Barrett EsophagusESTEBANNCT02583087
ESD for the Treatment of Early Barrett's Neoplasia
An observational study of Barrett Esophagus and Esophageal Neoplasm, run by Hôpital Cochin at 1 site in France.
Trial summary
This study assesses the quality of the resection of early neoplasia arinsing in Barrett's esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Barrett Esophagus, Esophageal Neoplasm
- What is being tested?
- endoscopic submucosal dissection
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2016to Apr 2022
- How long will I take part?
- 3 Years
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 90 years old with a visible lesion suspected of adenocarcinoma arising in a Barrett's esophagus amenable to resection by ESD.
Who may be able to join
- Barrett's esophagus at least C0M2 with histological documentation of intestinal metaplasia
- Visible abnormality of at least 15 mm in size
- Absence of mediastinal or coeliomesenteric enlarged lymph nodes or muscle layer invasion on pretherapeutic EUS
- Absence of mediastinal or coeliomesenteric enlarged lymph nodes or metastases on pretherapeutic CT scan
Who cannot join
- History of esophageal external irradiation
- History of esophagectomy or gastrectomy gastrectomie ou d'oesophagectomie
- Esophageal stricture
- Esophageal varices grade 3 or of any grade with signs of recent bleeding
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cochin Hospital
Paris, 75014
Maximilien Barret, MD, PhD, 0033158414285, maximilien.barret@aphp.fr
About this study
Official title: Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia
This study assesses the quality of the resection of early neoplasia arinsing in Barrett's esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection.
Read the detailed description
Endoscopic submucosal dissection ( ESD) demonstrated great efficacy in the treatment of squamous cell carcinoma of the esophagus. Results for the treatment of esophageal adenocarcinoma arising in Barrett's esophagus are conflicting.
In this multicenter prospective registry among 7 French centers, all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection will be included in the registry. The primary objective is to assess the quality of the resection by ESD of early Barrett's neoplasia (T1A or T1B sm1 or high grade dysplasia). Secondary endpoints are to assess the combined efficacy of a treatment associating ESD and radiofrequency ablation of the remaining Barrett esophagus, and to assess the durability of the results after 3 years.
- Conditions
- Barrett Esophagus, Esophageal Neoplasm
- Being tested
- endoscopic submucosal dissection
- Keywords
- Barrett esophagus, Esophageal adenocarcinoma, Endoscopic submucosal dissection
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic submucosal dissectionProcedure or surgery
Also called endoscopic resection, ESD
Endoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia
R0 resection rate = horizontal margins free from cancer or high grade dysplasia, and vertical margins free from carcinoma.
Measured: 3 months after ESD initial procedure
Secondary outcomes (7)
Rate of en bloc resection via ESD
presence of a single fragment of tissue on histopathological analysis
Measured: 3 months after ESD initial procedure
Rate of histologically complete (R0) resection of esophageal adenocarcinoma
R0 resection rate = horizontal margins free from cancer, and vertical margins free from carcinoma.
Measured: 3 months after ESD initial procedure
Rate of histologically complete (R0) resection of low grade dysplasia
R0 resection rate = horizontal margins free from cancer, high or low grade dysplasia, and vertical margins free from carcinoma.
Measured: 3 months after ESD initial procedure
Curative resection rate of adenocarcinoma
R0 resection of adenocarcinoma, with submucosal invasion <500micrometers, absence of poor differenciation or lymphovascular invasion
Measured: 3 months after ESD initial procedure
Complication rates
early or late complications of ESD
Measured: 3 months
rate of complete remission of adenocarcinoma, high grade dysplasia, low grade dysplasia, and intestinal metaplasia at 1 and 3 years
rate of normal endoscopic and histologic follow-up after ESD
Measured: 3 years after initial procedure
rate of buried glands
Presence of Buried glands on histological analysis of follow-up biopsies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start2 Jan 2016
- Primary completionApr 2019 (estimated)
- Study completionApr 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.
