Barrett EsophagusNCT04818476
Outcomes of Endoscopically Resected High-risk Mucosal and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus
An observational study of Barrett Esophagus and Adenocarcinoma Esophagus, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 16 sites in 7 countries.
Trial summary
The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Barrett Esophagus, Adenocarcinoma Esophagus, Submucosal Esophageal Adenocarcinoma
- What is being tested?
- diagnostic endoscopic resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 10 Feb 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent a diagnostic ER for Barrett's related HR T1a or T1b EAC in one of the participating centers, from 1/1/2008 up to the moment of data collection.
Who may be able to join
- Males or females, all ages
- Endoscopic resection of a histologically proven high risk T1a, low risk T1b EAC, or high risk T1b EAC
- Between 1/1/2008 and 1/1/2019
- Endoscopic resection and endoscopic FU (or other treatment after ER) have taken place in the participating center
- No written or oral refusal to use subject's data
Who cannot join
- Objection against participation in this study
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Netherlands7 sites
- Completed
Amsterdam UMC, location VUmc
Amsterdam
- Completed
Catharina Hospital
Eindhoven
- Completed
University Medical Center Groningen
Groningen
- Completed
St. Antonius Hospital
Nieuwegein
- Completed
Erasmus MC - University Medical Center
Rotterdam
- Completed
Haga Medical Center
The Hague
- Completed
Isala Clinics
Zwolle
Germany4 sites, 4 recruiting
- Not yet recruiting
Universitätsklinikum Augsburg
Augsburg
H. Messmann, Helmut.Messmann@uk-augsburg.de
- Not yet recruiting
EVK Duesseldorf
Düsseldorf
Horst Neuhaus
- Not yet recruiting
MRI TUM
Münich
Christoph Schlag
- Not yet recruiting
Barmherzige Brüder Regensburg
Regensburg
Oliver Pech
Australia1 site, 1 recruiting
- Not yet recruiting
Westmead hospital
Sydney
M. Bourke, MD, PhD
Belgium1 site, 1 recruiting
- Recruiting
UZ Gasthuisberg
Leuven
R. Bisschops, MD, PhD
Switzerland1 site, 1 recruiting
- Recruiting
Hirslanden private hospital group
Zurich
S. Seewald
United Kingdom1 site, 1 recruiting
- Not yet recruiting
University College London Hospital
London
R. Haidry, MD, PhD
R. Haidry, MD, PhD
About this study
Official title: Outcomes of Endoscopically Resected High-risk Mucosal Adenocarcinoma and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus: an International Multicenter Retrospective Cohort Study
The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection.
Read the detailed description
The incidence of esophageal adenocarcinoma (EAC) has increased six-fold over the last three decades, making it the most rapidly rising cancer in the Western world. The main histologic risk factor for development of EAC is the presence of Barrett's esophagus (BE). BE can develop from non-dysplastic BE, to low (LGD) and high grade dysplasia (HGD) and, eventually, EAC.
The past two decades minimally invasive endoscopic resection (ER) has replaced surgical esophagectomy as first-choice therapy for the treatment of early neoplastic lesions in Barrett's esophagus. ER provides adequate tissue specimens, allowing for accurate histopathological staging of a lesion, by assessment of invasion depth, differentiation grade, presence of lympho-vascular invasion (LVI), and radicality of the resection. Endoscopic resection thus similarly fulfils a diagnostic and therapeutic role in the management of Barrett's neoplasia.
However, ER offers local treatment and does not include lymph node dissection as is still standard of care during esophagectomy. Therefore, the choice to perform endoscopic follow-up after a radical ER of an early EAC, or to refer a patient for additional surgery, is guided by the assumed risk of lymph node metastasis (LNM).
Data from previous studies show that the risk of LNM is only 1% in patients with low risk mucosal EAC after endoscopic treatment (i.e., infiltration depth limited to the mucosa, G1-G2, without LVI), and <2% in low risk submucosal EAC (i.e., infiltration depth <500μm, good to moderate differentiation grade (G1-G2), without LVI). In high risk submucosal EAC (i.e., infiltration depth ≥500 μm, and/or G3-G4, and/or LVI), the LNM risk is estimated to be much higher (16-44%). Nevertheless, these numbers are mainly based on old surgical series.
Current data is limited in terms of small and heterogeneous patient cohorts, and data for patients with high risk T1a EAC is not available at all. Therefore, we would like to conduct an international multicenter retrospective cohort study in >10 centers to evaluate the safety and efficacy of endoscopic treatment and follow-up of patients with high risk mucosal and submucosal EAC. Our main focus will be the presence of lymph node metastasis and EAC related death.
Aim of this registration study is to collect data of the above-mentioned group of patients and thereby assess lymph node metastasis rate, disease-specific mortality, and overall mortality.
This study will be conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act (WMO), the Medical Treatment Contracts Act (WGBO) and the Dutch Personal Data Protection Act (WBP). The investigators will perform the study in accordance with this protocol and will make sure that participants do not object to using their data. Collection, recording, and reporting of data will be accurate and will ensure the privacy, health, and welfare of research subjects during and after the study.
- Conditions
- Barrett Esophagus, Adenocarcinoma Esophagus, Submucosal Esophageal Adenocarcinoma, High-risk Mucosal Esophageal Adenocarcinoma
- Being tested
- diagnostic endoscopic resection
- Keywords
- Barrett Esophagus, Submucosal esophageal adenocarcinoma, Endoscopic treatment, Endoscopic follow-up, High-risk mucosal esophageal adenocarcinoma
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic endoscopic resectionProcedure or surgery
diagnostic endoscopic resection
| Study group | Role | What they receive |
|---|---|---|
| HR-T1a | Patients who weretreated by radical endoscopic resection for a high-risk mucosal EAC (HR-T1a N0M0) Receives: Procedure: diagnostic endoscopic resection | |
| LR-T1b | Patients who were treated by radical endoscopic resection for a low-risk submucosal EAC (LR-T1b N0M0) Receives: Procedure: diagnostic endoscopic resection | |
| HR-T1b | Patients who were treated by radical endoscopic resection for a high-risk submucosal EAC (HR-T1b N0M0) Receives: Procedure: diagnostic endoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
lymph node metastasis rate
Confirmed by cytology and/or histology by performing FNA during EUS or biopsies
Measured: 10 years
distant metastasis rate
Primary tumor of distant metastasis should be histopathologically evalueted by taking biopsies.
Measured: 10 years
disease-specific mortality
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.
Measured: 10 years
overall mortality
Overall mortality of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start10 Feb 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. J.J.G.H.M. Bergman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- R.E. Pouw, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818476
- Sponsor's protocol ID
- x
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Endoscopically Resected High-risk Mucosal Adenocarcinoma and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus: an International Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04818476
- Acronym / sponsor ID
- x
- Conditions
- Barrett Esophagus, Adenocarcinoma Esophagus, Submucosal Esophageal Adenocarcinoma, High-risk Mucosal Esophageal Adenocarcinoma
- Keywords
- Barrett Esophagus, Submucosal esophageal adenocarcinoma, Endoscopic treatment, Endoscopic follow-up, High-risk mucosal esophageal adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection.
Detailed description
The incidence of esophageal adenocarcinoma (EAC) has increased six-fold over the last three decades, making it the most rapidly rising cancer in the Western world. The main histologic risk factor for development of EAC is the presence of Barrett's esophagus (BE). BE can develop from non-dysplastic BE, to low (LGD) and high grade dysplasia (HGD) and, eventually, EAC.
