Endoscopic Treatment of Gastroesophageal Reflux Disease

Not Applicable

• Conditions: Gastro Esophageal Reflux Disease
• Interventions: Other: Endoscopic mucosal band ligation

• Registration Number: NCT05678491
• Lead Sponsor: St. Olavs Hospital

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.

Study Timeline

• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-10
• Status Verified: 2024-06
• Study Start: 2024-06-01
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic mucosal band ligation	Endoscopic mucosal band ligation	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline esophageal 24 hour pH/impedance at 3 months	3 months	Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Adverse events during the study period of 6 months	6 months	Adverse events or complications of the treatment will be registered during the study period
Change from baseline symptoms of gastroesophageal reflux at 3 months	3 months	GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Change from baseline in use of proton pump inhibitors (PPI) at 3 months	3 months	PPI use (number of days PPI was used during the period 7-14 days before the 3 months visit)
Change from baseline esophageal 24 hour pH/impedance at 6 months	6 months	Esophageal pH/impedance will be measured by a catheter left in place for 24 hours
Change from baseline symptoms of gastroesophageal reflux at 6 months	6 months	GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)
Change from baseline in use of proton pump inhibitors (PPI) at 6 months	6 months	PPI use (number of days PPI was used during the period 7-14 days before the 6 months visit)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Hills flap valve at 3 months	3 months	The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)
Change from baseline in dysphagia at 3 months	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).
Change from baseline in dysphagia at 6 months	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).
Change from baseline in Hills flap valve at 6 months	6 months	The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)

Trial Locations

Locations (1)

St.Olavs Hospital; 🇳🇴 Trondheim, Norway