A New System for GERD Diagnosis and Treatment

• Conditions: GERD
• Interventions: Procedure: Stretta; Drug: Probiotic Agent; Drug: Prokinetic Motility Agents; Procedure: Laparoscopic Nissen fundoplication; Drug: PPI; Drug: Neuromodulators

• Registration Number: NCT03600974
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Status Verified: 2019-02
• Study Start: 2019-02-01
• Last Update Submitted: 2019-02-02
• Last Update Posted: 2019-02-05
• Primary Completion: 2020-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopy-E(+)	Stretta	Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
Endoscopy-E(+)	Laparoscopic Nissen fundoplication	Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
Endoscopy-E(+)	PPI	Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
Acid-A(+)	Stretta	Subjects with DeMeester scores\>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
Acid-A(+)	Laparoscopic Nissen fundoplication	Subjects with DeMeester scores\>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
Acid-A(+)	PPI	Subjects with DeMeester scores\>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
impedance-I（+）W/S	Probiotic Agent	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.
Reflux-symptom association-S(+)	Stretta	Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered.
Reflux-symptom association-S(+)	PPI	Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered.
Reflux-symptom association-S(+)	Neuromodulators	Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered.
motility-M(+)	Prokinetic Motility Agents	Subjects with motility disorders according to Chicago v3.0.For subjects of this group, prokinetic motility agents are considered.
lower oesophageal sphincter-L(+)	Stretta	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(+)	Laparoscopic Nissen fundoplication	Subjects with abnormal LES pressure or EGJ type III or hiatus hernia.For subjects of this group, Stretta,Laparoscopic Nissen fundoplication is considered.
psychology-P(+)	Neuromodulators	Subjects with normal psychology condition.For subjects of this group,neuromodulators are considered.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.