search
Back to results

Endoscopic Treatment of Gastroesophageal Reflux Disease

Primary Purpose

Gastro Esophageal Reflux Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Endoscopic mucosal band ligation
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastro Esophageal Reflux Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (both criteria must be fulfilled): GERD. GERD must be diagnosed by either endoscopic esophagitis or esophageal pH measurement with DeMeester score > 14.72 and pH <4 more than 4% of a 24-h period and symptom association probability (SAP) > 95% Subjective insufficient symptom control with PPI therapy once daily or intolerance to PPI or desire to stop PPI treatment and therefore willingness to undergo endoscopic treatment. Exclusion Criteria: Hiatal hernia > 2 cm Age < 18_years Previous esophageal or gastric surgery, Preexisting esophageal stricture Anti-coagulant medication Use of platelet inhibitors other than acetylsalicylic acid Manometric indication of motility disorder Connective tissue diseases BMI > 30 Chronic liver disease Coronary heart disease Chronic obstructive pulmonary disease Other significant comorbidity Indication for long-term PPI use other than GERD

Sites / Locations

  • St.Olavs Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoscopic mucosal band ligation

Arm Description

All 12 patients with GERD will undergo the same procedure. Multiple rubber bands will be used to ligate mucosa in the gastroesophageal junction and cardia in 3/4 of the circumference.

Outcomes

Primary Outcome Measures

Change from baseline esophageal 24 hour pH/impedance at 3 months
Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Change from baseline esophageal 24 hour pH/impedance at 6 months
Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Change from baseline symptoms of gastroesophageal reflux at 3 months
GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Change from baseline symptoms of gastroesophageal reflux at 6 months
GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Change from baseline in use of proton pump inhibitors (PPI) at 3 months
PPI use (number of days PPI was used during the period 7-14 days before the 3 months visit)
Change from baseline in use of proton pump inhibitors (PPI) at 6 months
PPI use (number of days PPI was used during the period 7-14 days before the 6 months visit)
Adverse events during the study period of 6 months
Adverse events or complications of the treatment will be registered during the study period

Secondary Outcome Measures

Change from baseline in dysphagia at 3 months
Dysphagia assessed by Marks score. The minimum value is 0 (no dysphagia) and the maximum value is 6 (can not eat, which is the most severe symptom).
Change from baseline in dysphagia at 6 months
Dysphagia assessed by Marks score. The minimum value is 0 (no dysphagia) and the maximum value is 6 (can not eat, which is the most severe symptom).
Change from baseline in Hills flap valve at 3 months
The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)
Change from baseline in Hills flap valve at 6 months
The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)

Full Information

First Posted
January 2, 2023
Last Updated
July 20, 2023
Sponsor
St. Olavs Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05678491
Brief Title
Endoscopic Treatment of Gastroesophageal Reflux Disease
Official Title
Endoscopic Treatment of Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Gastroesophageal reflux disease (GERD) occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus). This backwash (acid reflux) can irritate the inner lining of the esophagus. The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation. The main questions it aims to answer are: Does the treatment affect gastroesophageal reflux assessed by measuring gastroesophageal reflux Does the treatment affect gastroesophageal reflux symptoms and ability to stop treatment with medication commonly used (proton pump inhibitors) Participants (n=12) will be asked to undergo 24 h reflux examination and report symptoms of GERD. Suitable patients will be offered endoscopic treatment with band ligation of the inner lining of the lower esophagus and upper part of the stomach. The effects will be assessed three and six months after the procedure.
Detailed Description
Gastroesophageal reflux disease (GERD) is common and many patients are dependent on daily use of proton pump inhibitors (PPIs). The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation. Patients (n=12) with GERD satisfying inclusion and exclusion criteria will be invited to participate and the degree of gastroesophageal reflux will be assessed before treatment, and three and six months after the procedure. The results of the trial will be used to plan a larger study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with GERD will be examined at baseline and after three and six months. Variables of GERD will be compared between the three different time points.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic mucosal band ligation
Arm Type
Experimental
Arm Description
All 12 patients with GERD will undergo the same procedure. Multiple rubber bands will be used to ligate mucosa in the gastroesophageal junction and cardia in 3/4 of the circumference.
Intervention Type
Other
Intervention Name(s)
Endoscopic mucosal band ligation
Intervention Description
The mucosa in 3/4 of the circumference of the gastroesophageal junction and cardia will be treated with mucosal band ligation left in place. This will be done during upper endoscopy in sedation. It is the endoscopic procedure that is being investigated.
Primary Outcome Measure Information:
Title
Change from baseline esophageal 24 hour pH/impedance at 3 months
Description
Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Time Frame
3 months
Title
Change from baseline esophageal 24 hour pH/impedance at 6 months
Description
Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Time Frame
6 months
Title
Change from baseline symptoms of gastroesophageal reflux at 3 months
Description
GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Time Frame
3 months
Title
Change from baseline symptoms of gastroesophageal reflux at 6 months
Description
GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Time Frame
6 months
Title
Change from baseline in use of proton pump inhibitors (PPI) at 3 months
Description
PPI use (number of days PPI was used during the period 7-14 days before the 3 months visit)
Time Frame
3 months
Title
Change from baseline in use of proton pump inhibitors (PPI) at 6 months
Description
PPI use (number of days PPI was used during the period 7-14 days before the 6 months visit)
Time Frame
6 months
Title
Adverse events during the study period of 6 months
Description
Adverse events or complications of the treatment will be registered during the study period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in dysphagia at 3 months
Description
Dysphagia assessed by Marks score. The minimum value is 0 (no dysphagia) and the maximum value is 6 (can not eat, which is the most severe symptom).
Time Frame
3 months
Title
Change from baseline in dysphagia at 6 months
Description
Dysphagia assessed by Marks score. The minimum value is 0 (no dysphagia) and the maximum value is 6 (can not eat, which is the most severe symptom).
Time Frame
6 months
Title
Change from baseline in Hills flap valve at 3 months
Description
The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)
Time Frame
3 months
Title
Change from baseline in Hills flap valve at 6 months
Description
The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (both criteria must be fulfilled): GERD. GERD must be diagnosed by either endoscopic esophagitis or esophageal pH measurement with DeMeester score > 14.72 and pH <4 more than 4% of a 24-h period and symptom association probability (SAP) > 95% Subjective insufficient symptom control with PPI therapy once daily or intolerance to PPI or desire to stop PPI treatment and therefore willingness to undergo endoscopic treatment. Exclusion Criteria: Hiatal hernia > 2 cm Age < 18_years Previous esophageal or gastric surgery, Preexisting esophageal stricture Anti-coagulant medication Use of platelet inhibitors other than acetylsalicylic acid Manometric indication of motility disorder Connective tissue diseases BMI > 30 Chronic liver disease Coronary heart disease Chronic obstructive pulmonary disease Other significant comorbidity Indication for long-term PPI use other than GERD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Qvigstad, MD, PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St.Olavs Hospital
City
Trondheim
ZIP/Postal Code
7030
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The plan is to publish all relevant data from this small trial with the detail level permitted by the local approval. Further data sharing will not be planned for.

Learn more about this trial

Endoscopic Treatment of Gastroesophageal Reflux Disease

We'll reach out to this number within 24 hrs