A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2022
CompletedStudy Start
First participant enrolled
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedMarch 16, 2022
March 1, 2022
2 months
November 29, 2021
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (10)
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 Outcomes (7)
Effect on 24-hours esophageal pH-impedance
7 days
Effect on 24-hours esophageal pH-impedance
14 days
Changes in DeMeester score
7 days
Changes in DeMeester score
14 days
Safety and Tolerability of the procedure
7 days
- +2 more secondary outcomes
Study Arms (1)
Endoscopic endoloop pre-test treatment
EXPERIMENTALEndoscopic 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Affiliated Hospital to Academy of Military Medical Scienceslead
- Beijing 302 Hospitalcollaborator
- Beijing Hospitalcollaborator
Study Sites (1)
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100071, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Liu, Pro.
Beijing 302 Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2021
First Posted
January 14, 2022
Study Start
February 10, 2022
Primary Completion
April 1, 2022
Study Completion
May 1, 2022
Last Updated
March 16, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share