Clinical trial NCT05678491: Endoscopic Treatment of Gastroesophageal Reflux Disease
Official title: Endoscopic Treatment of Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gastro Esophageal Reflux Disease
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Change from baseline esophageal 24 hour pH/impedance at 3 months
timeFrame: 3 months
measure: Change from baseline esophageal 24 hour pH/impedance at 6 months
timeFrame: 6 months
measure: Change from baseline symptoms of gastroesophageal reflux at 3 months
timeFrame: 3 months
measure: Change from baseline symptoms of gastroesophageal reflux at 6 months
timeFrame: 6 months
measure: Change from baseline in use of proton pump inhibitors (PPI) at 3 months
timeFrame: 3 months
measure: Change from baseline in use of proton pump inhibitors (PPI) at 6 months
timeFrame: 6 months
measure: Adverse events during the study period of 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in dysphagia at 3 months
timeFrame: 3 months
measure: Change from baseline in dysphagia at 6 months
timeFrame: 6 months
measure: Change from baseline in Hills flap valve at 3 months
timeFrame: 3 months
measure: Change from baseline in Hills flap valve at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Gunnar Qvigstad, MD, PhD
role: STUDY_DIRECTOR
References: