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Validation of the Japanese Esophageal Society classification for prediction of invasion depth of superficial squamous cell carcinoma in a Western population

Validation of the Japanese Esophageal Society classification for prediction of invasion depth of superficial squamous cell carcinoma in a Western population

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26261
Enrollment
94
Registered
2020-09-06
Start date
2020-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All patients with a suspicious or known (pre)malignant esophageal squamous cell lesion

Interventions

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 video

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The overall accuracy of the JES-classification for predicting the invasion depth of ESCC

Secondary

MeasureTime frame
- 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.

Contacts

Public ContactIlse Beaufort

St. Antonius Ziekenhuis

i.n.beaufort-2@umcutrecht.nl088-3206043

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)