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A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux

Primary Purpose

GERD, Reflux Esophagitis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic endoloop pre-test treatment
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GERD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Fifth Medical Center of Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoscopic endoloop pre-test treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Safety and Tolerability of the procedure
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability of the procedure
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability of the procedure
Incidence of Treatment-Emergent Adverse Events

Full Information

First Posted
November 29, 2021
Last Updated
March 14, 2022
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Beijing 302 Hospital, Beijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05192538
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Beijing 302 Hospital, Beijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD, Reflux Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic endoloop pre-test treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Endoscopic endoloop pre-test treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
Description
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
Title
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
Description
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
Title
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
Description
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
Title
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
Description
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
Title
Improvement in GERD-Health Related Quality of Life (HRQL) questionnaire scores
Description
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
Title
Improvement in Reflux Symptom Index (RSI) questionnaire scores
Description
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
Title
Improvement in Reflux Symptom Index (RSI) questionnaire scores
Description
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
Title
Improvement in Reflux Symptom Index (RSI) questionnaire scores
Description
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
Title
Improvement in Reflux Symptom Index (RSI) questionnaire scores
Description
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
Title
Improvement in Reflux Symptom Index (RSI) questionnaire scores
Description
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
Secondary Outcome Measure Information:
Title
Effect on 24-hours esophageal pH-impedance
Description
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
Title
Effect on 24-hours esophageal pH-impedance
Description
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
Title
Changes in DeMeester score
Description
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
Title
Changes in DeMeester score
Description
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
Title
Safety and Tolerability of the procedure
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
7 days
Title
Safety and Tolerability of the procedure
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
14 days
Title
Safety and Tolerability of the procedure
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
1 month

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Liu
Phone
13911798288
Email
13911798288@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Min Min
Phone
+8613426165452
Email
minmin823@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liu, Pro.
Organizational Affiliation
Beijing 302 Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fifth Medical Center of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Min
Phone
+8613426165452
Email
minmin823@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

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A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux

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