A New System for GERD Diagnosis and Treatment (EAISMLP)

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

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

Study Overview

• Status: Unknown
• Conditions: GERD
• Intervention / Treatment: Procedure: Stretta; Procedure: Laparoscopic Nissen fundoplication; Drug: PPI; Drug: Probiotic Agent; Drug: Neuromodulators; Drug: Prokinetic Motility Agents

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Hao Zi Guo, MD; Phone Number: 86+15801227696; Email: zihaoguo@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with refractory gastroesophageal refulx symptoms.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

14

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: Rabeprazole; Esomeprazole; omeprazole; Pantoprazole; lansoprazole
Endoscopy-E(-); Subjects with negative endoscopy finding:NERD.
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: Rabeprazole; Esomeprazole; omeprazole; Pantoprazole; lansoprazole
Acid-A(-); Subjects with DeMeester scores<14.72
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: Live Bacillus Licheniformis Cranules; Bifidbacterium
impedance-I（-）; Subjects with total reflux number < 80 in 24h pH-impedance monitoring.
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: Rabeprazole; Esomeprazole; omeprazole; Pantoprazole; lansoprazole; Drug: Neuromodulators; Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid; Other Names: Citalopram; Flupentixol and Melitracen
Reflux-symptom association-S(-); Subjects with negative reflux-symptom association
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: Mosapride; Domperidone
motility-M(-); Subjects without motility disorders according to Chicago v3.0
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
lower oesophageal sphincter-L(-); Subjects with normal LES pressure and EGJ type I~II
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: Citalopram; Flupentixol and Melitracen
psychology-P(-); Subjects with abnormal psychology condition

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Study Chair: Chuan Zhang, MD, Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 2, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antiemetics; Gastrointestinal Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Serotonin Receptor Agonists; Dopamine Antagonists; Antidepressive Agents, Second-Generation; Anti-Ulcer Agents; Proton Pump Inhibitors; Citalopram; Lansoprazole; Rabeprazole; Omeprazole; Esomeprazole; Pantoprazole; Domperidone; Mosapride; Neurotransmitter Agents
• Other Study ID Numbers: xhnk002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be avialable within 1 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independant Review Panel. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No