Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion (AGATA)

Central Hospital, Nancy, France

Status and phase: Terminated; Phase 3

Conditions: Adnexal Torsion

Treatments: Diagnostic Test: Contrast enhanced ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04522219

2020-000993-27

Details and patient eligibility

About

Clinical diagnosis of adnexal torsion is difficult because the symptomatology is dominated by abrupt onset pelvic pain, an aspecific sign which does not allow a diagnosis of certainty to be made.

To confirm the diagnosis, the reference examination is pelvic ultrasound with Doppler flow analysis. However, its intake is low, its sensitivity varies from 46 to 73% depending on the studies. Other imaging techniques have been considered, such as MRI, with a sensitivity far superior to ultrasound, but its difficult accessibility, in particular in the context of an emergency, makes it unusable in clinical practice.

The use of ultrasound with the injection of an ultrasound contrast agent, strict intravascular, seems to be an interesting technique to assess the perfusion parameters of the ovary and improve the diagnostic sensitivity of the adnexal torsion. Its interest has already been demonstrated in the diagnosis of testicular torsion in animals but to date, no study has evaluated its contribution in adnexal torsion.

Full description

The primary objective is to evaluate the diagnostic performance of contrast enhanced ultrasound for the diagnosis of adnexal torsion in women with suspected adnexal torsion.

The secondary objectives are:

1. To describe the perfusion parameters of the ovaries by contrast enhanced ultrasound
2. To compare performance diagnosis of contrast ultrasound and bidimensional Doppler for the detection of adnexal torsion.
3. To describe the perfusion parameters of the ovarian as a function of the degree of adnexal torsion.
4. To compare perfusion parameters before and after ovarian detorsion
5. To describe perfusion parameters of the ovarian by using MicroVascular Flow technique
6. To assess the contribution of qualitative contrast ultrasound for the diagnosis of adnexal torsion (without clinical context)
7. To assess inter-observer agreement on the qualitative analysis of ultrasound, without clinical context and then with clinical context.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Woman over 18 years old
• Woman affiliated to a social security
• Woman having received complete information on the organization of the research and having given her informed consent in written form.
• Planned surgical intervention for suspected adnexal torsion

Exclusion criteria

• Patients under a measure of legal protection,
• Contraindication to contrast injection Hypersensitivity to sulfur hexafluoride or any of the other ingredients, history of cardiac disease, respiratory distress syndrome, severe pulmonary hypertension..

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Case group

Experimental group

Description:

Diagnosis of adnexal torsion confirmed by the surgical intervention: woman allocated to case group

Treatment:

Diagnostic Test: Contrast enhanced ultrasound

Control group

Experimental group

Description:

Diagnosis of adnexal torsion not confirmed by the surgical intervention: woman allocated to control group

Treatment:

Diagnostic Test: Contrast enhanced ultrasound