An interventional study of Endoscopic endoloop pre-test treatment in GERD and Reflux Esophagitis, sponsored by Affiliated Hospital to Academy of Military Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Affiliated Hospital to Academy of Military Medical Sciences · Not applicable, Interventional, and 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.
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Affiliated Hospital to Academy of Military Medical Sciences is the lead sponsor of 65 studies on the registry; 9 are open to participants now.
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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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days
Safety and Tolerability of the procedure
Incidence of Treatment-Emergent Adverse Events
Time frame: 7 days
Safety and Tolerability of the procedure
Incidence of Treatment-Emergent Adverse Events
Time frame: 14 days
Safety and Tolerability of the procedure
Incidence of Treatment-Emergent Adverse Events
Time frame: 1 month
Plan to share: No
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Affiliated Hospital to Academy of Military Medical Sciences