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

Recruiting now · Not applicable

Conditions studied: Submucosal Esophageal Adenocarcinoma, Barrett Esophagus, High-risk Mucosal Esophageal Adenocarcinoma

In brief

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).

Key facts

Study ID

NCT03222635

Run by

Amsterdam UMC

People needed

225

Starts

2017-07-25

Expected to finish

2028-07-25

Last updated by the study team

2024-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (enrolling)
• CUB Hôpital Erasme — Brussels, Belgium (enrolling)
• AZ Maria Middelares Ghent — Ghent, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• AZ Delta Roeselare — Roeselare, Belgium (enrolling)
• Universitätsklinikum Augsburg — Augsburg, Germany (enrolling)
• EVK Duesseldorf — Düsseldorf, Germany (enrolling)
• Westmead hospital — Sydney, Australia (enrolling)
• Barmherzige Brüder Regensburg — Regensburg, Germany (enrolling)
• Amsterdam UMC — Amsterdam, Netherlands (enrolling)
• Catharina Hospital — Eindhoven, Netherlands (enrolling)
• University Medical Center Groningen — Groningen, Netherlands (enrolling)
• St. Antonius Hospital — Nieuwegein, Netherlands (enrolling)
• Radboudumc — Nijmegen, Netherlands (enrolling)
• Erasmus MC - University Medical Center — Rotterdam, Netherlands (enrolling)
• Haga Medical Center — The Hague, Netherlands (enrolling)
• Isala Clinics — Zwolle, Netherlands (enrolling)
• Hirslanden private hospital group — Zurich, Switzerland (enrolling)
• University College London Hospital — London, United Kingdom (enrolling)
• MRI TUM — Münich, Germany

Full record on ClinicalTrials.gov

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