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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria (all criteria must be fulfilled):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Qvigstad, MD, PhD | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Olavs Hospital | Trondheim | 7030 | Norway |
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.
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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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.
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|
| 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 |
| D004066 | Digestive System Diseases |