were collected. Using the curette number 3 or 4 and the samples were assembled in container B. The samples were sent to the same pathologist for histopathological evaluation. Patients and pathologists were blinded about the sampling sequence and the sampling method used for each sample.
Results
The mean of 54.8 years, parity of the studied group ranged from 0 to 5 times, and 48.9% of them were obese and 31.5% were overweight (Table 1). The mean duration of bleeding ranged from 7 days up to 90 days with mean of 23.8 days, endometrial thickness of the studied group ranged from 6 to 15mm, and 76.1% of them were pre-menopause (Table 2). The most common presented symptoms among the studied group was menorrhagia among 42.4% of them, then 30.4% presented with poly-menorrhagia and 16.3% with metrorrhagia (Table 3). The results of D & C and pipelle device, they were matched in detection of secretory endometrium, hormone dependent endometrium, atypical hyperplasia and EEC grade 1, while there was over estimation of positive proliferative endometrial cases and simple hyperplasia by pipelle device (18.5% and 17.4% versus 16.3% and 13% respectively by D&C), also it miss cases of endometrial polyp and disordered endometrial hyperplasia (8.7% and 17.4% versus 16.3% and 19.6% respectively by D& C) (Table4).
Table 1: Comparison between the studied groups regarding the demographic and obstetric history.
Table 2: Comparison between the studied groups regarding the presenting symptoms.
Table 3: Comparison between the studied groups regarding the pre-operative data.
Table 4: Comparison between the studied groups regarding the operative data.
The sensitivity of pipelle sampling was 100% in detecting proliferative, secretory, hormonal dependent endometrium, simple and atypical hyperplasia and EEC grade 1, while it was 89% for the detection of disordered endometrium and 53.3% only for detection of polyp (Table 5).
Table 5: Comparison between the studied groups regarding the post-operative data.
Discussion
Abnormal bleeding is the presenting
sign in more than 90% of perimenopausal women with cancer of the endometrium
[7]. Endometrial cancer is the sixth most common malignant neoplasm in women
worldwide and is the most common gynecologic malignancy in developed countries
[8]. Therefore, the management of AUB needs to be undertaken seriously. There
are many methods of endometrial assessment in patients with abnormal uterine
bleeding, including ultrasonography, D&C, office-based methods, including
hysteroscopic biopsy or endometrial samplers such as suction pipelle [6].The D
& C is the most conventional method of endometrial sampling which is in
vogue since many decades. Though, it offers a high degree of sensitivity in
diagnosis of endometrial lesions, the associated surgical risks, postoperative
pain, higher costs due to hospitalization and anesthesia have necessitated the
search for a suitable substitute which is simpler, cheaper, non-invasive, free
of complications and offers good diagnostic accuracy [6]. The advent of
non-invasive office procedures like pipelle endometrial sampling has posed a
challenge to the whole range of conventional invasive techniques. It is now
widely accepted by the clinicians and patients, since Its safe and economical.
It can sample about 5-15% of the total endometrial surface area. It is
especially useful in global lesions involving in large surface area of the
endometrium than in focal lesions [7]. Hence, our study was proposed to
evaluate the efficacy of Pipelle sampling in diagnosing endometrial pathologies
in comparison with gold standard D and C method. The aim of this study was to
Compare between the histopathological findings of pipelle endometrial biopsy
and D&C biopsy (the gold standard).
Regarding the clinical features of the study population; we work on 184 cases
their age was ranged from 44 years up to 66 years with mean of 54.8 years,
their parity is ranged from 1 to 5 with mean of 1.8, and according to BMI, 36
cases (19.6%) were normal (BMI; 18-25), 58 cases (31.5%) are overweight (BMI;
25-30) and rest of cases (90 case, 48.9%) are obese (BMI: more than 30) from
that it seems that most of patients were obese. In comparison with a study
performed in Iran by Moradan et al., 2015 on 130 patients, similar data have
been observed, as the mean age of the study group was 46.19 years. The mean
parity was 2.9 ranging from 1 to 5 time [9,10]. Our data is also agreed with
data obtained from a study performed in Kuwait by Abdelazim et al. [11] on 143
cases as it shows that, the mean age of the study group was 46.3 years ranging
from 40 to 49. The mean parity was 4.7 ranging from 1 to 6 time. Regarding to
menopausal state of our studied group, most of cases were pre-menopause with
percentage of 76.1%, the rest of cases were post-menopause. It was to somehow
consistent with that in another study as the percentage of pre- menopause was
62.3%.
The most common presenting symptoms among our studied group was menorrhagia 78
cases (42.4%), 56 cases (30.4%) presented with Polymenorrhea, 30 cases (16.3%)
presented with metrorrhagia and finally 20 cases (10.9%) presented with
Post-menopausal bleeding [9]. There were slight differences in the percentage
of the common presentation among patients included in the above study as
Menorrhagia was the most common presenting complaint seen in 116 cases
(55.24%), but against to our findings it was followed by metrorrhagia in 48
(22.86%) cases, then Polymenorrhagia in 28 (13.33%) cases and postmenopausal
bleeding in 18 (8.57%) cases. In comparison with the study by Abdelazim et al.
[11]. the presenting symptoms were menorrhagia 37%, poly-menorrhagia 25.8%,
metrorrhagia 18.1% and Postmenopausal bleeding 16.7%, like our results.
In our study tissues obtained for histopathology were mostly enough in both
methods, sample sufficiency was 97.9% for D & C as there were only 4
insufficient samples while in pipelle sampling it was 94.6%, 5 samples are in
insufficient. In comparison with the study by Alliratnam AS et al. [12] Sample
sufficiency was 96% for D & C versus 93% for Pipelle. While in Moradan et
al., 2015 study 84.6% of the samples obtained by Pipelle and 90% of those
obtained by D& C were enough. Similar results have been observed in Abdelazim
et al. [11]. study, Sample sufficiency was 100% for D & C versus 97.9% for
Pipelle.
Also, similar results were reported in a study by Naderi et al. [13] the
sufficiency rates were 91.6% and 98.3% by Pipelle and D & C respectively.
Regarding pathology of endometrial tissue obtained by D&C and pipelle; our
study showed that, the 2 methods were matched in detection of secretory
endometrium, hormone dependent endometrium, atypical hyperplasia and EEC grade
1, while there was over estimation of positive proliferative endometrial cases
and simple hyperplasia by pipelle device (18.5% and 17.4% versus 16.3% and 13%
respectively by D&C), also it miss cases of endometrial polyp and
disordered endometrial hyperplasia (8.7% and 17.4% versus 16.3% and 19.6% respectively
by D&C).
The results of endometrial sampling were also to somehow similar to Alliratnam
et al. (12). study, Histopathological examination revealed that both methods
agreed in all cases of secretory endometrium and adenocarcinoma, and there was
over estimation of positive in diagnosis of proliferative endometrium by
pipelle device, only 1 missed case by pipelle in diagnosis of disordered
endometrium, but it failed to diagnose any case of endometrial polyp, thus
polyp is rarely to be detected by pipelle in this study and proliferative
endometrium is the commonest cause of peri-menopausal bleeding in this study.
In Moradan et al., 2015 study, the pipelle missed only few cases in diagnosis
of secretory endometrium and endometrial hyperplasia without atypia (27.7% and
16.9% versus 28.5% and 18.5% by D&C), but they were agreed in diagnosis of
malignant endometrium, and pipelle positively overestimated the diagnosis of
proliferative endometrium [10]. The results were similar to Abdelazim et
al[11]. study who found that there was positive correlation between 2 methods
in diagnosis of proliferative endometrium, secretory endometrium, endometrial
hyperplasia with atypia and malignant endometrium, but the pipelle missed the
diagnosis of some cases of endometrial hyperplasia without atypia and
endometrial polyps (34.3% and 2.1% versus 31.4% and 0.7% by D&C). Our study
disagrees with Demirkiran et al. [14]. study on 478 patients. Histopathological
examination of D & C biopsy showed normal endometrium in 330 cases (69%) ,
hyperplasia in 21 cases (4.4%), hyperplasia with atypia in 20 cases (4.2%),
focal lesions in 89 cases (18.6%) , atrophy in 9 cases (1.9%) and insufficient
in 9 cases (1.9%), while Pipelle method showed; normal endometrium in 356 cases
(74.5%) , hyperplasia in 22 cases (4.6%) , hyperplasia with atypia in 18 cases
(3.8%),focal lesions in 59 cases (12.3%), atrophy in 7 cases (1.5%) and
insufficient in 16 cases (3.3%).
Regarding validity; Our study showed good agreement between Pipelle and D&C
in detection of endometrial abnormalities; the sensitivity of pipelle sampling
was 100% in detecting proliferative, secretory, hormonal dependent endometrium,
simple and atypical hyperplasia and EEC grade 1, while it was 89% for the
detection of endometrium disorders and 53.3% only for detection of polyp.
In support of our finding’s validity of Pipelle in Alliratnam et al. [12] study
was as following; Pipelle has sensitivity of 100% in proliferative endometrium,
secretory endometrium and Adenocarcinoma, while it had 90% sensitivity in
disordered proliferative endometrium diagnosis and only 16% in endometrial
polyp detection .Similar results have been observed in Moradan et al., 2015
study as following; pipelle has sensitivity in proliferative endometrium
(94.4%), secretory endometrium (97.4), simple endometrial hyperplasia without
atypia (92.3%), endometrial cancer (100%) and atrophic endometrium (50%) (10).
Our results are also consistent to somehow with Abdelazim et al. [11] study
results as pipelle showed sensitivity of 100% in proliferative endometrium,
secretory endometrium, endometrial hyperplasia and endometrial carcinoma and
only 60% in detection of endometrial polyp . On the other hand, the current
study disagrees with Demirkiran et al. [14]. In the detection of endometrial
hyperplasia, which was lower than our study, they reported a sensitivity level
of 67% for Pipelle biopsy. The source of discrepancies is the recognition of
different age groups as criteria for inclusion in this and another research.
The other probable cause is difference in curette and Pipelle that is used by
different studies.
Conclusion
With regard to the facility to perform sampling as an outpatient procedure and without anesthesia and with short duration and less cost, it is recommended that this device be used instead of D & C. lesion like polyps and focal lesions may missed by pipelle. Negative biopsy must therefore be followed in a symptomatic patient by other diagnostic methods such as D&C or hysteroscopy.
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