Endoscopic Treatment of Gastroesophageal Reflux Disease

Gastro Esophageal Reflux Disease Clinical Trial

Official title:

Endoscopic Treatment of Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05678491
• Other study ID #: 490996/2022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastro Esophageal Reflux Disease
• Gastroesophageal Reflux

Intervention

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.

Locations

Country	Name	City	State
Norway	St.Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Primary	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	6 months
Primary	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)	3 months
Primary	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)	6 months
Primary	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)	3 months
Primary	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)	6 months
Primary	Adverse events during the study period of 6 months	Adverse events or complications of the treatment will be registered during the study period	6 months
Secondary	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).	3 months
Secondary	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).	6 months
Secondary	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)	3 months
Secondary	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)	6 months