Endoscopic Treatment of Gastroesophageal Reflux Disease
NCT ID: NCT05678491
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
12 participants
INTERVENTIONAL
2025-08-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endoscopic mucosal band ligation
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.
Endoscopic mucosal band ligation
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.
Interventions
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Endoscopic mucosal band ligation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Age \< 18\_years
* Preexisting esophageal stricture
* Gastric stricture \< 2 cm in diameter
* Anti-coagulant medication
* Use of platelet inhibitors other than acetylsalicylic acid
* Manometric indication of motility disorder
* Connective tissue diseases
* BMI \> 35
* Liver cirrhosis
* Coronary heart disease
* Chronic obstructive pulmonary disease
* Other significant comorbidity
* Indication for long-term PPI use other than GERD
18 Years
70 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Gunnar Qvigstad, MD, PhD
Role: STUDY_DIRECTOR
St. Olavs Hospital
Locations
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St.Olavs Hospital
Trondheim, , Norway
Countries
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Other Identifiers
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490996/2022
Identifier Type: -
Identifier Source: org_study_id
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