At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Endoscopic follow-up (procedure)
- How long the study runs
- Study runs about 132 months (dates as stated)
- About the drug or intervention
- Endoscopic follow-up — procedure: Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Amsterdam UMC, follows people who have been diagnosed with certain types of early cancer in the food pipe (oesophagus), called submucosal or high-risk mucosal oesophageal adenocarcinoma. These cancers were found in tissue removed during a procedure called endoscopic resection, where a doctor takes out the tumour using a thin tube passed down the throat. The study aims to keep track of these patients over time, but what the follow-up involves is not stated — ask the trial team.
Who can take part
- People with submucosal or high-risk mucosal oesophageal adenocarcinoma found in tissue removed during an endoscopic resection, confirmed by an expert gut specialist doctor.
- People who have signed a form to say they agree to take part.
Who may not be able to
- People who have had high-risk mucosal cancer or a tumour at stage T1sm or deeper before.
- People who also have a different type of oesophageal cancer called squamous cell carcinoma at the same time.
- People whose scans or ultrasound tests (done six weeks after the endoscopic resection) suggest the cancer has spread to lymph nodes or other parts of the body.
- People whose removed tissue shows cancer cells at the deep cut edge, meaning some cancer may have been left behind.
- People who cannot sign the consent form.
What taking part involves
- • Not stated — ask the trial team.
Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 225
- Started
- 2017-07-25
- Last checked
- 2024-07
Plain English Summary
What is this study?
- • Testing a new treatment for submucosal esophageal adenocarcinoma
- • NA - 225 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with submucosal esophageal adenocarcinoma
Where?
- • London - University College London Hospital
- • Nottingham - Nottingham University Hospitals NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI)...
- ✓Signed agreement to take part.
Who cannot take part
- ✗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...
- ✗Tumor-positive deep resection margin (R1) in ER specimen.
- ✗Patients unable to give signed agreement to take part.
See the full criteria
Where Is This Study? (2 UK sites)
University College London Hospital
London, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
How to Get in Touch
Vincent Bos, MD
Sponsor contactCONTACT