An interventional study of fiducial markers placement in Esophageal Neoplasm and Rectal Neoplasms, sponsored by Société Française d'Endoscopie Digestive. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by Société Française d'Endoscopie Digestive · Not applicable, Interventional, and Other
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:
The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance.
The secondary objectives are to evaluate :
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Société Française d'Endoscopie Digestive is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Prospective study with one arm evaluating the feasibility of fiducial markers placement under echoendoscopic guidance, for patients with esophageal or rectal cancer
Device: fiducial markers placement
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
Success rate evaluation of the placement of two fiducial markers
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: At the end of the endoscopic procedure, up to 2 hours
Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers
phone contact clinical examination at Day 1, clinical examination at day 30 and at the end of the radiotherapy treatment (day 90)
Time frame: Day 1, Day 30 and Day 90
The length of the procedure
Duration in minutes of the endoscopic procedure
Time frame: the endoscopic procedure, up to120 minutes
The costs (procedure, hospitalization)
sum of all costs : hospital stay, endoscopic procedure, fiducial markers
Time frame: up to two days of hospitalization without any complication
The clinical efficacy, by studying the decrease of the estimated target volume, the decrease of the dose delivered to the healthy tissue
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 with the radiotherapist, up to 30 minutes
The presence of the markers at the end of the radiotherapy
Visualization of the fiducial markers on CT scan or MRI
Time frame: Clinical examination at the end of the radiotherapy with CT scan or MRI, up to 90 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Société Française d'Endoscopie Digestive