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)

May 5, 2021 updated by: Institut Paoli-Calmettes

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Marseille, France, 13273
        • Recruiting
        • GENRE
        • Contact:
        • Principal Investigator:
          • CAILLOL Fabrice, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Endoscopic resection
Procedure: Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10.
Endoscopic resection treatment
Device: Endoscopic resection at month 2 and month 4

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia.
Time Frame: 12 months.
Realization of several follow-up at 12 months.
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.
Realization of several follow-up at 24 months.
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.
Realization of several follow-up at 36 months.
36 months.
Evolution of the score of DeMeester of the reflux before and after endoscopic treatment
Time Frame: 36 months.
Realization of several follow-up from day 1 (post endoscopic resection) to 36 months.
36 months.
Evolution of the clinical signs of the reflux before and after endoscopic treatment
Time Frame: 36 months.
Realization of several follow-up from day 1 (post endoscopic resection) to 36 months.
36 months.
Incidences accumulated of recurrence
Time Frame: 36 months.
Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
36 months.
Rate of endoscopic complications
Time Frame: 36 months.
Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
36 months.
Use of Inhibitor of the pump with proton (PPI)
Time Frame: 36 months.
Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.
36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Paoli-Calmettes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: CAILLOL Fabrice, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B-ARMS-IPC 2016-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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