Clinical trial NCT05192538: A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux
Official title: A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux Before Anti-reflux Surgery or Endoscopic Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GERD
Reflux Esophagitis
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
name: Beijing Hospital
First posted: 2022-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
timeFrame: 3 days
measure: Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
timeFrame: 7 days
measure: Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
timeFrame: 14 days
measure: Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
timeFrame: 21 days
measure: Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
timeFrame: 1 month
measure: Improvement in Reflux Symptom Index (RSI) questionnaire scores
timeFrame: 3 days
measure: Improvement in Reflux Symptom Index (RSI) questionnaire scores
timeFrame: 7 days
measure: Improvement in Reflux Symptom Index (RSI) questionnaire scores
timeFrame: 14 days
measure: Improvement in Reflux Symptom Index (RSI) questionnaire scores
timeFrame: 21 days
measure: Improvement in Reflux Symptom Index (RSI) questionnaire scores
timeFrame: 1 month
Secondary outcomes:
measure: Effect on 24-hours esophageal pH-impedance
timeFrame: 7 days
measure: Effect on 24-hours esophageal pH-impedance
timeFrame: 14 days
measure: Changes in DeMeester score
timeFrame: 7 days
measure: Changes in DeMeester score
timeFrame: 14 days
measure: Safety and Tolerability of the procedure
timeFrame: 7 days
measure: Safety and Tolerability of the procedure
timeFrame: 14 days
measure: Safety and Tolerability of the procedure
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Yan Liu, Pro.
role: PRINCIPAL_INVESTIGATOR
References: