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Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease

Primary Purpose

Gastroesophageal Reflux Disease

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ARMA (antireflux ablation of the cardiac mucosa)
upper digestive endoscopy
Sponsored by
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring endoscopy, argon gas, antireflux ablation of the cardiac mucosa (ARMA)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age over 18 years.
  2. GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at least have a typical GERD symptom (heartburn or regurgitation).
  3. Total acid exposure time> 6% in pH measurement study without PPI treatment.
  4. Patients who do not want to take PPIs or with chronic consumption, defined as PPI consumption of more than 6 months (consecutive or not) in the last 2 years.
  5. Response to PPI treatment, defined as an increase of> 10 points on the GERD-HRQL questionnaire 15 days after discontinuation of the PPI.
  6. Written informed consent to participate in the study.

Exclusion Criteria:

  1. Patients with sliding hiatal hernia> 2 cm.
  2. Presence of only atypical GERD symptoms.
  3. Age> 75 years.
  4. Grade D peptic esophagitis.
  5. Body mass index> 35 40 kg / m2.
  6. Liver cirrhosis.
  7. Pregnancy.
  8. Incomplete relaxation of the LES in MAR (PIR> 15 mmHg).
  9. Absent peristalsis, defined as 100% failed waves with DCI <100 mmHg * cm * s in MAR.
  10. Esophagogastric surgery or previous endoscopic antireflux technique.
  11. Barrett's esophagus with dysplasia.
  12. Oncological disease.
  13. Esophageal strictures or ulcers.
  14. Severe cardiopulmonary comorbidity (ASA functional class IV-V).
  15. Previously known coagulopathy.
  16. Severe psychiatric disorder
  17. Refusal to participate in the study.

Sites / Locations

  • Hospital de San AgustínRecruiting
  • Hospital Germans Trias I PujolRecruiting
  • Hospital Del MarRecruiting
  • Hospital de CabueñesRecruiting
  • Hospital 12 de OctubreRecruiting
  • Hospital La PazRecruiting
  • Complejo Hospitalario de NavarraRecruiting
  • Hospital La FeRecruiting
  • Hospital Rio Hortega

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

(ARMA) antireflux ablation of the cardiac mucosa

upper digestive endoscopy

Arm Description

The ARMA (Ablation with electrocoagulation current or by argon gas fulguration) technique will be performed in patients assigned to this treatment arm.

Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.

Outcomes

Primary Outcome Measures

To evaluate the clinical efficacy (measured through the GERD-HRQL questionnaire) of the ARMA technique for the endoscopic treatment of PPI-dependent GERD.
GERD-HRQL questionnaire score. Quantitative variable. Clinical success will be defined as a> 50% reduction in symptom score. The scale has 11 items. Each item is scored from 0 to 5, with a higher score indicating a better QOL.

Secondary Outcome Measures

GERD-Q questionnaire score
The GERDQ questionnaire is diagnostic for gastroesophageal reflux disease. Clinical success will be defined as a> 50% reduction in symptom score. The total Total score of 0 to 2 points = 0 % likelihood of GERD; 3 to 7 points = 50 %; 8 to 10 points = 79 %; 1 to 18 points = 89%;
PPI consumption
Ordinal qualitative variable: The patient will indicate if he feels satisfied / neutral / dissatisfied.
pHmetry-impedancemetry
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is acid exposure time.
pHmetry-impedancemetry
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is DeMeester score.
pHmetry-impedancemetry
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is reflux number.
pHmetry-impedancemetry
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is PSPW index.
pHmetry-impedancemetry
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is baseline impedance.
High resolution manometry
This technique measures the pressure of esophageal contractions and with this technique different measurements are obtained such as lower esophageal sphincter resting pressure, integrated relaxation pressure, ICD.

Full Information

First Posted
December 21, 2020
Last Updated
May 29, 2023
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators
Spanish Society of Digestive Endoscopy
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1. Study Identification

Unique Protocol Identification Number
NCT04711655
Brief Title
Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease
Official Title
Double-blind, Placebo-controlled Clinical Trial on the Efficacy of Antireflux Ablation of the Cardiac Mucosa for the Treatment of Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators
Spanish Society of Digestive Endoscopy

