carcinoma of the oesophagus oesophageal cancer
Conditions
Interventions
Two WATS procedures will be performed in addition to the established
bite-on-bite biopsies in patients who are undergoing an EGD in the context of a
clinical response evaluation after nCRT (accordin
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - He/she underwent neoadjuvant chemoradiotherapy according to CROSS and will undergo a clinical response evaluation according to the SANO protocol. - Baseline OGD with biopsies has been performed with documentation of the esophageal sphincter, Z-line (where the squamous epithelium of the esophagus meets the columnar epithelium), esophagogastric junction (upper border of gastric folds) and diaphragmatic impression (all given as the distance from the incisors in cm) as well as photographic re-cordings of suspected lesions for future reference; - CRE-1 endoscopy with bite-on-bite biopsies has been performed after which no histologi-cal evidence of residual tumor has been found; - Age >=18; - Written, voluntary, informed consent; - (And in part 1 of the study: CRE-2 has been performed after which no histological evi-dence of residual tumor has been found)
Exclusion criteria
Exclusion criteria: - Language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent; - Non-traversable tumor for the endoscope (*no-pass*) during the OGD at which WATS should be performed; - Taking anticoagulant drugs (vitamin K antagonist, heparin or heparin derivative substance, or directly acting oral anticoagulant (DOAC)) or having coagulopathy with INR > 2.0 or thrombocytopenia with platelet counts
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: - the histopathological quality of WATS samples; - number and severity of technical malfunctions of the WATS instruments; - duration of performing the WATS procedure; - the correlation between the histopathological result of WATS and bite-on-bite biopsies. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the type, number and severity of complications during the first 30 days after WATS has been performed. | — |
Countries
Netherlands
Outcome results
None listed