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Gastroesophageal reflux disease (GERD) is one of the most common digestive diseases in Western countries, affecting 8% of the population in its typical and frequent form. For typical GERD without alarming symptoms, treatment combines PPI therapy and lifestyle modifications. Patients with an incomplete response to optimized PPI therapy have so-called refractory GERD. Anti-reflux mucosectomy (ARMS) is a recent technique that achieves endoscopic fundoplication by scar-induced tissue retraction using a mucosal ligation system combined with resection, known as the banded ligation system (ARM-b) [6]. Several studies have shown efficacy of approximately 65-70% on symptom resolution and quality of life improvement, including our pilot study of 21 patients, and without serious adverse events.
The purpose of this study is therefore to prospectively evaluate in a randomized blinded comparison to a sham procedure and conventional medical follow-up, the efficacy of anti-reflux mucosectomy (ARMS) in the treatment of refractory GERD.
The hypothesis is that we can achieve a clinical efficacy rate of 65% in the treatment group versus 35% in the control group.
The primary objective is to demonstrate the superiority in terms of clinical efficacy (self-reported symptom-related GERD rate, GERD-SLR) of RAS compared to the sham procedure combined with optimized medical treatment at 1 year. The primary endpoint will be clinical efficacy, defined as a greater than 50% decrease in the number of GERD-associated symptoms, assessed using the GERD-HRQL score.
Secondary objectives will be:
Assessing clinical efficacy at 6 months. Assess the impact on PPI use Assess changes in procedure-induced abnormal esophageal acid exposure by Ph-metry Assess the impact of this technique on patient quality of life; To document the adverse effects of the technique (AGREE, Clavien Dindo and ASGE score) The duration of follow-up will be 1 year, and based on our hypothesis the number of patients to be included will be 130.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A: control group | Sham Comparator |
| |
| group B: ARMS procedure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic mucosal resection | Procedure | The procedure consists of performing endoscopic mucosal resection of the 3/4 of the circumference of the esogastric junction using the Duette system (Cook Endoscopy, USA). The procedure will be performed under general anesthesia in an intubated patient, and realized in ambulatory setting. |
| Measure | Description | Time Frame |
|---|---|---|
| demonstrate superiority of ARMS | the clinical efficacy defined as the decreasing of self-reported related-symptom GERD assessed using the GERD-HRQL score of more than 50% at one year | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the clinical efficacy at 6 months | The clinical efficacy, as defined above, at 6 months | 6 months |
| Evaluating the impact on PPIs use after ARMS and sham procedures, respectively; | The rate (and the date) of complete disruption of PPIs at 1 year if so, or, in case of decreasing the mean daily or weekly dose compared to before the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Michel Gonzalez, MD | Contact | 0491368737 | +33 | jean-michel.gonzalez@ap-hm.fr |
| Amandine Rolland-Brun | Contact | 0491381245 | +33 | amandine.rolland@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HM | Recruiting | Marseille | 13015 | France |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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operating gastroenterologist will be unblind while evaluating gastroenterologist will be blind
|
| sham | Procedure | The procedure consists of performing endoscopic exploration, no mucosal resection |
|
| one year |
| Assessing the changes in abnormal exposure to esophageal acid induced by the procedure | The % time with Ph under 4 on post-operative (3 months) Ph-impedencemetry, compared to pre-operative | 3 months |
| Assessing the changes in abnormal exposure to esophageal acid induced by the procedure | the De Meester score. The interpretation of the score is as follows:
| 3 months |
| Evaluating the impact of this technique on patients' quality of life; | The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 2 months These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale | 2 months |
| Evaluating the impact of this technique on patients' quality of life; | The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 4 months These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale | 4 months |
| Evaluating the impact of this technique on patients' quality of life; | The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 6 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale | 6 months |
| Evaluating the impact of this technique on patients' quality of life; | The quality of life based on Gastrointestinal Quality of Life index (GIQLI) at 1 year. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale | one year |
| Evaluating the impact of this technique on patients' quality of life; | The quality of life based on SF12 scores at 2 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale | 2 months |
| Evaluating the impact of this technique on patients' quality of life; | The quality of life based on SF12 scores at 4 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale | 4 months |
| Evaluating the impact of this technique on patients' quality of life; | The quality of life based on SF12 scores at 6 months. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale | 6 months |
| Evaluating the impact of this technique on patients' quality of life; | The quality of life based on SF12 scores at 1 year. These scores are validated to assess the quality of life specific to digestive diseases. They are free of used and traduced in French. there is no report on a scale | one year |
| Documenting the adverse events of the technique; | The adverse events rate of ARMS procedure, evaluated per-operatively and until 30 post-operative days, their severity assessed using the AGREE classification, and their management | one year |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |