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NCT03222635Recruiting

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

Official recordSimplified version

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).

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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland, Germany, Australia, Belgium, Netherlands, United Kingdom
Sponsor
Amsterdam UMC(Other)
Protocol no.
NL6116501817
Conditions
Submucosal Esophageal Adenocarcinoma, Barrett Esophagus, High-risk Mucosal Esophageal Adenocarcinoma
Interventions
Procedure

Treatments studied

  • Endoscopic follow-up

Locations · 19

  • Zurich, SwitzerlandHirslanden private hospital groupRecruiting at this site
  • Augsburg, GermanyUniversitätsklinikum AugsburgRecruiting at this site
  • Düsseldorf, GermanyEVK DuesseldorfRecruiting at this site
  • Regensburg, GermanyBarmherzige Brüder RegensburgRecruiting at this site
  • Sydney, AustraliaWestmead hospitalRecruiting at this site
  • Brussels, BelgiumCUB Hôpital ErasmeRecruiting at this site
  • Ghent, BelgiumAZ Maria Middelares GhentRecruiting at this site
  • Leuven, BelgiumUZ LeuvenRecruiting at this site
  • Roeselare, BelgiumAZ Delta RoeselareRecruiting at this site
  • Amsterdam, NetherlandsAmsterdam UMCRecruiting at this site
  • Eindhoven, NetherlandsCatharina HospitalRecruiting at this site
  • Groningen, NetherlandsUniversity Medical Center GroningenRecruiting at this site
  • Nieuwegein, NetherlandsSt. Antonius HospitalRecruiting at this site
  • Nijmegen, NetherlandsRadboudumcRecruiting at this site
  • Rotterdam, NetherlandsErasmus MC - University Medical CenterRecruiting at this site
  • The Hague, NetherlandsHaga Medical CenterRecruiting at this site
  • Zwolle, NetherlandsIsala ClinicsRecruiting at this site
  • London, United KingdomUniversity College London HospitalRecruiting at this site
  • Nottingham, United KingdomNottingham University Hospitals NHS TrustRecruiting at this site

In total, worldwide, 19 of the 20 sites listed in the registry are recruiting; the other one is not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: July 24, 2024).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.