Clinical trial NCT04522219: Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion
Official title: Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion: a Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Adnexal Torsion
Keywords: adnexal
torsion
ovarian
contrast enhanced ultrasound
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Phase 3b, prospective, Case-Control study
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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..

Primary outcomes:
measure: Signal intensity measurement
timeFrame: through study completion, on average of 36 months
Secondary outcomes:
measure: vascularization of the ovaries on contrast enhanced ultrasound.
timeFrame: through study completion, an average of 36 months
measure: diagnostics performance
timeFrame: through study completion, an average of 36 months
measure: vascularization of the ovaries according to the degree of torsion
timeFrame: through study completion, an average of 36 months
measure: vascularization of the ovaries before and after detorsion
timeFrame: through study completion, an average of 36 months
measure: Micro Vascular Flow technique
timeFrame: through study completion, an average of 36 months
measure: Qualitative evaluation of contrast enhancement
timeFrame: through study completion, an average of 36 months
measure: Reproducibility of qualitative evaluation of contrast enhancement
timeFrame: through study completion, an average of 36 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Charline BERTHOLDT
role: STUDY_CHAIR
References: