Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum

Study Overview
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Brief Summary
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The purpose of this study is to estimate the rate of patients in whom a significant change in the area to be irradiated will be observed between the assessment before and after laying the evaluation of Trustees.

Detailed Description
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The centering of radiotherapy is done with the pre-radiation scanner for tracking the implementation of target skin markers. On this scanner, it is often difficult for the radiation therapist to pinpoint the target volume. To improve the definition of the target volume, image fusion techniques with other imaging tests were developed. To improve the pre-radiotherapy identification, setting up markers echo-endoscopy has been described without major complications. The impact on targeting radiotherapy was mainly described for the prostate. The marking of digestive tumors was described by the establishment of Trustees, radiopaque markers in the lymph nodes, esophagus, stomach, pancreas, and bile ducts.

Official Title
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Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum

Conditions
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Oesophageal Cancer, Rectal Cancer

Intervention / Treatment
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* Device: radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over the age of 18 Rectal cancer diagnosis or esophagus Radiotherapy indication Signed consent to participate Patient affiliated to a social security system or benefiting from such a system Exclusion Criteria: Pregnant women, of child-bearing potential, or lactating women Patient deprived of liberty or under supervision of a guardian Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons Contra-indication for procedure study (infeasible EUS) Contra-indication for general anesthesia Patient (e) with disorders of hemostasis Patient (e) with portal hypertension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laying of medical devices<br>radio opaque markers | Device: radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients rate in which a significant variation in the area to be irradiated will be observed between before evaluation and evaluation after laying the trustees. | Observing whether there is a significant variation of the area to be irradiated | From inclusion to 12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of trustees (2 up 6 maximum) and set up their positions estimated success rate of implementation and the evaluation of the safety and toxicity (complications) associated with the establishment trustees (composite measure) | Safety and security are measured by statistical analysis (numbers and percentage for qualitative variables and by average, median, standard deviations and extreme values for quantitative variables. | From inclusion to 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laying of medical devices (radio opaque markers)