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| Name | Class |
|---|---|
| IRCAD | UNKNOWN |
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The complexity of the medical expertise required for endoscopic manipulation and image interpretation complicates the implementation of echo-endoscopy (or EUS for "Endoscopic Ultrasound").
The "EZ-EUS" system is designed to help the operator understand the orientation and the position of the probe tip in the patient. This system offers navigation similar to that of the Global Positioning System (GPS), but for EUS procedures. To achieve this, it uses a 3D model based on scanner imaging data recorded before the procedure.
In this study, the intended purpose of the "EZ-EUS" system is to help echo-endoscopy operators to easily identify and assess the pancreatic gland, and to facilitate the detection of any lesions.
The hypothesis is that, thanks to this tool, procedure times will be shortened, and the pancreas and its lesions will be fully imaged to facilitate their localization and characterization.
Since its inception in the 1980s, the field of endoscopic ultrasound (EUS) has experienced significant expansion and evolution and is now a pivotal component of pancreatobiliary assessment. Proficiency in EUS necessitates a synthesis of cognitive and technical competencies encompassing endoscopic manipulation, image interpretation, and an extensive comprehension of intraabdominal anatomical structures. Acquisition of these competencies is a progressive and highly operator-dependent process, and thereby necessitates an extended learning curve for practitioners.
The American Society for Gastrointestinal Endoscopy (ASGE) has recommended the performance of a minimum of 190 supervised EUS for practicing autonomous EUS. However, the compliance of these parameters does not guarantee competence achievement, and there is a wide variability between endoscopists leading to disparities in the techniques' quality and irregular outcomes.
The "EZ-EUS" system is designed to help the operator understand the orientation and the position of the probe tip in the patient. This system offers navigation similar to that of the Global Positioning System (GPS), but for EUS procedures. To achieve this, it uses a 3D model based on scanner imaging data recorded before the procedure.
In this study, the intended purpose of the "EZ-EUS" system is to assist echo-endoscopy operators in accurately locating the pancreatic gland, conducting a comprehensive evaluation of the region of interest, and facilitating the detection and identification of lesions within it. We hypothesize that this tool will streamline procedure times and enable comprehensive imaging of the pancreas and its lesions, thereby reducing the need for expert guidance for trainees and shortening the EUS learning curve. This study is exploratory, prospective, monocentric and will compare two randomized groups (with and without the EZ-EUS navigation system).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS with EZ-EUS navigation system | Experimental | EUS with the experimental navigation system |
|
| Standard EUS | No Intervention | EUS in standard condition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic ultrasound with navigation system | Device | Use of the EZ-EUS navigation system during the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the EUS navigation system's procedure duration compared to standard procedure times | Comparison of the examination period duration between the two groups (experimental vs control) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the EUS navigation system for patient safety | Rate of adverse events, adverse device effects and complications | 1 month |
| Assessment of the system's ease-of-use and technological maturity |
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Inclusion Criteria:
Exclusion Criteria:
Perprocedure exclusion criteria
• Patient in need of the balloon during the navigation will be excluded of the study (Experimental group)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armelle TAKEDA, PhD | Contact | +33390413608 | armelle.takeda@ihu-strasbourg.eu |
| Name | Affiliation | Role |
|---|---|---|
| Leonardo SOSA-VALENCIA, MD | IHU Strasbourg, HUS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67000 | France |
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| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019160 | Endosonography |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Qualitative assessment of the system's ease-of-use and technological maturity using questionnaires. Appropriate statistical test will be used to compare each procedure. Results will be presented numerically and graphically.
| 1 day |
| Assessment of the EUS navigation system for reliability | Rate of device deficiencies during the procedure | 1 day |
| Evaluation of the time required to perform individual step duration | Comparison of the duration of each individual step | 1 day |
| Recording of procedure data for offline systeme performance assessment | Collection and prospective review of EUS data, including video and electromagnetic coordinates provided by the sensor | 1 day |
| Assessment of the registration method | Quantitative (numerical) assessment of registration accuracy using Target Registration Error (TRE), defined as the distance between the predicted 3D location of an anatomical landmark by the navigation system and its true 3D location | 1 day |