Gastroesophageal Reflux Clinical Trial
Official title:
Hyaluronic Acid as a Novel Therapeutic Approach for Patients With GERD: a Single-center Study
Gastroesophageal reflux disease (GERD) remains one of the most common pathologies seen among gastroenterologists, surgeons, and primary care physicians. The high prevalence of this condition lead to further investigations in its prevention, diagnosis, and management. For the treatment of this chronic condition, improvement in quality of life and long-term durability should be considered. Nowadays, proton pump inhibitors (PPIs) are considered the mainstay in the treatment of the patients with GERD; however, due to the increasing concern related to its safety in its long-term use and the over prescription of these drugs, new surgical and endoscopic interventions have emerged. A local treatment based on injections of hyaluronic acid, a natural nonimmunogenic mucosal defense, in the lower esophageal mucosa is a tentative treatment option for these patients. Based on this, the investigators pursue to assess the effects of hyaluronic acid in gastroesophageal reflux control.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 30, 2023 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - Adults >18 years old - Patients with diagnosis of GERD (distal esophageal acid exposure time > 6% on 24hour ambulatory pH-impedance monitoring) - Patients with abnormal distal esophageal acid exposure time (4%-6%) on 24-hour ambulatory pH-impedance monitoring - Patients who authorized for endoscopic approach. Exclusion Criteria: - Pregnancy - Any clinical condition which makes endoscopy inviable. - Patients with severe anatomic conditions such as esophageal strictures, Barret´s esophagus, hiatal hernias. - Previous esophageal surgery. - Patients with a history of upper gastrointestinal neoplasia. - Inability to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Ecuador | Instituto Ecuatoriano de Enfermedades Digestivas (IECED) | Guayaquil | Guayas |
Lead Sponsor | Collaborator |
---|---|
Instituto Ecuatoriano de Enfermedades Digestivas |
Ecuador,
Alshehri A, Emil S, Laberge JM, Elkady S, Blumenkrantz M, Mayrand S, Morinville V, Nguyen VH. Lower esophageal sphincter augmentation by endoscopic injection of dextranomer hyaluronic acid copolymer in a porcine gastroesophageal reflux disease model. J Pediatr Surg. 2014 Sep;49(9):1353-9. doi: 10.1016/j.jpedsurg.2014.02.088. — View Citation
Katz PO, Dunbar KB, Schnoll-Sussman FH, Greer KB, Yadlapati R, Spechler SJ. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2022 Jan 1;117(1):27-56. doi: 10.14309/ajg.0000000000001538. — View Citation
Martin K, Emil S, Bernard C, Gaied F, Blumenkrantz M, Laberge JM, Morinville V, Nguyen VH. Dextranomer hyaluronic acid copolymer effects on gastroesophageal junction. J Pediatr Gastroenterol Nutr. 2014 May;58(5):593-7. doi: 10.1097/MPG.0000000000000259. — View Citation
Palmieri B, Merighi A, Corbascio D, Rottigni V, Fistetto G, Esposito A. Fixed combination of hyaluronic acid and chondroitin-sulphate oral formulation in a randomized double blind, placebo controlled study for the treatment of symptoms in patients with non-erosive gastroesophageal reflux. Eur Rev Med Pharmacol Sci. 2013 Dec;17(24):3272-8. — View Citation
Pellegatta G, Mangiavillano B, Semeraro R, Auriemma F, Carlani E, Fugazza A, Vespa E, Repici A. The Effect of Hyaluronic Acid and Chondroitin Sulphate-Based Medical Device Combined with Acid Suppression in the Treatment of Atypical Symptoms in Gastroesophageal Reflux Disease. J Clin Med. 2022 Mar 29;11(7):1890. doi: 10.3390/jcm11071890. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acid exposure to the distal esophagus after intervention | The response to the therapy will be determined by the acid exposure to the distal esophagus, measured through pH monitoring and evaluated by 24-h acid exposure time (AET). AET is defined as the total time for which the pH in the distal esophagus is below 4 divided by the total duration of Multichannel Intraluminal Impedance (MII)-pH monitoring. It is expressed in percentages. AET of more than 4% is considered an abnormal distal esophageal acid exposure.
The patients will be assessed at the beginning, one and six months after the procedure. |
Up to 6 months | |
Primary | Assessment of esophageal transit and gastric emptying | The assessment of gastrointestinal transit through barium x-ray (upper gastrointestinal series) to identify any post-procedural functional motility changes.
The patients will be assessed one month after the procedure. |
Up to 1 month | |
Primary | Change in health-related quality of life | Effect in the Gastroesophageal Reflux Disease Health-related quality of life through the Northwestern Esophageal Quality of Life (NEQOL) scale. NEQOL, a 14-item, single scale measure of Health-related quality of life (HRQOL), allows for rapid assessment in a clinical setting.
The patients will be assessed at the beginning, and six months after the procedure. |
up to 6 months | |
Secondary | Evaluation of lower esophageal sphincter (LES) distensibility and pressure by EndoFLIP | Based on pressure and distensibility evaluation of LES by EndoFLIP.
The measure will be made at the beginning, and one month after the procedure. |
Up to 1 month | |
Secondary | Safety of HA injections in GERD | Proportion of patients experiencing local adverse events related to the procedure. | Up to 6 months |
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