The past two decades minimally invasive endoscopic resection (ER) has replaced surgical esophagectomy as first-choice therapy for the treatment of early neoplastic lesions in Barrett's esophagus. ER provides adequate tissue specimens, allowing for accurate histopathological staging of a lesion, by assessment of invasion depth, differentiation grade, presence of lympho-vascular invasion (LVI), and radicality of the resection. Endoscopic resection thus similarly fulfils a diagnostic and therapeutic role in the management of Barrett's neoplasia.
However, ER offers local treatment and does not include lymph node dissection as is still standard of care during esophagectomy. Therefore, the choice to perform endoscopic follow-up after a radical ER of an early EAC, or to refer a patient for additional surgery, is guided by the assumed risk of lymph node metastasis (LNM).
Data from previous studies show that the risk of LNM is only 1% in patients with low risk mucosal EAC after endoscopic treatment (i.e., infiltration depth limited to the mucosa, G1-G2, without LVI), and <2% in low risk submucosal EAC (i.e., infiltration depth <500μm, good to moderate differentiation grade (G1-G2), without LVI). In high risk submucosal EAC (i.e., infiltration depth ≥500 μm, and/or G3-G4, and/or LVI), the LNM risk is estimated to be much higher (16-44%). Nevertheless, these numbers are mainly based on old surgical series.
Current data is limited in terms of small and heterogeneous patient cohorts, and data for patients with high risk T1a EAC is not available at all. Therefore, we would like to conduct an international multicenter retrospective cohort study in >10 centers to evaluate the safety and efficacy of endoscopic treatment and follow-up of patients with high risk mucosal and submucosal EAC. Our main focus will be the presence of lymph node metastasis and EAC related death.
Aim of this registration study is to collect data of the above-mentioned group of patients and thereby assess lymph node metastasis rate, disease-specific mortality, and overall mortality.
This study will be conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act (WMO), the Medical Treatment Contracts Act (WGBO) and the Dutch Personal Data Protection Act (WBP). The investigators will perform the study in accordance with this protocol and will make sure that participants do not object to using their data. Collection, recording, and reporting of data will be accurate and will ensure the privacy, health, and welfare of research subjects during and after the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HR-T1a | – | Procedure: diagnostic endoscopic resectionPatients who weretreated by radical endoscopic resection for a high-risk mucosal EAC (HR-T1a N0M0) |
| LR-T1b | – | Procedure: diagnostic endoscopic resectionPatients who were treated by radical endoscopic resection for a low-risk submucosal EAC (LR-T1b N0M0) |
| HR-T1b | – | Procedure: diagnostic endoscopic resectionPatients who were treated by radical endoscopic resection for a high-risk submucosal EAC (HR-T1b N0M0) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent a diagnostic ER for Barrett's related HR T1a or T1b EAC in one of the participating centers, from 1/1/2008 up to the moment of data collection.
Key inclusion criteria (5 listed)
- Males or females, all ages
- Endoscopic resection of a histologically proven high risk T1a, low risk T1b EAC, or high risk T1b EAC
- Between 1/1/2008 and 1/1/2019
- Endoscopic resection and endoscopic FU (or other treatment after ER) have taken place in the participating center
- No written or oral refusal to use subject's data
Key exclusion criteria (1 listed)
- Objection against participation in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic endoscopic resectiondiagnostic endoscopic resection | Procedure or surgery | HR-T1a, HR-T1b, LR-T1b |
Primary outcome
lymph node metastasis rate
Time frame: 10 years
Confirmed by cytology and/or histology by performing FNA during EUS or biopsies
distant metastasis rate
Time frame: 10 years
Primary tumor of distant metastasis should be histopathologically evalueted by taking biopsies.
disease-specific mortality
Time frame: 10 years
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 mortality
Time frame: 10 years
Overall mortality of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R.E. Pouw, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus and Adenocarcinoma Esophagus, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 16 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Netherlands, Germany, Australia, Belgium, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Man Wai Chan, MD ((0)20 4442432, m.w.chan@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lymph node metastasis rate (time frame: 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.