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
Gastroesophageal reflux disease (GERD) is defined as the presence of symptoms or complications secondary to the passage of gastric contents into the esophagus, oral cavity or structures of the airway. The prevalence worldwide is between 8-33%. The clinical practice guidelines of the American College of Gastroenterology establish that first-line treatment, in the absence of alarm symptoms, should be carried out empirically. This treatment consists of hygienic-dietary measures and the use of proton pump inhibitors (PPIs) for 8-12 weeks. Despite the proven effectiveness of PPIs, there is 10-40% of patients who do not respond adequately to this treatment. All this has motivated the appearance of endoscopic and surgical techniques that offer an alternative to medical treatment. Among them is the technique of antireflux ablation of the cardiac mucosa (ARMA) in which the resection of the mucosa is replaced by an ablation with electrocoagulation current or by argon gas fulguration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
endoscopy, argon gas, antireflux ablation of the cardiac mucosa (ARMA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
(ARMA) antireflux ablation of the cardiac mucosa
Arm Type
Experimental
Arm Description
The ARMA (Ablation with electrocoagulation current or by argon gas fulguration) technique will be performed in patients assigned to this treatment arm.
Arm Title
upper digestive endoscopy
Arm Type
Placebo Comparator
Arm Description
Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.
Intervention Type
Procedure
Intervention Name(s)
ARMA (antireflux ablation of the cardiac mucosa)
Intervention Description
is an endoscopy in which argon gas ablation of the cardiac mucosa
Intervention Type
Procedure
Intervention Name(s)
upper digestive endoscopy
Intervention Description
Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.
Primary Outcome Measure Information:
Title
To evaluate the clinical efficacy (measured through the GERD-HRQL questionnaire) of the ARMA technique for the endoscopic treatment of PPI-dependent GERD.
Description
GERD-HRQL questionnaire score. Quantitative variable. Clinical success will be defined as a> 50% reduction in symptom score. The scale has 11 items. Each item is scored from 0 to 5, with a higher score indicating a better QOL.
Time Frame
The GERD-HRQL questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).
Secondary Outcome Measure Information:
Title
GERD-Q questionnaire score
Description
The GERDQ questionnaire is diagnostic for gastroesophageal reflux disease. Clinical success will be defined as a> 50% reduction in symptom score. The total Total score of 0 to 2 points = 0 % likelihood of GERD; 3 to 7 points = 50 %; 8 to 10 points = 79 %; 1 to 18 points = 89%;
Time Frame
The GERD-Q questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).
Title
PPI consumption
Description
Ordinal qualitative variable: The patient will indicate if he feels satisfied / neutral / dissatisfied.
Time Frame
It is measured in the different visits after the intervention (month 1, month 3 and month 12)
Title
pHmetry-impedancemetry
Description
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is acid exposure time.
Time Frame
This test will be performed on the patient before the intervention, in month 3 and in month 12
Title
pHmetry-impedancemetry
Description
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is DeMeester score.
Time Frame
This test will be performed on the patient before the intervention, in month 3 and in month 12
Title
pHmetry-impedancemetry
Description
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is reflux number.
Time Frame
This test will be performed on the patient before the intervention, in month 3 and in month 12
Title
pHmetry-impedancemetry
Description
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is PSPW index.
Time Frame
This test will be performed on the patient before the intervention, in month 3 and in month 12
Title
pHmetry-impedancemetry
Description
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is baseline impedance.
Time Frame
This test will be performed on the patient before the intervention, in month 3 and in month 12
Title
High resolution manometry
Description
This technique measures the pressure of esophageal contractions and with this technique different measurements are obtained such as lower esophageal sphincter resting pressure, integrated relaxation pressure, ICD.
Time Frame
This test will be performed on the patient before the intervention, in month 3 and in month 12

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 over 18 years. GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at least have a typical GERD symptom (heartburn or regurgitation). Total acid exposure time> 6% in pH measurement study without PPI treatment. Patients who do not want to take PPIs or with chronic consumption, defined as PPI consumption of more than 6 months (consecutive or not) in the last 2 years. Response to PPI treatment, defined as an increase of> 10 points on the GERD-HRQL questionnaire 15 days after discontinuation of the PPI. Written informed consent to participate in the study. Exclusion Criteria: Patients with sliding hiatal hernia> 2 cm. Presence of only atypical GERD symptoms. Age> 75 years. Grade D peptic esophagitis. Body mass index> 35 40 kg / m2. Liver cirrhosis. Pregnancy. Incomplete relaxation of the LES in MAR (PIR> 15 mmHg). Absent peristalsis, defined as 100% failed waves with DCI <100 mmHg * cm * s in MAR. Esophagogastric surgery or previous endoscopic antireflux technique. Barrett's esophagus with dysplasia. Oncological disease. Esophageal strictures or ulcers. Severe cardiopulmonary comorbidity (ASA functional class IV-V). Previously known coagulopathy. Severe psychiatric disorder Refusal to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique MD Rodríguez de Santiago
Phone
+34913668772
Email
enrodesan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos MD Teruel Sánchez-Vegazo
Phone
+34913668772
Email
cteruelvegazo@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique MD Rodríguez de Santiago
Organizational Affiliation
Servicio de Gastroenterología y Hepatología Hospital Ramón y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de San Agustín
City
Avilés
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel MD Pérez Corte
Phone
+34913668772
Email
enrodesan@gmail.com
Facility Name
Hospital Germans Trias I Pujol
City
Badalona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HUGO MD IKUO UCHIMA KOEVKLIN
Phone
+34913668772
Email
enrodesan@gmail.com
Facility Name
Hospital Del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARCO ANTONIO MD ÁLVAREZ
Phone
+34913668772
Email
enrodesan@gmail.com
Facility Name
Hospital de Cabueñes
City
Gijón
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Covadonga MD García Suárez
Phone
+34913668772
Email
enrodesan@gmail.com
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia MD Arribas
Phone
+34913668772
Email
enrodesan@gmail.com
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro MD De María Pallares
Phone
+34913668772
Email
enrodesan@gmail.com
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo MD Álbeniz Arbizu
Phone
+34913668772
Email
enrodesan@gmail.com
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente MD Lorenzo Zuñiga
Phone
+34913668772
Email
enrodesan@gmail.com
Facility Name
Hospital Rio Hortega
City
Valladolid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henar MD Núñez Rodríguez
Phone
+34913668772
Email
enrodesan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease

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