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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC

About this trial

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 criteria

Qualifiers

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

Signed informed consent.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Endoscopic follow-up

Treatment groups

225 Participants
are divided into 1 treatment group

Sponsors and collaborators

Amsterdam UMC

Lead sponsor

Amsterdam UMC, location VUmc

Sponsor institution