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

NCT03057288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-12-05

No results posted yet for this study

Summary

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

  • Esophageal Neoplasm
  • Rectal Neoplasms

Interventions

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

Sponsors & Collaborators

  • Cook Group Incorporated

    collaborator INDUSTRY

  • Société Française d'Endoscopie Digestive

    lead OTHER

Principal Investigators

  • Geoffroy VANBIERVLIET, M.D. · Nice University hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-03
Primary Completion
2021-09-02
Completion
2021-09-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03057288 on ClinicalTrials.gov