Endoscopic follow-up for patients with esophageal adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter study aims to evaluate the safety of an endoscopic follow-up strategy for patients who have undergone endoscopic resection for submucosal or high-risk mucosal esophageal adenocarcinoma. Traditionally, the risk of lymph node metastasis has limited the use of endoscopic follow-up, but recent studies suggest that this risk may be lower than previously thought. The study will involve patients diagnosed with specific types of esophageal adenocarcinoma and will assess the feasibility and safety of this less invasive approach. The findings could potentially change the management of these patients, allowing for more organ-preserving treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Westmead hospital
  Sydney, Australia Recruiting
• CUB Hôpital Erasme
  Brussels, Belgium Recruiting
• AZ Maria Middelares Ghent
  Ghent, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• AZ Delta Roeselare
  Roeselare, Belgium Recruiting
• Universitätsklinikum Augsburg
  Augsburg, Germany Recruiting

Study contacts

• Principal investigator: J. J. Bergman, MD, PhD — Amsterdam UMC
• Study coordinator: Vincent Bos, MD
• Email: v.bos@amsterdamumc.nl
• Phone: +31204445500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.