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This is a pilot study measuring a new diagnosis and treatment system "EAISMLP" in adult patients with gastroesophageal reflux disease (GERD).
The investigators created a new diagnosis and treatment system for gastroesophageal reflux disease (GERD). The system based on endoscopy, 24h esophageal pH-impedance monitoring, esophagus high resolution manometry and psycological condition.the investigators named it as "EAISMLP" symptom. Each letter in "EAISMLP" is responsible for a typical character and treatment. Subjects will be subtyped according to "EAISMLP" system and underwent treatment, and will be follow up for 6 months and 1 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopy-E(+) | Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered. |
| |
| Endoscopy-E(-) | Subjects with negative endoscopy finding:NERD. | ||
| Acid-A(+) | Subjects with DeMeester scores>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered. |
| |
| Acid-A(-) | Subjects with DeMeester scores<14.72 | ||
| impedance-I（+）W/S | Subjects with total reflux number > 80 in 24h pH-impedance monitoring. W means weakly acid reflux account for above 50% in total reflux number. G means gas reflux account for above 50% in total reflux number.For subjects of this group,probiotic agent is considered. |
| |
| impedance-I（-） |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stretta | Procedure | Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of the "EAISMLP system" on GERD symptoms assessed by the HRQL scores. | mean improvement in the GERD-health-related quality of life (HRQL) scores. Scale ranges 0-50 points, the lower score means the better efficacy. | Change from Baseline HRQL scores at 1 month;Change from Baseline HRQL scores at 2 months;Change from Baseline HRQL scores at 6 months;Change from Baseline HRQL scores at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of the "EAISMLP system" on life quality assessed by the SF-36 scores. | mean improvement in SF-36 scores.Scale ranges 0-100 points, the higher score means the better efficacy. | Change from Baseline SF-36 scores at 1 month;Change from Baseline SF-36 scores at 2 months;Change from Baseline SF-36 scores at 6 months;Change from Baseline SF-36 scores at 1 year |
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Inclusion Criteria:
Male or Female aged ≥18 years
Subjects with refractory reflux symptoms to PPIs standard treatment as follows:
2.1 Ongoing heartburn symptom with or without these GERD-related symptoms : Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating, Satiety, Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia, Odynophagia, Weight loss.
2.2 Ongoing heartburn symptom with or without erosion ≥ grade A according to LA Classification.
Decided to participate and signed on an informed consent form willingly.
Exclusion Criteria:
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Adult subjects with refractory gastroesophageal refulx symptoms.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Zi Guo, MD | Contact | 86+15801227696 | zihaoguo@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuan Zhang, MD | Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University | Study Chair |
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De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be avialable within 1 months of study completion.
Data access requests will be reviewed by an external independant Review Panel. Requestors will be required to sign a Data Access Agreement.
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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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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D064747 | Lansoprazole |
| D064750 | Rabeprazole |
| D064098 | Esomeprazole |
| D000077402 | Pantoprazole |
| C062720 | mosapride |
| D004294 | Domperidone |
| D018377 | Neurotransmitter Agents |
| C000851 | flupentixol, melitracen drug combination |
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Subjects with total reflux number < 80 in 24h pH-impedance monitoring.
| Reflux-symptom association-S(+) | Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered. |
|
| Reflux-symptom association-S(-) | Subjects with negative reflux-symptom association |
| motility-M(+) | Subjects with motility disorders according to Chicago v3.0.For subjects of this group, prokinetic motility agents are considered. |
|
| motility-M(-) | Subjects without motility disorders according to Chicago v3.0 |
| lower oesophageal sphincter-L(+) | Subjects with abnormal LES pressure or EGJ type III or hiatus hernia.For subjects of this group, Stretta,Laparoscopic Nissen fundoplication is considered. |
|
| lower oesophageal sphincter-L(-) | Subjects with normal LES pressure and EGJ type I~II |
| psychology-P(+) | Subjects with normal psychology condition.For subjects of this group,neuromodulators are considered. |
|
| psychology-P(-) | Subjects with abnormal psychology condition |
| Laparoscopic Nissen fundoplication | Procedure | Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group |
|
| Probiotic Agent | Drug | Probiotic Agent for I(+)G/W；Live Bacillus Licheniformis Cranules 0.5g bid； Bifidbacterium 0.63g bid |
|
|
| PPI | Drug | PPIs for A(+),E(+)or S(+) patients: Nexium 20mg Qd/Bid;Lansoprazole 30mg Qd/Bid；omeprazole 10mg-30mg Qd-Bid;Rabeprazole 10mg Qd/Bid;Esomeprazole 20mg Qd/Bid;Pantoprazole 40mg Qd/Bid |
|
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| Prokinetic Motility Agents | Drug | Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid |
|
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| Neuromodulators | Drug | Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid; |
|
|
| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010880 | Piperidines |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D011437 | Propylamines |
| D000588 | Amines |
| D009570 | Nitriles |
| D001572 | Benzofurans |