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

NCT03057288 | Completed

• 1 other identifier: Etude SFED 115
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of the endoscopic procedure, up to 2 hours

Secondary Outcomes (5)

• Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers

  Day 1, Day 30 and Day 90

• The length of the procedure

  the endoscopic procedure, up to120 minutes

• The costs (procedure, hospitalization)

  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

  Clinical examination with the radiotherapist, up to 30 minutes

• The presence of the markers at the end of the radiotherapy

  Clinical examination at the end of the radiotherapy with CT scan or MRI, up to 90 days

Study Arms (1)

fiducial markers placement

EXPERIMENTAL

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

Interventions

fiducial markers placement DEVICE

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

fiducial markers placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient \< 18 years
• Pregnant Woman
• Tumor stenosis impassable by the linear echoendoscope
• Patient participation refusal
• Patient under legal protection regime (guardianship / curatorship)

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead
• Cook Group Incorporated: collaborator

Study Sites (1)

Ulriikka CHAPUT

Paris, 75012, France

Location

Related Publications (1)

• Camus 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 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Rectal Diseases

Study Officials

• Geoffroy VANBIERVLIET, M.D.

  Nice University hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ulriikka CHAPUT MD

Model Details: Prospective study with one single group of 40 patients

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 20, 2017
• Study Start: February 3, 2017
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)