Endoscopic Treatment of Gastroesophageal Reflux Disease

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.

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.

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.

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.

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.

GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)

GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)

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).

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).

The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)

The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)

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

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.