No registrations found.
ID
Source
Brief title
Health condition
All patients with a suspicious or known (pre)malignant esophageal squamous cell lesion
Sponsors and support
Intervention
Outcome measures
Primary outcome
The overall accuracy of the JES-classification for predicting the invasion depth of ESCC
Secondary outcome
- Presence and size of avascular areas in the esophageal squamous cell lesions.
- Paris-classification of the esophageal squamous cell lesions.
- Presence of intervascular background coloration.
- Positive/negative pink color sign with Lugol’s iodine staining.
- The predicted invasion depth of the esophageal squamous cell lesions considering the above mentioned parameters.
- Inter- and intraobserver agreement between Western expert endoscopists and non-expert endoscopists, and Japanese endoscopists.
Background summary
The objective of this study is to validate the JES-classification for prediction of invasion depth of superficial squamous cell carcinoma by Western endoscopists in a Western population. This is a multicenter observational study.
Study objective
The JES-classification can be used for predicting invasion depth in esophageal squamous cell carcinoma (ESCC) in Western patients
Study design
After collection of all available endoscopic photos and videos from previously treated patients, the photos and videos will be analyzed by multiple expert endoscopists and non-expert endoscopists.
Intervention
Endoscopic photos and videos of white light endoscopy (WLE), magnification endoscopy, NBI and lugol’s iodine staining from previously treated patients with ESCC will be collected. The photos and videos will be analyzed prospectively by multiple assessors. The ESCC lesions will be scored on their invasion depth by using the microvessel pattern according to the JES-classification.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Western patients with a suspicious or known (pre)malignant esophageal squamous cell lesion
- Photos and videos available using WLE, magnification endoscopy, NBI, and (when available) lugol’s iodine staining.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from any analysis with regard to the prediction of invasion depth:
- No data on histological invasion depth available.
- Patients who underwent esophagectomy with neoadjuvant (chemo)radiation therapy.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8897 |
| Other | MEC-U : W19.234 |