A New System for GERD Diagnosis and Treatment

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A New System for Diagnosis and Treatment of Gastroesophageal Refulx Diseases : Based on Endoscopy, pH Parameter, Impedence Parameter, High Resolution Manometry and Psychology

Conditions
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GERD

Intervention / Treatment
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* Procedure: Stretta
* Procedure: Laparoscopic Nissen fundoplication
* Drug: Probiotic Agent
* Drug: PPI
* Drug: Prokinetic Motility Agents
* Drug: Neuromodulators


Participation Criteria
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Eligibility Criteria
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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: Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening. History of operation in esophagus, stomach or duodenum. Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/ pyloric stricture, Primary esophageal spasm, Barrett's esophagus ≥ 3 cm, Zollinger-Ellison syndrome. Infectious or inflammatory bowel disease, Severe malabsorption, Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis. History of cancer within 5 years, except completely recovered skin cancer ALT or AST ≥ Upper limit of normal range X 3. Need antibiotics due to severe infection. Pregnant or breast-feeding women. Conversation impairment because of alcohol, drug addiction or mental illness, etc. Inability to record diary card In investigator's judgement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopy-E(+)<br>Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered. | Procedure: Stretta<br>* Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group<br>Procedure: Laparoscopic Nissen fundoplication<br>* Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group<br>Drug: PPI<br>* 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<br>* Other names: Pantoprazole;|
| Endoscopy-E(-)<br>Subjects with negative endoscopy finding:NERD. | |
| Acid-A(+)<br>Subjects with DeMeester scores>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered. | Procedure: Stretta<br>* Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group<br>Procedure: Laparoscopic Nissen fundoplication<br>* Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group<br>Drug: PPI<br>* 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<br>* Other names: Pantoprazole;|
| Acid-A(-)<br>Subjects with DeMeester scores<14.72 | |
| impedance-I（+）W/S<br>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<br>* Probiotic Agent for I(+)G/W；Live Bacillus Licheniformis Cranules 0.5g bid； Bifidbacterium 0.63g bid<br>* Other names: Bifidbacterium;|
| impedance-I（-）<br>Subjects with total reflux number < 80 in 24h pH-impedance monitoring. | |
| Reflux-symptom association-S(+)<br>Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered. | Procedure: Stretta<br>* Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group<br>Drug: PPI<br>* 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<br>* Other names: Pantoprazole;Drug: Neuromodulators<br>* Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;<br>* Other names: Citalopram;|
| Reflux-symptom association-S(-)<br>Subjects with negative reflux-symptom association | |
| motility-M(+)<br>Subjects with motility disorders according to Chicago v3.0.For subjects of this group, prokinetic motility agents are considered. | Drug: Prokinetic Motility Agents<br>* Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid<br>* Other names: Domperidone;|
| motility-M(-)<br>Subjects without motility disorders according to Chicago v3.0 | |
| lower oesophageal sphincter-L(+)<br>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<br>* Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group<br>Procedure: Laparoscopic Nissen fundoplication<br>* Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group<br>|
| lower oesophageal sphincter-L(-)<br>Subjects with normal LES pressure and EGJ type I II | |
| psychology-P(+)<br>Subjects with normal psychology condition.For subjects of this group,neuromodulators are considered. | Drug: Neuromodulators<br>* Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;<br>* Other names: Citalopram;|
| psychology-P(-)<br>Subjects with abnormal psychology condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |