Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease

NCT05561179 | Unknown

• 1 other identifier: IECED-09282022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux; hyaluronic acid; Esophageal Sphincter

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Evaluation of lower esophageal sphincter (LES) distensibility and pressure by EndoFLIP

  Up to 1 month

• Safety of HA injections in GERD

  Up to 6 months

Study Arms (2)

GERD + HA injections

EXPERIMENTAL

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.

Procedure: Hyaluronic acid injection

GERD without HA injections

PLACEBO COMPARATOR

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.

Procedure: Sodium chloride injection (control group)

Interventions

Hyaluronic acid injection PROCEDURE

Patients with confirmed diagnosis of GERD will be treated with HA injections in the lower esophageal portion. HA + contrast will be injected in the 4 quadrants (4 cc/quadrant). The response to the treatment will be measured by improvement in health-related quality of life index, pH monitoring, and endoluminal functional lumen imaging probe (EndoFLIP). In addition, the patients will be clinically assessed for reflux symptoms.

GERD + HA injections

Sodium chloride injection (control group) PROCEDURE

Patients with a confirmed diagnosis of GERD will be treated with sodium chloride injection in the lower esophageal portion. Sodium chloride + contrast will be injected in the 4 quadrants (4 cc/quadrant). The response to the treatment will be measured by improvement in health-related quality of life index, pH monitoring, and endoluminal functional lumen imaging probe (EndoFLIP). In addition, the patients will be clinically assessed for reflux symptoms.

GERD without HA injections

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Guayaquil, Guayas, 090505, Ecuador

RECRUITING

Related Publications (5)

• 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.

  PMID: 34807007 BACKGROUND

• 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.

  PMID: 24345840 BACKGROUND

• 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.

  PMID: 24379055 BACKGROUND

• 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.

  PMID: 35407497 BACKGROUND

• 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.

  PMID: 25148736 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Hyaluronic Acid; Sodium Chloride; Control Groups

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Carlos Robles-Medranda, MD FASGE

  Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Robles-Medranda, MD FASGE

CONTACT

+59342109180; carlosoakm@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Endoscopy Division

Model Details: A non-blinded, single center, randomized prospective trial

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: September 30, 2022
• Primary Completion: May 30, 2023
• Study Completion: September 30, 2023
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

EC (1)