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NCT03057288: FIDECHO

Prospective Study Evaluating the Feasibility of Fiducial Markers Placement for Patients With Esophageal or Rectal Cancer

Completed NA Last updated 5 December 2022
What this trial tests

NA trial testing fiducial markers placement in Esophageal Neoplasm in 40 participants. Completed in 2 September 2021.

Timeline
3 February 2017
Primary endpoint
2 September 2021
2 September 2021

Quick facts

Lead sponsorSociété Française d'Endoscopie Digestive
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment40
Start date3 February 2017
Primary completion2 September 2021
Estimated completion2 September 2021
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Société Française d'Endoscopie Digestive — full company profile →

Who can join

18 and older, any sex, with Esophageal Neoplasm or Rectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Success rate of fiducial marker placement for treatment of esophageal or rectal cancers: a prospective multicenter study (FIDECHO study) (with video).
    Camus M, Karsenti D, Levy J, Moreno M, et al · · 2025 · cited 3× · PMID 39173781 · DOI 10.1016/j.gie.2024.08.014

Verify or expand the search:

Other recruiting trials for Esophageal Neoplasm

Currently open trials in the same condition.

Other Société Française d'Endoscopie Digestive trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03057288.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing