EAISMLP: A New System for GERD Diagnosis and Treatment
Study Details
Study Description
Brief Summary
This is a pilot study measuring a new diagnosis and treatment system "EAISMLP" in adult patients with gastroesophageal reflux disease (GERD).
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Endoscopy-E(+) Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered. |
Procedure: Stretta
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group
Procedure: Laparoscopic Nissen fundoplication
Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group
Drug: PPI
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
Other Names:
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Endoscopy-E(-) Subjects with negative endoscopy finding:NERD. |
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Acid-A(+) Subjects with DeMeester scores>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered. |
Procedure: Stretta
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group
Procedure: Laparoscopic Nissen fundoplication
Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group
Drug: PPI
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
Other Names:
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Acid-A(-) Subjects with DeMeester scores<14.72 |
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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. |
Drug: Probiotic Agent
Probiotic Agent for I(+)G/W;Live Bacillus Licheniformis Cranules 0.5g bid; Bifidbacterium 0.63g bid
Other Names:
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impedance-I(-) Subjects with total reflux number < 80 in 24h pH-impedance monitoring. |
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Reflux-symptom association-S(+) Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered. |
Procedure: Stretta
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group
Drug: PPI
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
Other Names:
Drug: Neuromodulators
Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;
Other Names:
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Reflux-symptom association-S(-) Subjects with negative reflux-symptom association |
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motility-M(+) Subjects with motility disorders according to Chicago v3.0.For subjects of this group, prokinetic motility agents are considered. |
Drug: Prokinetic Motility Agents
Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid
Other Names:
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motility-M(-) Subjects without motility disorders according to Chicago v3.0 |
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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. |
Procedure: Stretta
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group
Procedure: Laparoscopic Nissen fundoplication
Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group
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lower oesophageal sphincter-L(-) Subjects with normal LES pressure and EGJ type I~II |
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psychology-P(+) Subjects with normal psychology condition.For subjects of this group,neuromodulators are considered. |
Drug: Neuromodulators
Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;
Other Names:
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psychology-P(-) Subjects with abnormal psychology condition |
Outcome Measures
Primary Outcome Measures
- Satisfaction of the "EAISMLP system" on GERD symptoms assessed by the HRQL scores. [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]
mean improvement in the GERD-health-related quality of life (HRQL) scores. Scale ranges 0-50 points, the lower score means the better efficacy.
Secondary Outcome Measures
- Satisfaction of the "EAISMLP system" on life quality assessed by the SF-36 scores. [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]
mean improvement in SF-36 scores.Scale ranges 0-100 points, the higher score means the better efficacy.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or Female aged ≥18 years
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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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Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening.
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History of operation in esophagus, stomach or duodenum.
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Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/ pyloric stricture, Primary esophageal spasm, Barrett's esophagus ≥ 3 cm, Zollinger-Ellison syndrome.
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Infectious or inflammatory bowel disease, Severe malabsorption, Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis.
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History of cancer within 5 years, except completely recovered skin cancer ALT or AST ≥ Upper limit of normal range X 3.
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Need antibiotics due to severe infection.
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Pregnant or breast-feeding women.
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Conversation impairment because of alcohol, drug addiction or mental illness, etc.
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Inability to record diary card
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In investigator's judgement
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Capital Medical University
Investigators
- Study Chair: Chuan Zhang, MD, Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- xhnk002