Clinical trial · Interventional
Prospective Study Evaluating the Feasibility of Fiducial Markers Placement for Patients With Esophageal or Rectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasm | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fiducial markers placement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- fiducial markers placement
- description
- Prospective study with one arm evaluating the feasibility of fiducial markers placement under echoendoscopic guidance, for patients with esophageal or rectal cancer
- interventionNames
- Device: fiducial markers placement
Primary outcomes (1)
- measure
- Success rate evaluation of the placement of two fiducial markers
- timeFrame
- At the end of the endoscopic procedure, up to 2 hours
- description
- 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.
Secondary outcomes (5)
- measure
- Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \> 18 years * Patients presenting an oesophageal or a rectal tumor passable with a linear echoendoscope * TP\> 60% et Platelets \> 50 000/mm3 * No anticoagulant treatment or antiagregants being taken other than aspirin in the five days preceding the EUS * Patient affiliated to a social security scheme (payee or beneficiary) * Patient who signed a free and informed consent Exclusion Criteria: * Patient \< 18 years * Pregnant Woman * Tumor stenosis impassable by the linear echoendoscope * Patient participation refusal * Patient under legal protection regime (guardianship / curatorship)
References
Publications (1)
- DERIVEDCamus M, Karsenti D, Levy J, Moreno M, Coron E, Esch A, Williet N, Wangermez M, Koch S, Valats JC, Pioche M, Becq A, Vanbiervliet G, Audureau E, Huguet F, Chaput U. Success rate of fiducial marker placement for treatment of esophageal or rectal cancers: a prospective multicenter study (FIDECHO study) (with video). Gastrointest Endosc. 2025 Mar;101(3):570-577. doi: 10.1016/j.gie.2024.08.014. Epub 2024 Aug 20. PMID 39173781