Anti-reflux Mucosectomy (ARMS) is a Useful Therapy for Refractory Gastroesophageal Reflux Disease (RGERD)

Not Applicable

• Conditions: Refractory Gastroesophageal Reflux Disease
• Interventions: Procedure: anti-reflux mucosectomy

• Registration Number: NCT03259191
• Lead Sponsor: Ruihua Shi

Brief Summary

Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-08-20
• Study First Submitted: 2017-08-20
• Study First Submitted QC: 2017-08-20
• Last Update Submitted: 2017-08-20
• Study First Posted: 2017-08-23
• Last Update Posted: 2017-08-23
• Primary Completion: 2017-11-20
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Full sufficiency in literacy
2. Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
3. Refractory gastroesophageal reflux disease

Exclusion Criteria

1. Severe heart, lung, and cerebrovascular disease
2. Severe hematopoietic system disease
3. Abnormal blood coagulation function
4. Oropharyngeal abnormalities
5. Severe spine malformation
6. In pregnancy and lactation at present, or plan to become pregnant within 2 years
7. Severe inflammation or huge ulcers in stomach
8. Mental and psychological disorde

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
completely circumferential ARMS	anti-reflux mucosectomy	-
semi-circumferential ARMS	anti-reflux mucosectomy	-

Primary Outcome Measures

Name	Time	Method
Improvement of symptoms	1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months	Improvement of all the symptoms related with RGERD.

Secondary Outcome Measures

Name	Time	Method
Complications of ARMS	1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months	Complications of ARMS,such as esophageal stenosis and dysphagia.

Trial Locations

Locations (1)

Zhongda Hospital Southeast University; 🇨🇳 Nanjing, Jiangsu, China