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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 (B-ARMS)

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ClinicalTrials.gov Identifier: NCT03278327
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Barrett Esophagus Adenocarcinoma 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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Incidences accumulated of recurrence [ Time Frame: 36 months. ]
    Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.

  7. Rate of endoscopic complications [ Time Frame: 36 months. ]
    Realization of several follow-up from Day 1 (post endoscopic resection) to 36 months.

  8. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278327


Contacts
Contact: GENRE Dominique, MD 33 (0) 4 91 22 37 78 drci.up@ipc.unicancer.fr
Contact: COURNIER Sandra 33 (0) 4 91 22 37 78 drci.up@ipc.unicancer.fr

Locations
France
GENRE Recruiting
Marseille, France, 13273
Contact: COURNIER Sandra    33 (0) 4 91 22 37 78    drci.up@ipc.unicancer.fr   
Principal Investigator: CAILLOL Fabrice, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: CAILLOL Fabrice, MD Institut Paoli-Calmettes

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03278327     History of Changes
Other Study ID Numbers: B-ARMS-IPC 2016-017
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Adenocarcinoma
Recurrence
Barrett Esophagus
Gastroesophageal Reflux
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders