A New System for GERD Diagnosis and Treatment

NCT ID: NCT03600974

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-07-01

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.

Conditions

GERD

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Endoscopy-E(+)

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

Stretta

Intervention Type: PROCEDURE

Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

Laparoscopic Nissen fundoplication

Intervention Type: PROCEDURE

Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group

PPI

Intervention Type: DRUG

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

Endoscopy-E(-)

Subjects with negative endoscopy finding:NERD.

No interventions assigned to this group

Acid-A(+)

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

Stretta

Intervention Type: PROCEDURE

Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

Laparoscopic Nissen fundoplication

Intervention Type: PROCEDURE

Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group

PPI

Intervention Type: DRUG

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

Acid-A(-)

Subjects with DeMeester scores\<14.72

No interventions assigned to this group

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.

Probiotic Agent

Intervention Type: DRUG

Probiotic Agent for I(+)G/W；Live Bacillus Licheniformis Cranules 0.5g bid； Bifidbacterium 0.63g bid

impedance-I（-）

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

No interventions assigned to this group

Reflux-symptom association-S(+)

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

Stretta

Intervention Type: PROCEDURE

Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

PPI

Intervention Type: DRUG

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

Neuromodulators

Intervention Type: DRUG

Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;

Reflux-symptom association-S(-)

Subjects with negative reflux-symptom association

No interventions assigned to this group

motility-M(+)

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

Prokinetic Motility Agents

Intervention Type: DRUG

Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid

motility-M(-)

Subjects without motility disorders according to Chicago v3.0

No interventions assigned to this group

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.

Stretta

Intervention Type: PROCEDURE

Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

Laparoscopic Nissen fundoplication

Intervention Type: PROCEDURE

Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group

lower oesophageal sphincter-L(-)

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

No interventions assigned to this group

psychology-P(+)

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

Neuromodulators

Intervention Type: DRUG

Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;

psychology-P(-)

Subjects with abnormal psychology condition

No interventions assigned to this group

Interventions

Stretta

Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

Intervention Type: PROCEDURE

Laparoscopic Nissen fundoplication

Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group

Intervention Type: PROCEDURE

Probiotic Agent

Probiotic Agent for I(+)G/W；Live Bacillus Licheniformis Cranules 0.5g bid； Bifidbacterium 0.63g bid

Intervention Type: 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

Intervention Type: DRUG

Prokinetic Motility Agents

Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid

Intervention Type: DRUG

Neuromodulators

Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;

Intervention Type: DRUG

Other Intervention Names

Live Bacillus Licheniformis Cranules; Bifidbacterium; omeprazole; lansoprazole; Rabeprazole; Esomeprazole; Pantoprazole; Mosapride; Domperidone; Flupentixol and Melitracen; Citalopram

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Guo Zihao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chuan Zhang, MD

Role: STUDY_CHAIR

Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University

Central Contacts

Hao Zi Guo, MD

Role: CONTACT

zihaoguo@139.com

86+15801227696

Other Identifiers

xhnk002

Identifier Type: -

Identifier Source: org_study_id