Endoscopic follow-up for patients with esophageal adenocarcinoma
Endoscopic Management of Patients With High Risk T1a and T1b N0M0 Esophageal Adenocarcinoma: a Prospective Multicenter Registry.
NA · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT03222635
This study is testing if a less invasive follow-up method using endoscopy is safe for patients who have had surgery for certain types of esophageal adenocarcinoma.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 20 sites (Sydney and 19 other locations) |
| Trial ID | NCT03222635 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with submucosal or high-risk mucosal esophageal adenocarcinoma who have undergone endoscopic resection.
Not a fit: Patients with a prior history of high-risk mucosal or advanced esophageal cancer, or those with signs of metastasis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and less invasive follow-up option for patients with esophageal adenocarcinoma, potentially improving their quality of life.
How similar studies have performed: While traditional approaches have been cautious, recent studies suggest that endoscopic follow-up may be a viable option, indicating a shift in understanding that could support the study's approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Sydney and 19 other locations
- 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)
- EVK Duesseldorf — Düsseldorf, Germany (RECRUITING)
- MRI TUM — Münich, Germany (ACTIVE_NOT_RECRUITING)
- Barmherzige Brüder Regensburg — Regensburg, Germany (RECRUITING)
- Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
- Catharina Hospital — Eindhoven, Netherlands (RECRUITING)
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
- St. Antonius Hospital — Nieuwegein, Netherlands (RECRUITING)
- Radboudumc — Nijmegen, Netherlands (RECRUITING)
- Erasmus MC - University Medical Center — Rotterdam, Netherlands (RECRUITING)
- Haga Medical Center — The Hague, Netherlands (RECRUITING)
- Isala Clinics — Zwolle, Netherlands (RECRUITING)
- Hirslanden private hospital group — Zurich, Switzerland (RECRUITING)
- University College London Hospital — London, United Kingdom (RECRUITING)
- Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: J. J. Bergman, MD, PhD — Amsterdam UMC
- Study coordinator: Vincent Bos, MD
- Email: v.bos@amsterdamumc.nl
- Phone: +31204445500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Submucosal Esophageal Adenocarcinoma, Barrett Esophagus, High-risk Mucosal Esophageal Adenocarcinoma, Barrett's esophagus, Submucosal esophageal adenocarcinoma, Endoscopic treatment, Endoscopic follow-up, High-risk mucosal esophageal adenocarcinoma