Ulriikka CHAPUT
Paris, 75012, France
NCT Number: NCT03057288
It is a multicenter prospective observational study including consecutive patients with esophageal tumor or rectum with indication for radiotherapy
The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance. The evaluation criteria are:
* Success rate evaluation of the placement of two markers : one in the upper part of the tumor and one in the lower part. Success of the procedure will be evaluated by the endoscopist at the end of the procedure. Pictures of the markers will objectify the good placement of the markers. * Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers * The length of the procedure * The costs (procedure, hospitalization) * The clinical efficacy, by studying the decrease of the estimated target volume, the decrease of the dose delivered to the healthy tissue and the improvement of positioning of the irradiation beams by the radiotherapy technician * The presence of the markers at the end of the radiotherapy
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75012, France
The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance.
The secondary objectives are to evaluate :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance for patients with esophageal or rectal cancer with an indication of radiotherapy
Time frame: At the end of the endoscopic procedure, up to 2 hours
One marker in the upper part of the tumor and one in the lower part. Success of the procedure will be evaluated by the endoscopist at the end of the procedure. Pictures of the markers will objectify the good placement of the markers.
Time frame: Day 1, Day 30 and Day 90
phone contact clinical examination at Day 1, clinical examination at day 30 and at the end of the radiotherapy treatment (day 90)
Time frame: the endoscopic procedure, up to120 minutes
Duration in minutes of the endoscopic procedure
Time frame: up to two days of hospitalization without any complication
sum of all costs : hospital stay, endoscopic procedure, fiducial markers
Time frame: Clinical examination with the radiotherapist, up to 30 minutes
Before starting the radiotherapy, the target volume will be estimated with and without fiducial markers, thus estimating the decrease of the estimated target volume and the decrease of the dose delivered to the healthy tissue
Time frame: Clinical examination at the end of the radiotherapy with CT scan or MRI, up to 90 days
Visualization of the fiducial markers on CT scan or MRI
Société Française d'Endoscopie Digestive
Other
Prospective Study Evaluating the Feasibility of Fiducial Markers Placement Under Echoendoscopy (EUS) Guidance for Patients With Esophageal or Rectal Cancer With an Indication of Radiotherapy
Acronym: FIDECHO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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