RecruitingNot ApplicableNCT03222635
Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma
Endoscopic Management of Patients With High Risk T1a and T1b N0M0 Esophageal Adenocarcinoma: a Prospective Multicenter Registry.
Sponsor
Amsterdam UMC
Enrollment
225 participants
Start Date
Jul 25, 2017
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists.
- Signed informed consent.
Exclusion Criteria5
- 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.
Interventions
PROCEDUREEndoscopic follow-up
Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT03222635
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