A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux

NCT ID: NCT05192538

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2022-05-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic endoloop pre-test treatment

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.

Group Type: EXPERIMENTAL

Endoscopic endoloop pre-test treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing 302 Hospital

OTHER

Sponsor Role: collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role: collaborator

Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Liu, Pro.

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Liu

Role: CONTACT

13911798288@163.com

13911798288

Min Min

Role: CONTACT

minmin823@sina.com

+8613426165452

Facility Contacts

Min Min

Role: primary

minmin823@sina.com

+8613426165452

Other Identifiers

RE-Endoloop

Identifier Type: -

Identifier Source: org_study_id