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Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma

RECRUITINGN/ASponsored by Amsterdam UMC
Actively Recruiting
PhaseN/A
SponsorAmsterdam UMC
Started2017-07-25
Est. completion2028-07-25
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT03222635

Summary

Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists.
* Signed informed consent.

Exclusion Criteria:

* Prior history of high-risk mucosal or ≥T1sm.
* Synchronous esophageal squamous cell carcinoma.
* Suspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the neck or CT-thorax-abdomen performed six weeks after ER during baseline measurement.
* Tumor-positive deep resection margin (R1) in ER specimen.
* Patients unable to give signed informed consent.

Conditions4

Barrett EsophagusCancerHigh-risk Mucosal Esophageal AdenocarcinomaSubmucosal Esophageal Adenocarcinoma

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