Clinical trial NCT05899491: Role of ARMA in Selective Subset of Refractory GERD Patients.
Official title: Role of ARMA in Selective Subset of Refractory GERD Patients- A Randomized Sham Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD
Reflux
Reflux Esophagitis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A Randomized Sham Control Trial
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months.
timeFrame: One Year
Secondary outcomes:
measure: Improvement in esophageal acid exposure
timeFrame: One Year
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian institute of Gastroenterology, hyderabad, India
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology, Hyderabad
name: Neeraj Singla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asian Institute of Gastroenterology, Hyderabad
name: Digvijay Chavan
role: STUDY_CHAIR
References:
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 study. Endosc Int Open. 2020 Feb;8(2):E133-E138. doi: 10.1055/a-1031-9436. Epub 2020 Jan 22.
citation: 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 2022 Sep 15.
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.