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

Ruihua Shi

Status: Unknown

Conditions: Refractory Gastroesophageal Reflux Disease

Treatments: Procedure: anti-reflux mucosectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03259191

GI of Zhongda

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

completely circumferential ARMS

Other group

Treatment:

Procedure: anti-reflux mucosectomy

semi-circumferential ARMS

Other group

Treatment:

Procedure: anti-reflux mucosectomy