NCT05192538

A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux

A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux Before Anti-reflux Surgery or Endoscopic Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• GERD
• Reflux Esophagitis

Interventions

Type	Name	Description
DEVICE	Endoscopic endoloop pre-test treatment	A novel endoloop was inserted into the gastric cardia by forceps through the single-channel endoscopy. After adjustment of the endoloop's location and angle, it was anchored onto the edge of the gastric cardia with clip and another 1 or 2 clips were inserted to hold the opposite side of endoloop at about 1/2 circumference. Then the hook was connected with the endoloop, which was tighted by slight pulling together of all the clips.

Timeline

• Start date: 2022-02-10
• Primary completion: 2022-04-01
• Completion: 2022-05-01
• First posted: 2022-01-14
• Last updated: 2022-03-16

Locations

1 site across 1 country: China