To study the feasibility of the endoscopic guided placement of gold markers in patients with esophageal tumors and to determine the utility of the markers tumor delineation and for positional verification during treatment.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- feasibility and toxictiy of endoscopic placement of goldmarkers in the
oesophageal wall
- utility of the markers for delineation of the tumortargetvolume
- utility of the markers for positional verification and correction during
external radiation (image guided radiotherapy)
Secondary outcome
- analysis of tumor deformation during radiotherapy
- analyses of effect of breathing on tumormobility during radiotherapy
Background summary
Interstitial placement of goldmarkers is a standard procedure to increase
radiation accuracy in the treatment of bladder carcinoma, prostate carcinoma
and pancreas carcinoma at the dept. of Radiotherapy in the AMC.
1.10. STUDY POPULATION
Patients diagnosed with esophageal cancer referred for radiotherapy in the AMC
Inclusion criteria:
Histologically proven esophageal cancer
Referred for radio(chemo)therapy
Exclusion criteria:
Contraindication for an endoscopy of the esophagus
Coagulopathy or platelets < 40.000
Study objective
To study the feasibility of the endoscopic guided placement of gold markers in
patients with esophageal tumors and to determine the utility of the markers
tumor delineation and for positional verification during treatment.
Study design
a prospective feasiblility study to test the feasibility and utility of
endoscopic placement of gold markers in the esophagus.
Intervention
endoscopy of the esophagus with implanation of 3 goldmarkers in the esophageal
wall at the level of the tumor
Study burden and risks
The burden and risks for the patients are estimated al low:
- An endoscopy is a standard procedure without risks and has already been part
of the diagnostic traject for the patient
- Implantation of markers could cause an infection, but the risk is esttimated
low, considering the very low risk of infection during goldmarkers implantation
in prostate, bladder and pancreas cancer (<1%). Short course profylactic
antibiotics will reduce this risk.
- the risk of a bleeding is estimated as low, and if occuring, will be small
condering the small diameter ot het markers and is assumed to be self
limiting. This statement is made based on the broad experience with esophageal
biopsies.
,- gold is non allergic
- goldmarkers that become unstuck will release the body with the defecation
without complaints
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
esophageal cancer
referred for curative radiotherapy
Exclusion criteria
signs of perforation
signs of esophageal infections
coagulopathy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL43179.018.13 |
| OMON | NL-OMON24170 |