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

Phase 2

Completed

• Conditions: Oesophageal Cancer; Rectal Cancer
• Interventions: Device: radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)

• Registration Number: NCT02526134
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Status Verified: 2016-02
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laying of medical devices	radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)	radio opaque markers

Primary Outcome Measures

Name	Time	Method
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.	From inclusion to 12 months follow up	Observing whether there is a significant variation of the area to be irradiated

Secondary Outcome Measures

Name	Time	Method
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)	From inclusion to 12 months follow up	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.

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France