Clinical trial NCT04243668: ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
Official title: ENDOSCOPIC ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) FOR THE TREATMENT OF PROTON PUMP INHIBITOR DEPENDENT GASTRO ESOPHAGEALREFLUX DISEASE: OPEN LABEL SINGLE CENTER OBSERVATIONAL STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: OBJECTIVES To study the safety and efficacy of Endoscopic Anti Reflux Mucosal Ablation (ARMA) procedure for the treatment of proton pump inhibitor (PPI) dependent gastro-esophageal reflux disease (GERD)

DESIGN OF THE Prospective interventional study Sample size: 216

Detailed description: In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.

Submucosal injection and elevation will not be used as a part of ARMA procedure for 10 patients amended protocol version 2.0

Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire.

Inclusion criteria

* Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI
* Patients who are willing to pay the expenses of the ARMA procedure

Exclusion criteria

* Large Hiatal hernia \>3cm
* Gr C/D esophagitis
* Lower esophageal sphincter (LES) pressure\<5 or \>15 mm Hg
* Paraesophageal hernia
* GE flap valve grade IV (Hill's classification)
* Barretts esophagus
* Esophageal dysmotility
* ASA physical status \>II
* Previous esophageal or gastric surgery
* Pregnancy

Patients screening and inclusion:

The study will be conducted over 6-months period. Data of patients presenting with PPI dependent GERD will be recorded and maintained. At initial screening, GERD HRQL and requirement of anti-secretory medicines (detailed drug history) will be assessed along with gastroscopy. All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs. Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines. Basal LES pressure, esophageal motility pattern, 24-h esophageal acid exposure, non acidic bolus reflux, number of reflux episodes, DeMeester score, symptom index and symptom association probability would be assessed.Those patients with pathologic esophageal acid exposure as described previously will be included in the trial. Patients will then be directly assigned by a computer to ARMA procedure. The principle investigator and the study coordinators would be open label to the treatment assignment.

Eligibility criteria: Inclusion Criteria:

* • Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI

  * Patients who are willing to pay the expenses of the ARMA procedure

Exclusion Criteria:

* • Large Hiatal hernia \>3cm

  * Gr C/D esophagitis
  * Lower esophageal sphincter (LES) pressure\<5 or \>15 mm Hg
  * Paraesophageal hernia
  * GE flap valve grade IV (Hill's classification)
  * Barretts esophagus
  * Esophageal dysmotility
  * ASA physical status \>II
  * Previous esophageal or gastric surgery
  * Pregnancy

Primary outcomes:
measure: Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: requirement of PPI at 3, 6 and 12 months
timeFrame: requirement of PPI at 3, 6 and 12 months
measure: Improvement in esophageal acid exposure
timeFrame: 6 months
measure: Improvement in lower esophageal sphincter pressure at 3 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Telangana
Study officials:
affiliation: Chairman
name: Nageshwar Reddy, DNB
role: PRINCIPAL_INVESTIGATOR
References: