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)

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: Recruiting
• Conditions: Barrett Esophagus Adenocarcinoma
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GENRE Dominique, MD; Phone Number: 33 (0) 4 91 22 37 78; Email: drci.up@ipc.unicancer.fr
• Study Contact Backup: Name: COURNIER Sandra; Phone Number: 33 (0) 4 91 22 37 78; Email: drci.up@ipc.unicancer.fr

Study Locations

• France
  • Marseille, France, 13273
    • Recruiting
    • GENRE
    • Contact: COURNIER Sandra; Phone Number: 33 (0) 4 91 22 37 78; Email: drci.up@ipc.unicancer.fr
    • Principal Investigator: CAILLOL Fabrice, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.	Realization of Ph metric dosage (Gastric Ph monitoring)	36 months

Secondary Outcome Measures

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.	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.	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.	Realization of several follow-up at 36 months.	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.	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.	36 months.
Incidences accumulated of recurrence	Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.	36 months.
Rate of endoscopic complications	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)	Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.	36 months.

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: CAILLOL Fabrice, MD, Institut Paoli-Calmettes

Publications and helpful links

Helpful Links

• Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Precancerous Conditions; Recurrence; Gastroesophageal Reflux; Adenocarcinoma; Barrett Esophagus
• Other Study ID 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