Role of ARMA in Selective Subset of Refractory GERD Patients.

GERD Clinical Trial

Official title:

Role of ARMA in Selective Subset of Refractory GERD Patients- A Randomized Sham Control Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899491
• Other study ID #: ARMA
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: Neeraj Singla, MD, DM
• Phone: 8669188042
• Email: docneersk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).

Description:

Patients coming with symptoms of Gastroesophageal reflux disease (GERD) - A digestive disease in which stomach acid or bile irritates the food pipe lining, will be screened for eligibility and informed written consent will be taken. At initial screening, score based on clinical symptoms i.e. Gastroesophageal Reflux Disease- Quality of Life score (GERD HRQL) & Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease Questionnaire (FSSG) score will be completed. All patients will undergo esophagogastroscopy (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract). to look for reflux (the backward flow of stomach acid into the tube that connects your throat to your stomach (esophagus)) related changes in the esophagus.

Esophageal high-resolution Manometry (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done to measure the various parameters which help doctor understand your disease.

24-hr pH impedance (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done after stopping anti-secretory medicines (medicines for the long-term treatment of GERD) for atleast three days to assess for esophageal parameters.

All patients will be divided randomly into two arms, ARMA and sham. Those in the ARMA arm will receive ARMA procedure, while patients in the sham arm will receive only upper gastrointestinal endoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Normal Upper Gastrointestinal endoscopy And

• 24 hour pH Impedance: AET < 6%, More than 80 refluxes

• Patients who are willing to give consent for the procedure

Exclusion Criteria:

• Large Hiatal hernia >3cm

• Lower esophageal sphincter (LES) pressure >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

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• GERD
• Reflux
• Reflux Esophagitis

Intervention

Procedure:
• ARMA
Patients will be instructed to fast for 6 hours pre-ARMA, the Procedure will be performed under propofol-based sedation. Patients will be in the left lateral decubitus position. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view.
• UGI Endoscopy
UGI Endoscopy will be performed under propofol based sedation with scope kept inside for atleast 5 minutes. Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry, reflux questionnaire.

Locations

Country	Name	City	State
India	Asian institute of Gastroenterology, hyderabad, India	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

References & Publications (3)

Chou CK, Chen CC, Chen CC, Wu JF, Liao WC, Chiu HM, Wang HP, Wu MS, Tseng PH. Positive and negative impact of anti-reflux mucosal intervention on gastroesophageal reflux disease. Surg Endosc. 2023 Feb;37(2):1060-1069. doi: 10.1007/s00464-022-09605-z. Epub — View Citation

Inoue H, Tanabe M, de Santiago ER, Abad MRA, Shimamura Y, Fujiyoshi Y, Ueno A, Sumi K, Tomida H, Iwaya Y, Ikeda H, Onimaru M. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot — View Citation

Rodriguez de Santiago E, Albeniz E, Estremera-Arevalo F, Teruel Sanchez-Vegazo C, Lorenzo-Zuniga V. Endoscopic anti-reflux therapy for gastroesophageal reflux disease. World J Gastroenterol. 2021 Oct 21;27(39):6601-6614. doi: 10.3748/wjg.v27.i39.6601. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months.	Improvement in Gastroesophageal reflux disease symptoms by more than 50% from baseline at 3 months which would be assessed based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE.	One Year
Secondary	Improvement in esophageal acid exposure	Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.	One Year