Endoscopic Treatment of Gastroesophageal Reflux Disease

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gastro Esophageal Reflux Disease
• Intervention / Treatment: Other: Endoscopic mucosal band ligation

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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7030
    • St.Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Investigators: Study Director: Gunnar Qvigstad, MD, PhD, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 2, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: 490996/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The plan is to publish all relevant data from this small trial with the detail level permitted by the local approval. Further data sharing will not be planned for.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No