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Endoscopic management of patients with high risk T1a and T1b N0M0 esophageal adenocarcinoma: a prospective multicenter registry

Endoscopic management of patients with high risk T1a and T1b N0M0 esophageal adenocarcinoma: a prospective multicenter registry - PREFER study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54809
Enrollment
175
Registered
2017-03-16
Start date
2017-08-22
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer esophageal cancer

Interventions

After endoscopisc treatment: follow-up with frequent gastroscopy, endoscopic ultrasound (EUS), and (PET-)CT-scan. Intervals:year 1 en 2: 3-4-monthly gastroscopy + EUS.&nbsp
year 3 en 4: 6-monthly gastroscopy + EUS.year 5: 1x per year gastroscopy + EUS.(PET-)CT-scan will be performed yearly.

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with high risk mucosal (T1a) or submucosal (T1b) EAC diagnosed in an ER specimen by an expert gastrointestinal (GI) pathologist, without signs of metastases at baseline restaging (N0M0)Signed informed consent.

Exclusion criteria

Exclusion criteria: Prior history of esophageal cancer (invasion of T1sm or deeper or HR T1a). Synchronous esophageal squamous cell carcinomaSuspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the neck, CT-thorax-abdomen or PET-CT during baseline restaging.Tumor-positive deep resection margin (R1) in ER specimenPatients unable to give signed informed consent.

Design outcomes

Primary

MeasureTime frame
5-year disease-specific mortality/survivalOverall survival

Secondary

MeasureTime frame
Lymph node metastasis, confirmed by cytology and and/or histology .Local recurrence eligible for endoscopic therapyLocal recurrence requiring non-endsocopic treatmentDistant metastasis, histopathologically and/or cytologically proven.Quality of life

Countries

Australia, Belgium, Germany, Netherlands, Poland, Switzerland, United Kingdom

Contacts

Public ContactV Bos

Amsterdam UMC

mdl@amsterdamumc.nl020-4441125

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026