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Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma
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).
Study details:
Traditionally, the risk of lymph node metastasis associated with submucosal EAC was considered too high to offer patients endoscopic follow-up. Only in elderly patients with comorbidity, more often an endoscopic protocol is selected. However, the risk of lymph node metastasis associated with submucosal EAC is mainly based on surgical series.
Recently a number of studies, which included patients treated endoscopically, were published indicating that the risk of lymph node metastasis may be much lower than generally assumed (1-5). Therefore, a less invasive and organ preserving approach may not only be an option in the frail and elderly, but for all patients with submucosal EAC's. Yet, no data exists on the risk of lymph node metastasis in high risk T1a EAC.
The risk is assumed to be lower than for EACs invading into the submucosal layer. However, a recent retrospective analysis from our own research group shows that this risk may be higher than previously assumed (6). In this nationwide retrospective study, we analyzed lymph node metastasis rates and EAC related mortality rates concerning patients with high risk T1a, low risk T1b or high risk T1b EAC who received endoscopic treatment.
The study was performed in 9 Barrett Expert Centers in the Netherlands (2008-2019). 120 patients were included in the analysis, and results showed the highest lymph node metastasis risk in the high risk T1a patient group. Aim of this multicenter study is to prospectively evaluate the safety of endoscopic follow-up in patients treated by endoscopic resection for submucosal (T1bN0M0) and high risk mucosal (T1aN0M0) EAC.
High-resolution upper endoscopy with white-light endoscopy and narrow-band imaging supplemented with an EUS are performed every three months during the first two years after ER. After 1 year, a CT-thorax/abdomen will be performed to check for distant metastasis. During the third and fourth year of follow-up, EUS and upper endoscopy are performed every six months.
From the fifth year on, EUS and upper endoscopy are performed annually.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2017-07-25
Primary completion: 2028-07-25
Study completion finish: 2028-07-25
Study type
TREATMENT
Phase
NA
Trial ID
NCT03222635
Intervention or treatment
PROCEDURE: Endoscopic follow-up
Conditions
- • Submucosal Esophageal Adenocarcinoma
- • Barrett Esophagus
- • High-risk Mucosal Esophageal Adenocarcinoma
Find a site
Closest Location:
Westmead hospital
Research sites nearby
Select from list below to view details:
Westmead hospital
Sydney, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Endoscopic follow-up
| PROCEDURE: Endoscopic follow-up
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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. | 5 years |
| 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). | 5 years |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| Distant metastasis, histologically proven (descriptive statistics in SPSS, number of patients (%)) | Primary tumor of distant metastasis should be histopathologically evalueted by taking biopsies. | 5 years |
| Quality of life during follow-up endoscopies (questionnaires) | Quality of life is assessed by using questionnaires on set time points during the whole study. | 5 years |
Frequently Asked Questions
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