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The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT03193216
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
This study evaluates the addition of an alginate based solution to twice daily proton pump inhibitor therapy (PPI) in patients undergoing ablative therapy for dysplastic Barrett's esophagus. The investigators hypothesize that the addition of this medication will help to achieve complete remission of Barrett's over a shorter period of time.

Condition or disease Intervention/treatment Phase
Barretts Esophagus With Dysplasia Drug: Alginates Phase 2

Detailed Description:

Barrett's esophagus (BE) is a pre-cancerous condition in the esophagus that results from constant acid exposure and is a precursor to esophageal adenocarcinoma (EAC). Surprisingly, EAC rates continue to rise despite efforts aimed at addressing BE. Patients with dysplastic BE are at increased risk for developing EAC and in high grade dysplasia (HGD), this risk can be as high as 6% per year. For these reasons, these patients are candidates for ablation therapy, either with cryotherapy, endoscopic mucosal resection (EMR), and/or radiofrequency ablation (RFA). In patients receiving ablative therapy, 3-5 treatments are typically required before there is resolution of all Barrett's epithelium while patients remain on twice daily proton pump therapy.

A recent case study by the current authors demonstrated initial failed response of BE with HGD to RFA and subsequently cryotherapy. Only after initiation of a liquid alginate solution (Gaviscon Advance - UK formulation) was there a subsequent rapid and complete response to therapy. This case suggests that liquid alginate provided additional esophageal protection allowing mucosal healing and an overall enhanced response to treatment. This finding is mechanistically plausible given existing evidence demonstrating the carcinogenic properties of bile acids and injurious activity of pepsin in non-acid refluxate, and liquid alginate's unique ability to control these components and inhibit acid reflux. The investigators feel further investigation is warranted in studying the role of adjunct liquid alginate solution in patients undergoing treatment for BE.

The ingredient of interest in is alginic acid (alginate), a polysaccharide found in the cell walls of brown algae. Alginates are unique in their ability to form a protective layer above gastric contents upon exposure to gastric acid, thus limiting exposure of esophageal epithelium to gastric acid, bile acid, pepsin, and other parts of the gastric contents. Concurrently, the bicarbonate in alginate-based solutions forms carbon dioxide in the presence of gastric acid, which converts the gel into foam which floats to the surface of the gastric contents. Hence, alginate solutions form "rafts" which provide a physical barrier to acid reflux, as well as a pH-neutral substitute which refluxes preferentially over gastric acid.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot prospective cohort study at a single tertiary center who will be compared to historical controls.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus: A Pilot Study
Actual Study Start Date : August 25, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Alginate group
Patients in this group will be taking the study medication -- alginate solution in addition to standard of care twice daily proton pump inhibitor therapy
Drug: Alginates
Liquid Alginate therapy will be added to twice daily PPI regimen. Patients will be asked to take the alginate solution four times daily (following meals and at bedtime) at 10ml/dose.
Other Name: Gaviscon Advance




Primary Outcome Measures :
  1. Duration of treatment [ Time Frame: 12-18 months ]
    To compare the duration of treatment required to achieve complete endoscopic eradication of BE in patients treated with the combination of PPI and liquid alginate solution vs. those treated with PPI alone


Secondary Outcome Measures :
  1. Number of treatments [ Time Frame: 12-18 months ]
    To compare the number of treatment sessions required to achieve endoscopic eradication of BE in patients treated with the combination of PPI and liquid alginate solution vs. those treated with PPI alone.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • (1) Age 18 (2) Biopsy-proven complicated BE (low/high grade grade dysplasia or IMC, confirmed by our institution's GI pathologist) As part of standard of care, all patients' biopsies will be confirmed with the institutions' GI pathologist and, either with outside biopsies or from biopsies completed at the primary institution.

Exclusion Criteria:

  • 1) Moderate to severe renal impairment, as defined by eGFR< 60 for 2 consecutive readings (2) Lack of capacity for decision-making (3) Allergy to hydroxybenzoates (4) Patients with uncontrolled hypertension or decompensated heart failure (5) Pregnancy- patients of child-bearing potential will be tested. (6) Patients with elevated calcium or potassium on screening laboratory testing (labs completed within the last month)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193216


Contacts
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Contact: Aisha Vanderhorst, BA 843-876-0783 vander@musc.edu
Contact: Puja S Elias, MD, Mph 843-876-0783 eliasps@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Puja S Elias, MD/MPh    843-876-0783    eliasps@musc.edu   
Contact: Aisha Vanderhorsdt, BA         
Sponsors and Collaborators
Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03193216     History of Changes
Other Study ID Numbers: Pro00065861
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of South Carolina:
Barrett's
GERD
reflux
alginate solution
proton pump inhibitor
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action