A Prospective Study of Diagnostic Accuracy of Ultrasound

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Brief Title

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.

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.
    


Study Type

Observational


Primary Outcome

Develop a scoring system for adenomyosis based on various sonographic features and clinical symptoms.

Secondary Outcome

 Review the diagnostic accuracy of ultrasound with adenomyosis.

Condition

Adenomyosis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

2

Start Date

June 1, 2017

Completion Date

December 14, 2017

Primary Completion Date

December 14, 2017

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
      

Gender

Female

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sushila Arya, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03120078

Organization ID

E17057


Responsible Party

Principal Investigator

Study Sponsor

Texas Tech University Health Sciences Center, El Paso


Study Sponsor

Sushila Arya, MD, Principal Investigator, Texas Tech University Health Sciences Center, El Paso


Verification Date

April 2018