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).
Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists.
Signed informed consent.
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.
Single group
Endoscopic follow-up
Procedure/SurgeryEndoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds
5-year disease-specific mortality/survival (descriptive statistics in SPSS, percentages, survival analysis)
Disease specific mortality is decribed as mortality directly linked to the esophageal adenocarcinoma (i.e., metastasized EAC, metastasized disease with a simultaneously primary cancer present and it cannot be ruled out (based on histology) that the metastases are related to the other primary cancer, death due to complications of the endoscopic procedure, death due to complications after surgery or CRT, no clear cause of death in patients who have metastases or untreated local recurrence). If patients are diagnosed with distant metastases, and subsequently die of a non-tumor related cause, patients will still be documented as tumor-related death. Will be measured in number of patients and percentages. Survival analysis using Kaplan Meier will be performed.
Overall survival (descriptive statistics in SPSS, percentages, survival analysis)
Overall survival of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).
Lymph node metastasis, confirmed by cytology and/or histology (descriptive statistics in SPSS, number of patients (%))
Confirmed by cytology and/or histology by performing FNA during EUS or biopsies.
Local recurrence eligible for endoscopic therapy (descriptive statistics in SPSS, number of patients (%))
In case a local recurrence is found during FU endoscopy, histopathology have to show if it is recurrent cancer.
Local recurrence requiring surgical therapy (descriptive statistics in SPSS, number of patients (%))
In case a local cancer recurrence is not amendable for endoscopic re-treatment, for example due to extensive disease or fibrosis, a patient will be referred for surgery if possible.
Distant metastasis, histologically proven (descriptive statistics in SPSS, number of patients (%))
Primary tumor of distant metastasis should be histopathologically evalueted by taking biopsies.
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Amsterdam UMC
Lead sponsor
Amsterdam UMC, location VUmc
Sponsor institution
