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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
St.Olavs Hospital
Trondheim, Norway
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
Time frame: 3 months
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
Time frame: 6 months
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)
Time frame: 3 months
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)
Time frame: 6 months
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)
Time frame: 3 months
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)
Time frame: 6 months
Adverse events during the study period of 6 months
Adverse events or complications of the treatment will be registered during the study period
Time frame: 6 months
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).
Time frame: 3 months
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).
Time frame: 6 months
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)
Time frame: 3 months
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)
Time frame: 6 months
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