Endoscopic Treatment of Gastroesophageal Reflux Disease

NCT05678491 | Enrolling By Invitation

• 1 other identifier: 490996/2022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro Esophageal Reflux Disease

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Change from baseline in dysphagia at 3 months

  3 months

• Change from baseline in dysphagia at 6 months

  6 months

• Change from baseline in Hills flap valve at 3 months

  3 months

• Change from baseline in Hills flap valve at 6 months

  6 months

Study Arms (1)

Endoscopic mucosal band ligation

EXPERIMENTAL

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

Interventions

Endoscopic mucosal band ligation OTHER

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.

Endoscopic mucosal band ligation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

St.Olavs Hospital

Trondheim, 7030, Norway

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Gunnar Qvigstad, MD, PhD

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 10, 2023
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)