Endoscopic Rectal UltraSound With Elastosonography and Contrast in Deep Pelvic Endometriosis With Bowel Involvement

September 18, 2019 updated by: VANBIERVLIET, Société Française d'Endoscopie Digestive

Place of Endoscopic Rectal Ultrasound With Elastosonography and Contrast in Diagnosis and Supported of Deep Pelvic Endometriosis With Bowel Involvement

The aim of the study will be to determine the diagnostic and prognostic value of elastosonography and the use of the contrast agent (Sonovue®) in the endoscopic ultrasound exploration of deep pelvic endometriosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

To diagnose deep infiltrating endometriosis, a clinical examination may be performed by a gynecologist to look for typical signs of endometriosis, but in 25% of case there can be absent.

According to that, medical imaging is indispensable in diagnosis of pelvic endometriosis. Trans vaginal ultrasonography, and pelvic MRI are major tools in the hands of specialists, but several studies have shown the importance of endoscopic rectal ultrasound, with a sensitivity close to 90% for de diagnosis of digestive impairment.

In recent years the use of elastography and the injection of microbubbles of sulfur hexafluoride in addition to endoscopic ultrasound has made it possible to improve the diagnostic accuracy of the technique in tumoral pathologies, in particular bilio-pancreatic injuries.

However, no study has yet evaluated the endoscopic rectal ultrasound with elastometry and injection of contrast agent to characterize the digestive lesions of deep pelvic endometriosis.

The endoscopic rectal ultrasound has demonstrated its place in the evaluation of deep pelvic endometriosis disease but its latest complementary techniques of interest have not yet been studied prospectively. The aim of the study will be to determine the diagnostic and prognostic value of elastosonography and the use of the contrast agent (Sonovue®) in the endoscopic ultrasound exploration of deep pelvic endometriosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06202
        • Hopital L'Archet 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with deep pelvic endometriosis and digestive impairment.

Description

Inclusion Criteria:

  • Woman over 18 years of age
  • Diagnosis of deep pelvic endometriosis (clinical and / or MRI and / or transvaginal ultrasound), defined by penetrating endometriosis lesions in the retroperitoneal space and / or pelvic organ wall at a depth of at least 5 millimeters , with digestive impairment.
  • Presenting symptoms of deep pelvic endometriosis disabling and / or fertility difficulties and requiring an exhaustive iconographic assessment.
  • Belong to a social security scheme.
  • Signature of informed consent.

Exclusion Criteria:

  • Without medical contraindication to the realization of a low digestive endoscopy.
  • Allergy or hypersensitivity to sulfur hexafluoride or one of the components of Sonovue® (contrast agent used in endoscopy ultrasound).
  • Severe heart rhythm disorders.
  • Angina unstable.
  • Recent Acute Coronary Syndrome.
  • Heart Shunt Right - Left.
  • Severe pulmonary arterial hypertension (PAH) (defined as PAH > 90 mmHg).
  • Acute or severe cardiac insufficiency stage 3 and 4
  • Pregnant woman and vulnerable patient population (persons deprived of administrative and / or judicial liberty, and persons under guardianship.
  • Mental disability of the subject making participation in the trial impossible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relevance of endoscopic elastosonography for description and characterization of digestive endometriosis lesions, using a ratio of elastonography.
Time Frame: 36 months
Calculate the average of the endoscopic elastosonography ratios in order to establish the hardness of the endometriosic tissues invading the digestive tract. For each lesion, a ratio of elastosonography will be calculated, averaging three elastometric measurements taken during the examination.
36 months
Relevance of EUS contrast for description and characterization of digestive endometriosis lesions.
Time Frame: 36 months
Determine the contrast agent intake, intensity, start time, and washout time, depending on the location, and the extent of the endometriosis lesion to the digestive tract. Using a scale of intensity of contrast intake (Weak, Moderate, Intense)
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between elastosonography and EUS contrast for clinical criteria using visual analog scale of pain.
Time Frame: 36 months
The first clinical criteria will be based on each patient's pain, using visual analog scale of pain, from the data collected from each patient by completing a questionnaire during the interview.
36 months
Correlation between elastosonography and EUS contrast for clinical criteria using , description of symptoms.
Time Frame: 36 months
The second clinical criteria will be based on each patient's, type of symptoms. Using the data collected from each patient by completing a questionnaire during the interview.
36 months
Correlation between elastosonography and EUS contrast for clinical criteria using scale of analgesic used.
Time Frame: 36 months
The third clinical criteria will be based on different types of drug therapy used for the pain. Using the data collected from each patient by completing a questionnaire during the interview.
36 months
Correlation between elastosonography and EUS contrast for histological criteria.
Time Frame: 36 months
The histological criteria will be established, after anatomopathological analysis of the operative part, on the hardness of the lesions, and their vascularization.
36 months
Surgical criteria
Time Frame: 36 months
The surgical criteria will be based on the type of surgery, its difficulty, and its possible complications according to Clavien d'Indo's classification.
36 months
Establish the safety of use of elastosonography and the endoscopy rectal ultrasound using contrast.
Time Frame: 36 months
The safety of use of the elastosonography and the endoscopy rectal ultrasound using contrast will be established after statistical analysis of possible side effects attributable to the procedure.Number of participants with medical procedure -related adverse events as assessed by CTCAE v4.0
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société Française d'Endoscopie Digestive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EEE2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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