Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease

Not Applicable

Recruiting

• Conditions: Gastroesophageal Reflux
• Interventions: Procedure: Hyaluronic acid injection; Procedure: Sodium chloride injection (control group)

• Registration Number: NCT05561179
• Lead Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas

Brief Summary

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.

Detailed Description

GERD is one of the most common digestive pathologies, with a prevalence between 20% and 40% of adults. For the treatment of the disease, proton pump inhibitors (PPIs) have undoubtedly shown effective results; however, in around 30% of patients the complete resolution of symptoms fails.

For the latter, new therapeutic options should be considered. As a modern well-tolerated approach, and for local treatment, hyaluronic acid (HA) appeared to be an option for symptoms relief. HA is a glycosaminoglycan that acts as a natural defense for esophageal mucosa, able to organize the reticular structure as a filter to prevent the diffusion of high molecular substances. In addition, one of its remarkable features is the induction and control of epithelial cells turnover improving the re-epithelization process and the ulcer healing. In addition, hyaluronic acid compounds have shown no migration from the injection site in up to a three-year period.

Based on the above, the investigators aim to assess the effectiveness of hyaluronic acid in gastroesophageal reflux control, to considered it as an alternative effective treatment.

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-29
• Study Start: 2022-09-30
• Study First Posted: 2022-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27
• Primary Completion: 2023-05-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GERD + HA injections	Hyaluronic acid injection	This group is comprised by patients with GERD, assessed previously through 24-Hour pH impedance test and esophageal manometry. The patients are submitted to HA injections at the lower esophageal level.
GERD without HA injections	Sodium chloride injection (control group)	This group is comprised by patients with GERD assessed previously through 24-Hour pH impedance test and esophageal manometry. The patients are submitted to sodium chloride at the lower esophageal level.

Primary Outcome Measures

Name	Time	Method
Assessment of esophageal transit and gastric emptying	Up to 1 month	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.
Change in health-related quality of life	up to 6 months	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.
Acid exposure to the distal esophagus after intervention	Up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Safety of HA injections in GERD	Up to 6 months	Proportion of patients experiencing local adverse events related to the procedure.
Evaluation of lower esophageal sphincter (LES) distensibility and pressure by EndoFLIP	Up to 1 month	Based on pressure and distensibility evaluation of LES by EndoFLIP.; The measure will be made at the beginning, and one month after the procedure.

Trial Locations

Locations (1)

Instituto Ecuatoriano de Enfermedades Digestivas (IECED); 🇪🇨 Guayaquil, Guayas, Ecuador