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

NCT ID: NCT03057288

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-03
• Study Completion Date: 2021-09-02

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

Detailed Description

• Rational Cancers of the rectum and esophagus affect 15 000 and 4300 people per year in France (TNCD, the national digestive cancer thesaurus). Their prognosis remains bleak, particularly due to late diagnosis, with a 5-year survival rate of 10% for cancers of the esophagus and 55% at 5 years for rectal cancers (TNCD). When diagnosed at an advanced stage (> T2 or N +), treatment with radiotherapy +/- chemotherapy is indicated. The precise definition of macroscopic tumor volume in radiotherapy represents an important difficulty because it is based on endoscopic and imaging data obtained under conditions different from those used in the preparation of radiotherapy treatment. A better definition of the target tumor volume using radiopaque markers known as fiducial markers would be likely to improve the efficacy and tolerance of this treatment, or even to allow additional irradiation that would be targeted more precisely on the tumor.
• Objectives :

The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance.

The secondary objectives are to evaluate :

• 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 primary and secondary • Research methodology It is a prospective multicenter study, 18 centers will participate. Forty patients are to include over a period of 24 months.

Conditions

Esophageal Neoplasm; Rectal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

fiducial markers placement

Prospective study with one arm evaluating the feasibility of fiducial markers placement under echoendoscopic guidance, for patients with esophageal or rectal cancer

Group Type: EXPERIMENTAL

fiducial markers placement

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cook Group Incorporated

INDUSTRY

Sponsor Role: collaborator

Société Française d'Endoscopie Digestive

OTHER

Sponsor Role: lead

Responsible Party

Chaput Ulriikka

Dr Ulriikka CHAPUT MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geoffroy VANBIERVLIET, M.D.

Role: STUDY_CHAIR

Nice University hospital

Locations

Ulriikka CHAPUT

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39173781 (View on PubMed)

Other Identifiers

Etude SFED 115

Identifier Type: -

Identifier Source: org_study_id