A New System for Diagnosis and Treatment of Gastroesophageal Refulx Diseases : Based on Endoscopy, pH Parameter, Impedence Parameter, High Resolution Manometry and Psychology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Satisfaction of the "EAISMLP system" on GERD symptoms assessed by the HRQL scores.
研究概览
简要总结
This is a pilot study measuring a new diagnosis and treatment system "EAISMLP" in adult patients with gastroesophageal reflux disease (GERD).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
Endoscopy-E(+)
Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
干预措施: Stretta (Procedure)
Endoscopy-E(+)
Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
干预措施: Laparoscopic Nissen fundoplication (Procedure)
Endoscopy-E(+)
Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
干预措施: PPI (Drug)
Acid-A(+)
Subjects with DeMeester scores>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
干预措施: Stretta (Procedure)
Acid-A(+)
Subjects with DeMeester scores>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
干预措施: Laparoscopic Nissen fundoplication (Procedure)
Acid-A(+)
Subjects with DeMeester scores>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
干预措施: PPI (Drug)
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.
干预措施: Probiotic Agent (Drug)
Reflux-symptom association-S(+)
Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered.
干预措施: Stretta (Procedure)
Reflux-symptom association-S(+)
Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered.
干预措施: PPI (Drug)
Reflux-symptom association-S(+)
Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered.
干预措施: Neuromodulators (Drug)
motility-M(+)
Subjects with motility disorders according to Chicago v3.0.For subjects of this group, prokinetic motility agents are considered.
干预措施: Prokinetic Motility Agents (Drug)
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.
干预措施: Stretta (Procedure)
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.
干预措施: Laparoscopic Nissen fundoplication (Procedure)
psychology-P(+)
Subjects with normal psychology condition.For subjects of this group,neuromodulators are considered.
干预措施: Neuromodulators (Drug)
结局指标
主要结局
Satisfaction of the "EAISMLP system" on GERD symptoms assessed by the HRQL scores.
时间窗: 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.
次要结局
- 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)
研究者
Guo Zihao
Principal Investigator
Capital Medical University