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To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARMA Group | Active Comparator | All patients in this group will undergo Anti-reflux mucosal ablation using upper gastrointestinal endoscopy. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view. |
|
| Sham Group | Sham Comparator | UGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARMA | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in esophageal acid exposure | Improvement in esophageal acid exposure in PH impedence monitoring report from baseline. | One Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neeraj Singla, MD | Asian Institute of Gastroenterology, Hyderabad | Principal Investigator |
| Digvijay Chavan | Asian Institute of Gastroenterology, Hyderabad | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian institute of Gastroenterology, hyderabad, India | Hyderabad | Telangana | 500032 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32010745 | Result | 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. | |
| 36109362 |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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A Randomized Sham Control Trial
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A Randomized Sham Control Trial
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| UGI Endoscopy | Procedure | 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. |
|
| 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. |
| 34754155 | Result | 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. |
| D004066 | Digestive System Diseases |
| D004941 | Esophagitis |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |