A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux

Affiliated Hospital to Academy of Military Medical Sciences

Status: Unknown

Conditions: Reflux Esophagitis; GERD

Treatments: Device: Endoscopic endoloop pre-test treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05192538

RE-Endoloop

Details and patient eligibility

About

The purpose of this study was to evaluate the safety and efficacy of endoscopic endoloop pre-test for gastroesophageal reflux before anti-reflux surgery or endoscopic treatment. In the study, the investigators used the novel pre-test to narrow the gastric cardia to control symptoms temporarily to decide whether to undergo irreversible surgery or endoscopic treatment.Thirty patients were enrolled and underwent endoscopic endoloop pre-test treatment. The Primary outcome in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. The secondary outcomes included improvement in esophageal 24-hr pH monitoring, improvement in quality of life questionnaires and safety. Patient follow-up assessments were completed at 7 and 14 days post treatment.

Full description

Gastroesophageal reflux disease (GERD) is a neuromuscular disorder with abnormal reflux of gastric contents into the esophagus.The most common symptoms are heartburn, dysphagia, and regurgitation.Due to less invasion, several endoscopic treatments of GERD have been investigated, such as collagen or radio frequency delivery, and antireflux mucosectomy(ARMS).The disadvantages of these treatment included short-term effectiveness, increasing reflux and ulcer, and serious complications. A novel endoscopic endoloop pre-test treatment has been developed, offering a minimally reversible endoscopic treatment to predict whether the symptoms can be alleviated in order to ultimately decide whether to undergo irreversible surgery or endoscopic treatment, which can be performed in an outpatient setting.The aim of this study was to assess the feasibility and safety of the pre-test treatment.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
• Patients considered for non-medical therapy, i.e. unwillingness to take life-long medication in medically-responding disease, suffering from medication side-effects or medically-intractable disease
• Pathological esophageal acid exposure after discontinuation of medical therapy, proven by ambulatory 24-hour pH-monitoring with > 5% of time a pH < 4 and a symptom-association probability > 95%
• written informed consent

Exclusion criteria

• 24 hr acid exposure study showing abnormal esophageal acid exposure <4%
• DeMeester Score <14.7
• hiatal hernia (> 3 cm in length)
• history of antireflux or esophageal/gastric surgery
• severe psychiatric disease
• Barrett's esophagus with dysplasia
• esophageal stenosis/malignancy
• pregnancy or lactation
• history of low therapeutic compliance
• other severe comorbidity (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorder)
• use of anticoagulant or immunosuppressive drugs

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Endoscopic endoloop pre-test treatment

Experimental group

Description:

Endoscopic endoloop pre-test treatment is a less invasive reversible endoscopic treatment to predict whether the gastroesophageal reflux can be alleviated in order to ultimately decide whether to undergo irreversible surgery or endoscopic treatment.

Treatment:

Device: Endoscopic endoloop pre-test treatment