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

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

Sponsors

Lead Sponsor: Institut Paoli-Calmettes

Source Institut Paoli-Calmettes
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.

Overall Status Recruiting
Start Date June 27, 2017
Completion Date June 2022
Primary Completion Date June 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure 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. 36 months
Secondary Outcome
Measure Time Frame
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia. 12 months.
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia. 24 months.
Rate in percentage of long-term recurrence of high grade dysplasia, low grade dysplasia, or Barrett's oesophagus without dysplasia. 36 months.
Evolution of the score of DeMeester of the reflux before and after endoscopic treatment 36 months.
Evolution of the clinical signs of the reflux before and after endoscopic treatment 36 months.
Incidences accumulated of recurrence 36 months.
Rate of endoscopic complications 36 months.
Use of Inhibitor of the pump with proton (PPI) 36 months.
Enrollment 30
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10.

Description: Endoscopic resection treatment

Arm Group Label: Endoscopic resection

Intervention Type: Device

Intervention Name: Endoscopic resection at month 2 and month 4

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.

Arm Group Label: Endoscopic resection

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
CAILLOL Fabrice, MD Principal Investigator Institut Paoli-Calmettes
Overall Contact

Last Name: GENRE Dominique, MD

Phone: 33 (0) 4 91 22 37 78

Email: [email protected]

Location
Facility: Status: Contact: Investigator: GENRE COURNIER Sandra 33 (0) 4 91 22 37 78 [email protected] CAILLOL Fabrice, MD Principal Investigator
Location Countries

France

Verification Date

January 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Endoscopic resection

Type: Other

Acronym B-ARMS
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov