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

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.

Study Overview

• Status: Recruiting
• Conditions: GERD; Reflux Esophagitis
• Intervention / Treatment: Device: Endoscopic endoloop pre-test 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Liu; Phone Number: 13911798288; Email: 13911798288@163.com
• Study Contact Backup: Name: Min Min; Phone Number: +8613426165452; Email: minmin823@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100071
      • Recruiting
      • The Fifth medical center of Chinese PLA General Hospital
      • Contact: Min Min; Phone Number: +8613426165452; Email: minmin823@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	3 days
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	7 days
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	14 days
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	21 days
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores	GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.	1 month
Improvement in Reflux Symptom Index (RSI) questionnaire scores	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	3 days
Improvement in Reflux Symptom Index (RSI) questionnaire scores	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	7 days
Improvement in Reflux Symptom Index (RSI) questionnaire scores	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	14 days
Improvement in Reflux Symptom Index (RSI) questionnaire scores	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	21 days
Improvement in Reflux Symptom Index (RSI) questionnaire scores	RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on 24-hours esophageal pH-impedance	Parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	7 days
Effect on 24-hours esophageal pH-impedance	Parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.	14 days
Changes in DeMeester score	DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.	7 days
Changes in DeMeester score	DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.	14 days
Safety and Tolerability of the procedure	Incidence of Treatment-Emergent Adverse Events	7 days
Safety and Tolerability of the procedure	Incidence of Treatment-Emergent Adverse Events	14 days
Safety and Tolerability of the procedure	Incidence of Treatment-Emergent Adverse Events	1 month

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Collaborators: Beijing 302 Hospital; Beijing Hospital
• Investigators: Principal Investigator: Yan Liu, Pro., Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2022
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (ACTUAL): January 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Esophagitis
• Other Study ID Numbers: RE-Endoloop

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No