Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cook Group Incorporated | INDUSTRY |
Not provided
Not provided
Not provided
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:
The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance.
The secondary objectives are to evaluate :
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers | phone contact clinical examination at Day 1, clinical examination at day 30 and at the end of the radiotherapy treatment (day 90) | Day 1, Day 30 and Day 90 |
| The length of the procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Geoffroy VANBIERVLIET, M.D. | Nice University hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulriikka CHAPUT | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39173781 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Prospective study with one single group of 40 patients
Not provided
Not provided
Not provided
Not provided
Duration in minutes of the endoscopic procedure |
| the endoscopic procedure, up to120 minutes |
| The costs (procedure, hospitalization) | sum of all costs : hospital stay, endoscopic procedure, fiducial markers | 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 | Before starting the radiotherapy, the target volume will be estimated with and without fiducial markers, thus estimating the decrease of the estimated target volume and 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 | Visualization of the fiducial markers on CT scan or MRI | Clinical examination at the end of the radiotherapy with CT scan or MRI, up to 90 days |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |