Blob and Bagel sign on Ultrasound can be labelled as definitive for Ectopic Pregnancy

. blob sign of ectopic pregnancy.

Women with the Blob and Bagel ultrasound sign should be reclassified from having ‘probable’ ectopic pregnancy (EP) to ‘definitive’ EP and should be treated as such reports the result of a large retrospective cohort study published March 11, 2018, in Journal of Ultrasound in Obstetrics and Gynecology.

Ectopic Pregnancy is still the leading cause of first-trimester maternal deaths and constitutes 4% of all pregnancy-related deaths. The incidence of ectopic is highest in women undergoing In-Vitro Fertilization(IVF) and ranges from 4% to 11% of all pregnancies.

The broken arrow depicts the right ovary and the solid arrow shows ectopic pregnancy characterized by the ‘bagel sign’.

With the advent of high-resolution transvaginal ultrasound (TVS), more ectopic pregnancies are diagnosed at clinically early and hemodynamically stable stages that are amenable to various modes of management. In modern times TVS has replaced laparoscopy as the diagnostic tool of choice.

Barnhart et al have published a recent consensus statement of nomenclature, definitions, and outcome of pregnancy of unknown location (PUL) in Journal Fertility and Sterility. In which, research papers originating from the US diagnose EP based on findings of an extrauterine gestational sac with the visualization of a yolk sac or embryo, while literature from the UK and European countries diagnose EP based on finding of an extrauterine inhomogeneous mass (blob sign), or an extrauterine empty gestational sac (bagel sign). 

   

This study was undertaken with an aim to determine whether these ultrasound markers can be used to definitely predict EP, instead of just raising a probability of its presence. The study recruited 849 of 7490 consecutive women who attended the Early Pregnancy Unit (EPU) of the Nepean Hospital, Sydney, Australia over a period of 10 years.

At TVS, 240 of 849 women were diagnosed as probable EP, of which 174 (72.5%) exhibited the blob sign and 66 (27.5%) exhibited bagel sign. The rest 609 were labeled as PUL, of which 47 received a final diagnosis of EP (including 24 blob signs, 19 bagel signs and four gestational sacs with embryo/yolk sac.

Nearly 51% of patient with blob sign and 59% of patients with bagel sign underwent laparoscopic salpingectomy, and HPE proved the diagnosis in 97% of patients with blob sign and 96% of patients with bagel sign.

The sensitivity for the blob and bagel signs in the prediction of definite tubal EP was 89.8% and 83.3%, respectively, the specificity was 99.5% and 99.6%, PPV was 96.7% and 95.2% and NPV was 98.3% and 98.6%.

All the parameters were comparable to the corresponding parameters of the extrauterine gestational sac with yolk sac and/or embryo on TVS used in the prediction of definite tubal EP.

The authors concluded that Blob and bagel signs are the commonest presentation of tubal ectopic on TVS, and because of high PPV of >95%, it can be used for the definitive diagnosis of EP. Majority of women who present with EP during early pregnancy can have a definitive diagnosis with only standalone TVS, with laparoscopy being used as the treatment modality.

Abstract

Consensus statement

Media courtesy: Wikimedia Commons, research gate 

News from NAMS 2017: Postmenopausal bleeding is always a red flag, unless proven benign

Every postmenopausal bleeding mandates a complete and systematic investigation to rule out endometrial malignancy and blind biopsies are no longer the norm, according to a presentation by Steven R. Goldstein, MD, a professor of obstetrics and gynecology at New York University School of Medicine, New York City here at the North American Menopause Society (NAMS) 2017 Annual Meeting.

“If you’re postmenopausal and not on hormone therapy or tamoxifen, you shouldn’t be bleeding,” he further added.

American Cancer Society estimates that in year 2017, about 61,380 new cases of endometrial cancer and uterine sarcoma will be diagnosed and about 10,920 women will die from these cancers. The average age at diagnosis is 60 and postmenopausal bleeding is the most common presentation in nearly all the cases.

In majority of women who present with postmenopausal bleeding, the cause is atrophic changes of endometrium or vagina, but depending upon other risk factors, 1-14% of these women will harbor a malignancy and it is important not to miss these women.

ACOG advocates endometrial evaluation in any women presenting with abnormal uterine bleeding (AUB), but blind biopsy is no longer sufficient in ruling out uterine malignancy.

Blind biopsy alone could miss the diagnosis of focal lesions in up to 18% of patients
Endosee

Dr Goldstein said, “The standard of care has changed. Now the standard of care corroborates that a negative blind biopsy is not a stopping point. Clinicians can still begin with a blind biopsy, but unless it is malignant or complex atypical hyperplasia, the endometrial evaluation is not complete."

