Clinical trial NCT03600974: A New System for GERD Diagnosis and Treatment
Official title: A New System for Diagnosis and Treatment of Gastroesophageal Refulx Diseases : Based on Endoscopy, pH Parameter, Impedence Parameter, High Resolution Manometry and Psychology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: GERD
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects with refractory gastroesophageal refulx symptoms.

Brief summary: This is a pilot study measuring a new diagnosis and treatment system "EAISMLP" in adult patients with gastroesophageal reflux disease (GERD).

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.

Eligibility criteria: Inclusion Criteria:

1. Male or Female aged ≥18 years
2. 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.
3. Decided to participate and signed on an informed consent form willingly.

Exclusion Criteria:

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

Primary outcomes:
measure: Satisfaction of the "EAISMLP system" on GERD symptoms assessed by the HRQL scores.
timeFrame: 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 outcomes:
measure: Satisfaction of the "EAISMLP system" on life quality assessed by the SF-36 scores.
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University
name: Chuan Zhang, MD
role: STUDY_CHAIR
References: