Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05678491

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Gastro Esophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Olavs Hospital

Trondheim, 7030, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline esophageal 24 hour pH/impedance at 3 months

    Time frame: 3 months

    Esophageal pH/impedance will be measured by a catheter left in place for 24 hours

  2. Change from baseline esophageal 24 hour pH/impedance at 6 months

    Time frame: 6 months

    Esophageal pH/impedance will be measured by a catheter left in place for 24 hours

  3. Change from baseline symptoms of gastroesophageal reflux at 3 months

    Time frame: 3 months

    GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)

  4. Change from baseline symptoms of gastroesophageal reflux at 6 months

    Time frame: 6 months

    GERD Q score. Gastroesophageal reflux disease Questionnaire with minimum value 0 (no symptoms) and maximum value 18 (severe symptoms)

  5. Change from baseline in use of proton pump inhibitors (PPI) at 3 months

    Time frame: 3 months

    PPI use (number of days PPI was used during the period 7-14 days before the 3 months visit)

  6. Change from baseline in use of proton pump inhibitors (PPI) at 6 months

    Time frame: 6 months

    PPI use (number of days PPI was used during the period 7-14 days before the 6 months visit)

  7. Adverse events during the study period of 6 months

    Time frame: 6 months

    Adverse events or complications of the treatment will be registered during the study period

Secondary outcomes

  1. Change from baseline in dysphagia at 3 months

    Time frame: 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).

  2. Change from baseline in dysphagia at 6 months

    Time frame: 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).

  3. Change from baseline in Hills flap valve at 3 months

    Time frame: 3 months

    The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)

  4. Change from baseline in Hills flap valve at 6 months

    Time frame: 6 months

    The Hills flap valve assessed during endoscopy. Minimum value is 1 (good function) and the maximum value is 4 (poor function)

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.