If cancers occupy less than 50% of the surface area of the uterine cavity, it can very much be missed with a blind biopsy.

if cancer occupies less than 50%, of the surface area of the endometrial cavity, the cancer can be missed by a blind biopsy
Endosee

The Evaluation Algorithm

The investigation should ideally begin with transvaginal ultrasonography(TVS), or sonomicroscopy, to determine the thickness of the endometrium. If distinct endometrial echo or lining, less than or equal to 4 mm is visualized, no further endometrial sampling is required. (99.8%- 100% negative predictive value)

But, in many patients it is not possible to see the endometrial lining because of obesity, adenomyosis structural nonalignment or fibroids.  So, if the endometrial thickness is more than 4 mm or the endometrial echo is difficult to visualize, the next logical step is to perform a sonohysterography or hysteroscopy.

By infusing fluid, clinicians can delineate clearly whether the thickening is focal or global throughout the cavity. If the thickness is global, go for a biopsy. If it is focal occupying more than 20-30% of uterine cavity, plan for a biopsy under hysteroscopic guidance.

It’s easy and timesaving to perform office hysteroscopy, with US FDA approved disposable hysteroscope called Endosee (Cooper Surgical). It provides a quick point of care option and does not require sterilization or special storage. Physicians can take a biopsy under direct vision and resolve the dilemma.

If the patient’s first point of contact is not an obgyn but a primary care physician, an internist or physician from some other specialty, they should at least order a TVS, so that by the time the patient is seen by a gynecologist, the initial sonography report is ready.

NAMS press release

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Reassessment of endometrial thickness for detecting endometrial cancer in post menopausal bleeding: a retrospective cohort study.

Postmenopausal bleeding (PMB) accounts for 5% of all gynecological consultations out of whom nearly 10% will be diagnosed with endometrial cancer as the cause of bleeding making it to be the most common malignancy of female genital tract.

Endometrial cancer is the fourth most common cancer in females in the UK (2012), accounting for 5% of all new cases of cancer in females.

The liberal use of Transvaginal Ultrasound (TVS) as the first line of investigation in patients with PMB has decreased the use of more invasive procedures like endometrial sampling and hysteroscopy.

Based on the very high negative predictive value of TVS, ACOG recommended a cutoff of 4 mm for endometrial thickness: That is, endometrial stripes 4 mm or thinner require no endometrial sampling; only those thicker than 4 mm require a biopsy.

RCOG guidelines for investigation of PMB have also set the arbitrary cutoff at 4-5 mm by TVS at which the women can be reassured.

However, the endometrial thickness cutoff and the need for further investigation are being debated since very long.

A literature review showed that 4 different meta-analysis have been published on this subject showing varying conclusions. All 4 Meta analyses suffered from various biases like verification bias because the endometrial biopsy was conditioned upon the endometrial thickness by TVS.

A recent study by Wong et al published in the February issue of BJOG:An International Journal of Obstetrics & Gynaecology and the Mini Commentary is unique because it constituted the largest cohort of women (4383 women) with PMB, in whom endometrial biopsy was performed independent of the endometrial thickness by TVS. Endometrial histology results were used as the reference standard to calculate accuracy estimates.

Endometrial cancer was diagnosed in 3.8% of all the women, with a median endometrial thickness of 15.7 mm which was much higher than that found in benign conditions (3.2mm).

The sensitivity for the diagnosis of endometrial cancer at 3, 4 and 5mm cutoff were 97%, 94.1% and 93.5% respectively with corresponding estimates for specificity 45.3% ,66.8% and 74.0% respectively.

According to this study the optimal threshold that combines the perfect sensitivity with an acceptable specificity appears to be 3 mm.

At this cut-off point, positive and negative predictive values were 6.5 and 0.26%.

Although the strategies to diagnose endometrial cancer by TVS are well documented, further improvement can be achieved by adding patient’s characteristics and individual risk factors to decide the need and type of testing required.

This study and the resulting data can further validate and add to the existing prediction models to maximize the probabilities of pre and post test diagnosis of endometrial cancer!

This will in turn be able to pinpoint women who are least likely to have endometrial cancer based on TVS screening, avoiding unnecessary invasive surgeries.

References:

Wong AS-W, Lao TT-H, Cheung CW, Yeung SW, Fan HL, Ng PS, Yuen PM, Sahota DS. Reappraisal of endometrial thickness for the detection of endometrial cancer in postmenopausal bleeding: a retrospective cohort study. BJOG 2016;123:439–446.

Breijer, M. and Mol, B. (2016), Transvaginal ultrasound measurement of the endometrium remains the first line test for investigating postmenopausal bleeding but integration of patient characteristics into testing may further improve diagnostic algorithms. BJOG: An International Journal of Obstetrics & Gynaecology, 123: 447. doi: 10.1111/1471-0528.13438

http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/uterine-cancer/incidence#heading-Zero

http://www.birminghamcancer.nhs.uk/uploads/document_file/document/4e804e79358e9802e300014b/guideline_for_the_managment_of_pmb_-_version_3.0.pdf

http://seer.cancer.gov/statfacts/html/corp.html