A New System for GERD Diagnosis and Treatment (EAISMLP)

Capital Medical University

Status: Unknown

Conditions: GERD

Treatments: Drug: Neuromodulators; Drug: Prokinetic Motility Agents; Drug: PPI; Procedure: Stretta; Drug: Probiotic Agent; Procedure: Laparoscopic Nissen fundoplication

Study type: Observational

Funder types: Other

Identifiers

NCT03600974

xhnk002

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 14 patient groups

Endoscopy-E(+)

Description:

Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.

Treatment:

Drug: PPI

Procedure: Stretta

Procedure: Laparoscopic Nissen fundoplication

Endoscopy-E(-)

Description:

Subjects with negative endoscopy finding:NERD.

Acid-A(+)

Description:

Subjects with DeMeester scores\>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.

Treatment:

Drug: PPI

Procedure: Stretta

Procedure: Laparoscopic Nissen fundoplication

Acid-A(-)

Description:

Subjects with DeMeester scores\<14.72

impedance-I（+）W/S

Description:

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.

Treatment:

Drug: Probiotic Agent

impedance-I（-）

Description:

Subjects with total reflux number \< 80 in 24h pH-impedance monitoring.

Reflux-symptom association-S(+)

Description:

Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered.

Treatment:

Drug: PPI

Procedure: Stretta

Drug: Neuromodulators

Reflux-symptom association-S(-)

Description:

Subjects with negative reflux-symptom association

motility-M(+)

Description:

Subjects with motility disorders according to Chicago v3.0.For subjects of this group, prokinetic motility agents are considered.

Treatment:

Drug: Prokinetic Motility Agents

motility-M(-)

Description:

Subjects without motility disorders according to Chicago v3.0

lower oesophageal sphincter-L(+)

Description:

Subjects with abnormal LES pressure or EGJ type III or hiatus hernia.For subjects of this group, Stretta,Laparoscopic Nissen fundoplication is considered.

Treatment:

Procedure: Stretta

Procedure: Laparoscopic Nissen fundoplication

lower oesophageal sphincter-L(-)

Description:

Subjects with normal LES pressure and EGJ type I\~II

psychology-P(+)

Description:

Subjects with normal psychology condition.For subjects of this group,neuromodulators are considered.

Treatment:

Drug: Neuromodulators

psychology-P(-)

Description:

Subjects with abnormal psychology condition