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 (B-ARMS)
Primary Purpose
Barrett Esophagus Adenocarcinoma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10.
Endoscopic resection at month 2 and month 4
Sponsored by
About this trial
This is an interventional treatment trial for Barrett Esophagus Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 and ≤ 75 years,
- High grade dysplasia or superficial Barrett's oesophagus adenocarcinoma diagnosis,
- Written informed consent,
- Affiliation to Social Security System.
Exclusion Criteria:
- 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.
Sites / Locations
- GENRERecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Endoscopic resection
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
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.
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.
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.
Incidences accumulated of recurrence
Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
Rate of endoscopic complications
Realization of several follow-up from Day 1 (post endoscopic resection) to 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03278327
Brief 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
Acronym
B-ARMS
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic resection
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10.
Intervention Description
Endoscopic resection treatment
Intervention Type
Device
Intervention Name(s)
Endoscopic resection at month 2 and month 4
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Realization of Ph metric dosage (Gastric Ph monitoring)
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
Description
Realization of several follow-up at 12 months.
Time Frame
12 months.
Title
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
Description
Realization of several follow-up at 24 months.
Time Frame
24 months.
Title
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
Description
Realization of several follow-up at 36 months.
Time Frame
36 months.
Title
Evolution of the score of DeMeester of the reflux before and after endoscopic treatment
Description
Realization of several follow-up from day 1 (post endoscopic resection) to 36 months.
Time Frame
36 months.
Title
Evolution of the clinical signs of the reflux before and after endoscopic treatment
Description
Realization of several follow-up from day 1 (post endoscopic resection) to 36 months.
Time Frame
36 months.
Title
Incidences accumulated of recurrence
Description
Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
Time Frame
36 months.
Title
Rate of endoscopic complications
Description
Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
Time Frame
36 months.
Title
Use of Inhibitor of the pump with proton (PPI)
Description
Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
Time Frame
36 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 and ≤ 75 years,
High grade dysplasia or superficial Barrett's oesophagus adenocarcinoma diagnosis,
Written informed consent,
Affiliation to Social Security System.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GENRE Dominique, MD
Phone
33 (0) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
COURNIER Sandra
Phone
33 (0) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAILLOL Fabrice, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
GENRE
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COURNIER Sandra
Phone
33 (0) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
CAILLOL Fabrice, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.institutpaolicalmettes.fr
Description
Institut PAOLI-CALMETTES
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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
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