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

Sponsor
Amsterdam UMC
Study ID
NCT03222635
Status
Recruiting
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Conditions

  • Barrett Esophagus
  • High-risk Mucosal Esophageal Adenocarcinoma
  • Submucosal Esophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic follow-up — PROCEDURE
    Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds

Study Details

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).

Key Dates

First listed
Jul 19, 2017
Start date
Jul 25, 2017
Status verified
Jul 2024
Primary completion
Jul 25, 2028
Completion
Jul 25, 2028

Study Design

Enrollment
225 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Endoscopic follow-up
    Patients treated with endoscopic resection (ER) for a submucosal or high-risk mucosal esophageal adenocarcinoma without lymphnode- or distant metastases (N0M0) will undergo endoscopic follow-up.

Primary Outcome Measure

5-year disease-specific mortality/survival (descriptive statistics in SPSS, percentages, survival analysis) [ Time Frame: 5 years ]

Central Contacts

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