- 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
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hôpital Cochin
- Sponsor type
- University, hospital or other
- Collaborators
- French Society of Digestive Endoscopy, European Georges Pompidou Hospital, Hôpital Edouard Herriot, Hospital Prive Jean Mermoz, University Hospital, Limoges, University Hospital, Bordeaux, Centre Hospitalier Universitaire de Nice
- Responsible party
- Principal investigator, Frederic PRAT, Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583087
- Sponsor's protocol ID
- 20102015
- Acronym
- ESTEBAN
- Status last verified
- Aug 2017
- First submitted
- 20 Oct 2015
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia
- ClinicalTrials.gov ID
- NCT02583087
- Acronym / sponsor ID
- ESTEBAN / 20102015
- Conditions
- Barrett Esophagus, Esophageal Neoplasm
- Keywords
- Barrett esophagus, Esophageal adenocarcinoma, Endoscopic submucosal dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hôpital CochinUniversity, hospital or other
- Collaborators
- French Society of Digestive Endoscopy, European Georges Pompidou Hospital, Hôpital Edouard Herriot, Hospital Prive Jean Mermoz, University Hospital, Limoges, University Hospital, Bordeaux, Centre Hospitalier Universitaire de Nice
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- 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.
This study assesses the quality of the resection of early neoplasia arinsing in Barrett's esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection.
Detailed description
Endoscopic submucosal dissection ( ESD) demonstrated great efficacy in the treatment of squamous cell carcinoma of the esophagus. Results for the treatment of esophageal adenocarcinoma arising in Barrett's esophagus are conflicting.
In this multicenter prospective registry among 7 French centers, all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection will be included in the registry. The primary objective is to assess the quality of the resection by ESD of early Barrett's neoplasia (T1A or T1B sm1 or high grade dysplasia). Secondary endpoints are to assess the combined efficacy of a treatment associating ESD and radiofrequency ablation of the remaining Barrett esophagus, and to assess the durability of the results after 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 90 years old with a visible lesion suspected of adenocarcinoma arising in a Barrett's esophagus amenable to resection by ESD.
Key inclusion criteria (4 listed)
- Barrett's esophagus at least C0M2 with histological documentation of intestinal metaplasia
- Visible abnormality of at least 15 mm in size
- Absence of mediastinal or coeliomesenteric enlarged lymph nodes or muscle layer invasion on pretherapeutic EUS
- Absence of mediastinal or coeliomesenteric enlarged lymph nodes or metastases on pretherapeutic CT scan
Key exclusion criteria (4 listed)
- History of esophageal external irradiation
- History of esophagectomy or gastrectomy gastrectomie ou d'oesophagectomie
- Esophageal stricture
- Esophageal varices grade 3 or of any grade with signs of recent bleeding
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 |
|---|---|---|
| endoscopic submucosal dissectionAlso: endoscopic resection, ESDEndoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc. | Procedure or surgery | – |
Primary outcome
Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia
Time frame: 3 months after ESD initial procedure
R0 resection rate = horizontal margins free from cancer or high grade dysplasia, and vertical margins free from carcinoma.
7 secondary outcomes
Rate of en bloc resection via ESD
Time frame: 3 months after ESD initial procedure
Rate of histologically complete (R0) resection of esophageal adenocarcinoma
Time frame: 3 months after ESD initial procedure
Rate of histologically complete (R0) resection of low grade dysplasia
Time frame: 3 months after ESD initial procedure
Curative resection rate of adenocarcinoma
Time frame: 3 months after ESD initial procedure
Complication rates
Time frame: 3 months
rate of complete remission of adenocarcinoma, high grade dysplasia, low grade dysplasia, and intestinal metaplasia at 1 and 3 years
Time frame: 3 years after initial procedure
rate of buried glands
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus and Esophageal Neoplasm, run by Hôpital Cochin at 1 site in France.
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 4 inclusion and 4 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 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Frederic Prat, MD, PhD (00331 58 41 19 85, frederic.prat@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia (time frame: 3 months after ESD initial procedure). 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 28 Aug 2017.