Endoscopic Treatment of Gastroesophageal Reflux Disease

St. Olavs Hospital

Status: Invitation-only

Conditions: Gastro Esophageal Reflux Disease

Treatments: Other: Endoscopic mucosal band ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT05678491

490996/2022

Details and patient eligibility

About

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. This is a particular problem after surgery to reduce obesity called gastric sleeve resection.

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.

Full description

Gastroesophageal reflux disease (GERD) is very common after gastric sleeve resection 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (all criteria must be fulfilled):

• Previous gastric sleeve resection
• 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 > 5 cm
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Endoscopic mucosal band ligation

Experimental group

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.

Treatment:

Other: Endoscopic mucosal band ligation