Clinical trial NCT03120078: A Prospective Study of Diagnostic Accuracy of Ultrasound
Official title: Diagnostic Accuracy of Ultrasound for Adenomyosis, Development of Scoring System and Correlation With Various Pelvic Pathologies: a Prospective Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adenomyosis
Keywords: Ultrasound
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing hysterectomy for with AUB or pelvic pain will be enrolled in the study.

Brief summary: Prospectively-Patients undergoing a hysterectomy for abnormal uterine bleeding (AUB) or pelvic pain will be enrolled in the study, will get pelvic ultrasound at the ultrasound clinic. An ultrasound will be obtained as part of the required clinical assessment before the patient undergoes a hysterectomy. The ultrasound images will be reviewed using Viewpoint reporting system-various sonographic features of adenomyosis will be reported detailed, including pelvic pathology, pelvic congestion syndrome etc. The histopathological examination will be done by assigned pathologist for accurate mapping/localizing the adenomyosis (appropriate section of uterus to defining localized versus generalized adenomyosis) on all patients diagnosed with adenomyosis on ultrasound. The ultrasound will be correlated with histopathology(which is the gold standard for diagnosis of adenomyosis). Scoring system for adenomyosis based on various sonographic features/clinical symptoms and their confirmation with histopathology will be developed.

Detailed description: The association between adenomyosis, assisted reproductive technology (ART) outcomes and pregnancy complications is well established.

Adenomyosis uteri is a common gynecologic disorder with unclear etiology, characterized by the presence of hetero- topic endometrial glands and stroma in the myometrium with adjacent smooth muscle hyperplasia, defined histopathologically. Uterine adenomyosis is relatively frequent, and the diagnosis is more often made in multiparous patients in their fourth and fifth decade of life. It has been noted in 20% to 30% of the general female population and in up to 70% of hysterectomy specimens, depending on the definition used.

Accurate diagnosis and localization of the disease is important, in particular when fertility conservation is warranted. Management options include medical therapy and surgery. Medical therapies target symptomatic relief and include oral contraceptive agents, progestin therapy including the levonorgestrel-releasing intrauterine system, danazol, gonadotropin-releasing hormone agonists, and aromatase inhibitors. More uterine sparing surgical options are investigated for treatment of adenomyoisis. Surgical management can be divided into uterine sparing options such as hysteroscopic or laparoscopic resection of focal disease, endometrial ablation, uterine artery embolization, and MRgFUS, or definitive treatment via hysterectomy. The sensitivity and specificity of MRI in diagnosing adenomyosis range from 88% to 93% and 67% to 91%, respectively. Ultrasound has limitation especially when myomas are associated with adenomyosis in 36% to 50% of cases, making MRI an ideal imaging method in that scenario. The sensitivity of ultrasound to detect adenomyosis ranges from 65% to 81%, and specificity ranges from 65% to 100%. A recent meta-analysis on the accuracy of ultrasound in the diagnosis of adenomyosis demonstrated sensitivity of 82.5% (95% confidence interval, 77.5-87.9) and specificity of 84.6% (95% confidence interval, 79.8-89.8), with a positive likelihood ratio of 4.7 (3.1-7.0) and negative likelihood ratio of 0.26 (0.18-0.39), comparable to MRI.

Adenomyosis is a heterogeneous entity and thus its sonographic appearance is also variable. The variation in the degree of invasion and the heterogeneity in the reaction of surrounding tissue account for the ultrasound findings of adenomyosis. It manifests most commonly as a diffuse disease involving the entire myometrium and commonly involves the posterior uterine wall. It can also present as a localized focal entity known as nodular adenomyosis or an adenomyomas.

Following are common sonographic features of adenomyoisis.

1. Heterogeneous Myometrium: Lack of homogeneity within the myometrium, with evidence of architectural disturbance with increased and decreased echoes. This is most predictive of adenomyosis.
2. Loss of endometrium-myometrium border: Invasion of the myometrium by the glands also obscures the normally distinct endometrium-myometrium border, making it difficult to measure. This is a layer that appears as a hypoechoic halo surrounding the endometrial layer. In the past this was obtainable only with MRI; however, with newer high-resolution ultrasound, in particular using 3D rendering, it is now possible to visualize this layer. Thickness \>8 to 12 mm is associated with adenomyosis.
3. Echogenic linear striations: Invasion of the endometrial glands into the subendometrial tissue induces a hyperplastic reaction that appears as echogenic linear striations fanning out from the endometrial layer.
4. Asymmetrical Uterine wall thickening: anteroposterior asymmetry, in particular when the disease is focal.
5. Color Doppler ultrasonography can also be used to differentiate adenomyosis from leiomyomas. Random scattering of vessels or intramural signals in adenomyosis cases. In contrast, in leiomyoma cases the vessels were peripheral or outer feeding vessels.

The investigators are trying to see what are the most common sonographic features of adenomyosis.

There is no clear terminology and consensus on classification of adenomyoisis on ultrasound images. Since this is a heterogeneous condition, significantly affects reproduction and newer specific uterine sparing options warrants correct localization and subclassify the disease burden like overt adenomyoisis versus localized adenomyomas. Also recently there is evidence that adenomyoisis is a progressive disease.

Presented data will aid in development of the integrated scoring system for detection and objective assessment of adenomyosis.

Eligibility criteria: Inclusion Criteria:

* Women
* 18 years or older but 60 years or less.
* Undergoing hysterectomy for AUB or pelvic pain

Exclusion Criteria:

* known cause of AUB or pelvic pain

Primary outcomes:
measure: Develop a scoring system for adenomyosis based on various sonographic features and clinical symptoms.
timeFrame: Duration of Study
Secondary outcomes:
measure: Review the diagnostic accuracy of ultrasound with adenomyosis.
timeFrame: Duration of study
measure: Prevalence of coexisting pathology.
timeFrame: Duration of Study
measure: Menstrual bleeding questionnaire
timeFrame: Duration of Study
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Science Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center, El Paso
name: Sushila Arya, MD
role: PRINCIPAL_INVESTIGATOR
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