Barrett Esophagus AdenocarcinomaB-ARMSNCT03278327
Impact of an Endoscopic Treatment of the Line Z on the Gastronomic Recurrence and the Gastro- Esophageal Reflux Disease in the Care of the Adenocarcinoma of Barrett's Oesophagus
A study testing Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10. and Endoscopic resection at month 2 and month 4 in people with Barrett Esophagus Adenocarcinoma, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Barrett's oesophagus is a transformation of the esophageal mucous membrane there intestinal metaplasia under the effect of gastro- esophageal reflux disease (GERD). This metaplasia can evolve in low grade dysplasia LGD) , high grade dysplasia (HGD) then invasive adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Barrett Esophagus Adenocarcinoma
- What is being tested?
- Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10. and Endoscopic resection at month 2 and month 4
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2017to Jun 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years,
- High grade dysplasia or superficial Barrett's oesophagus adenocarcinoma diagnosis,
- Written informed consent,
- Affiliation to Social Security System.
Who cannot join
- Hiatal hernia,
- Surgical histories treatment of gastro- esophageal reflux disease,
- Woman pregnant or susceptible to the being,
- Patients deprived of liberty or placed Under the authority of a tutor,
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule,
- Contraindications to the endoscopic procedure.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
GENRE
Marseille, 13273
COURNIER Sandra, 33 (0) 4 91 22 37 78, drci.up@ipc.unicancer.fr
CAILLOL Fabrice, MD
About this study
Barrett's oesophagus is a transformation of the esophageal mucous membrane there intestinal metaplasia under the effect of gastro- esophageal reflux disease (GERD).
This metaplasia can evolve in low grade dysplasia LGD) , high grade dysplasia (HGD) then invasive adenocarcinoma.
Read more
The treatment of the HGD of the Barrett is the endoscopic treatment. It is about a superficial treatment of tumor without ganglionar invasion by definition.
The endoscopic treatment of the Barrett began in the 2000s, and showed its long-term efficiency.
The studied factors of recurrences are the length of the Barrett, the influence of the eradication completes of the Barrett besides the eradication of the dysplasia, as well as the duration of spacing of the procedures. An anatomical zone is particularly delicate to treat. It is about the anatomical junction between the oesophagus and the stomach appointed junction oeso-gastric or cardia or line Z.
This almost virtual zone is the site of most of the recurrence. The first cause of the oesophagus of Barrett and of its transformation in HGD is the reflux.
This reflux can be handled by medicinal action inhibitor of the pump with proton (PPI) or by surgery (hemi-fundo plicator). This reflux is probably the cause of the long-term recurrence found in the literature.
The surgery is a good treatment of the reflux with however unsatisfactory long-term results. On the other hand, the surgery is little used after endoscopic treatment of a HGD not to compromise the surveillance and the detection of a second offense potentially masked in the surgical fundo-plicator. The endoscopic treatment of the expensive ebb because of the based necessary material too on a fundo-plicator is complicated with use in reason also of his cost.
The medical treatment by PPI for life, besides his duration and thus the potential hardness for the patient, presents long-term complications recently described.
Effects on the appearance of gastric precancerous lesion is not certain, but this association with an osteoporosis is more proved true.
The PPI could also be a etiologic factor of chronic renal insufficiency and insanity.
An endoscopic treatment describes by Inoue " Anti-Reflux Mucosectomy " ( ARMS) allows to decrease the gastro- esophageal reflux disease.
This treatment is an equivalent of on treatment of the line Z which would at the same time allow to make sure of the decrease of recurrence on the line Z by complete treatment of this one and to handle the reflux of these patients.
In this experimental series, 10 patients having made this endoscopic treatment were able to stop their treatment by PPI.
The purpose of this study will be to make sure of the efficiency of the endoscopic treatment of the reflux by it on treatment of this line Z while decreasing the frequent recurrences on this line Z.
- Conditions
- Barrett Esophagus Adenocarcinoma
- Being tested
- Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10., Endoscopic resection at month 2 and month 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10.Procedure or surgery
Endoscopic resection treatment
Endoscopic resection at month 2 and month 4Device
System of endoscopic resection of the mucous hurts which can take several forms according to the technical necessities.
The device the most used in this case is the system COOK Medical Duett of Laboratories.
The duration of the treatment will be the same duration as the classic endoscopic resection, that is 30 in 60 minutes.
The resection will be preceded by injection of physiological salt solution tinged with carmine indigo in the sub-mucous membrane.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic resection | Other | Not described Receives: Procedure: Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10.; Device: Endoscopic resection at month 2 and month 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suggest that there are significantly more than 60 % of patients with a relative decrease of at least 50 % between the total percentages of esophageal time crossed in pH4 (Ph metric dosage) before and after endoscopic treatment.
Realization of Ph metric dosage (Gastric Ph monitoring)
Measured: 36 months
Secondary outcomes (8)
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
Realization of several follow-up at 12 months.
Measured: 12 months.
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
Realization of several follow-up at 24 months.
Measured: 24 months.
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
Realization of several follow-up at 36 months.
Measured: 36 months.
Evolution of the score of DeMeester of the reflux before and after endoscopic treatment
Realization of several follow-up from day 1 (post endoscopic resection) to 36 months.
Measured: 36 months.
Evolution of the clinical signs of the reflux before and after endoscopic treatment
Realization of several follow-up from day 1 (post endoscopic resection) to 36 months.
Measured: 36 months.
Incidences accumulated of recurrence
Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
Measured: 36 months.
Rate of endoscopic complications
Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
Measured: 36 months.
Use of Inhibitor of the pump with proton (PPI)
Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
Measured: 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start27 Jun 2017
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett Esophagus AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAILLOL Fabrice, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278327
- Sponsor's protocol ID
- B-ARMS-IPC 2016-017
- Acronym
- B-ARMS
- Status last verified
- May 2021
- First submitted
- 21 Aug 2017
- Last updated
- 6 May 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 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Endoscopic Treatment of the Line Z on the Gastronomic Recurrence and the Gastro- Esophageal Reflux Disease in the Care of the Adenocarcinoma of Barrett's Oesophagus
- ClinicalTrials.gov ID
- NCT03278327
- Acronym / sponsor ID
- B-ARMS / B-ARMS-IPC 2016-017
- Conditions
- Barrett Esophagus Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 11 Sep 2017 (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.
Barrett's oesophagus is a transformation of the esophageal mucous membrane there intestinal metaplasia under the effect of gastro- esophageal reflux disease (GERD).
This metaplasia can evolve in low grade dysplasia LGD) , high grade dysplasia (HGD) then invasive adenocarcinoma.
The treatment of the HGD of the Barrett is the endoscopic treatment. It is about a superficial treatment of tumor without ganglionar invasion by definition.
The endoscopic treatment of the Barrett began in the 2000s, and showed its long-term efficiency.
The studied factors of recurrences are the length of the Barrett, the influence of the eradication completes of the Barrett besides the eradication of the dysplasia, as well as the duration of spacing of the procedures. An anatomical zone is particularly delicate to treat. It is about the anatomical junction between the oesophagus and the stomach appointed junction oeso-gastric or cardia or line Z.
This almost virtual zone is the site of most of the recurrence. The first cause of the oesophagus of Barrett and of its transformation in HGD is the reflux.
This reflux can be handled by medicinal action inhibitor of the pump with proton (PPI) or by surgery (hemi-fundo plicator). This reflux is probably the cause of the long-term recurrence found in the literature.
The surgery is a good treatment of the reflux with however unsatisfactory long-term results. On the other hand, the surgery is little used after endoscopic treatment of a HGD not to compromise the surveillance and the detection of a second offense potentially masked in the surgical fundo-plicator. The endoscopic treatment of the expensive ebb because of the based necessary material too on a fundo-plicator is complicated with use in reason also of his cost.
The medical treatment by PPI for life, besides his duration and thus the potential hardness for the patient, presents long-term complications recently described.
Effects on the appearance of gastric precancerous lesion is not certain, but this association with an osteoporosis is more proved true.
The PPI could also be a etiologic factor of chronic renal insufficiency and insanity.
An endoscopic treatment describes by Inoue " Anti-Reflux Mucosectomy " ( ARMS) allows to decrease the gastro- esophageal reflux disease.
This treatment is an equivalent of on treatment of the line Z which would at the same time allow to make sure of the decrease of recurrence on the line Z by complete treatment of this one and to handle the reflux of these patients.
In this experimental series, 10 patients having made this endoscopic treatment were able to stop their treatment by PPI.
The purpose of this study will be to make sure of the efficiency of the endoscopic treatment of the reflux by it on treatment of this line Z while decreasing the frequent recurrences on this line Z.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic resection | Other | Procedure: Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10., Device: Endoscopic resection at month 2 and month 4 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 75 years,
- High grade dysplasia or superficial Barrett's oesophagus adenocarcinoma diagnosis,
- Written informed consent,
- Affiliation to Social Security System.
Key exclusion criteria (6 listed)
- Hiatal hernia,
- Surgical histories treatment of gastro- esophageal reflux disease,
- Woman pregnant or susceptible to the being,
- Patients deprived of liberty or placed Under the authority of a tutor,
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule,
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 |
|---|---|---|
| Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10.Endoscopic resection treatment | Procedure or surgery | Endoscopic resection |
| Endoscopic resection at month 2 and month 4System of endoscopic resection of the mucous hurts which can take several forms according to the technical necessities. The device the most used in this case is the system COOK Medical Duett of Laboratories. The duration of the treatment will be the same duration as the classic endoscopic resection, that is 30 in 60 minutes. The resection will be preceded by injection of physiological salt solution tinged with carmine indigo in the sub-mucous membrane. | Device | Endoscopic resection |
Primary outcome
Suggest that there are significantly more than 60 % of patients with a relative decrease of at least 50 % between the total percentages of esophageal time crossed in pH4 (Ph metric dosage) before and after endoscopic treatment.
Time frame: 36 months
Realization of Ph metric dosage (Gastric Ph monitoring)
8 secondary outcomes
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
Time frame: 12 months.
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
Time frame: 24 months.
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
Time frame: 36 months.
Evolution of the score of DeMeester of the reflux before and after endoscopic treatment
Time frame: 36 months.
Evolution of the clinical signs of the reflux before and after endoscopic treatment
Time frame: 36 months.
Incidences accumulated of recurrence
Time frame: 36 months.
Rate of endoscopic complications
Time frame: 36 months.
Use of Inhibitor of the pump with proton (PPI)
Time frame: 36 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Institut PAOLI-CALMETTESLink provided by the sponsor.
- 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.
CAILLOL Fabrice, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10. and Endoscopic resection at month 2 and month 4 in people with Barrett Esophagus Adenocarcinoma, run by Institut Paoli-Calmettes 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 6 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 6 May 2021. 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 GENRE Dominique, MD (33 (0) 4 91 22 37 78, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suggest that there are significantly more than 60 % of patients with a relative decrease of at least 50 % between the total percentages of esophageal time crossed in pH4 (Ph metric dosage) before and after endoscopic treatment. (time frame: 36 months). 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 6 May 2021.