Endoscopic Treatment of Gastroesophageal Reflux Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic mucosal band ligation.
- Who it may be relevant to
- Registry conditions: Gastro Esophageal Reflux Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Other 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.
Primary outcome measures
- Change from baseline esophageal 24 hour pH/impedance at 3 months [Time frame: 3 months]
- Change from baseline esophageal 24 hour pH/impedance at 6 months [Time frame: 6 months]
- Change from baseline symptoms of gastroesophageal reflux at 3 months [Time frame: 3 months]
- Change from baseline symptoms of gastroesophageal reflux at 6 months [Time frame: 6 months]
- Change from baseline in use of proton pump inhibitors (PPI) at 3 months [Time frame: 3 months]
- Change from baseline in use of proton pump inhibitors (PPI) at 6 months [Time frame: 6 months]
- Adverse events during the study period of 6 months [Time frame: 6 months]
Secondary outcome measures (4)
- Change from baseline in dysphagia at 3 months [Time frame: 3 months]
- Change from baseline in dysphagia at 6 months [Time frame: 6 months]
- Change from baseline in Hills flap valve at 3 months [Time frame: 3 months]
- Change from baseline in Hills flap valve at 6 months [Time frame: 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- St.Olavs Hospital — Trondheim
Identifiers
NCT: NCT05678491 · 490996/2022