본문바로가기



  • Status : Approved
    • First Submitted Date : 2021/01/06
    • Registered Date : 2021/01/13
    • Last Updated Date : 2021/01/06
  • 페이스북공유하기
  • 트위터공유하기
  • 구글플러스공유하기
  • 카카오스토리공유하기
  • 네이버밴드공유하기
  • 출력

1. Background

Background Information
CRIS
Registration Number
KCT0005779 
Unique Protocol ID 2020-1283 
Public/Brief Title Esophagogastric junction and esophageal body assessed with an endoscopic functional luminal imaging probe (EndoFLIP) in healthy volunteers 
Scientific Title Esophagogastric junction and esophageal body assessed with an endoscopic functional luminal imaging probe (EndoFLIP) in healthy volunteers  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number 2020-1283 
Approval Date 2020-08-14 
Institutional Review Board  
Name Institutional review board of Asan Medical Center  
Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul 
Telephone 02-3010-7166 
Data Monitoring Committee  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Do Hoon Kim 
Title MD, PhD 
Telephone +82-2-3010-3193 
Affiliation Asan Medical Center 
Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea 
Contact Person for Public Queries
Name Do Hoon Kim 
Title MD, PhD 
Telephone +82-2-3010-3193 
Affiliation Asan Medical Center 
Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea 
Contact Person for Updating Information
Name Do Hoon Kim 
Title MD, PhD 
Telephone +82-2-3010-3193 
Affiliation Asan Medical Center 
Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea 

4. Status

Status Information
Study Site Multi-center (Number of center : 2)
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2021-01-18 , Anticipated
Target Number of Participant 20
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1
Name of Study Site Asan Medical Center 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2021-01-18 , Anticipated
Recruitment Status by Participating Study Site 2
Name of Study Site Yonsei University Health System, Gangnam Severance Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2021-02-01 , Anticipated

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name The Korean Society of Neurogastroenterology and Motility 
Organization Type Others  
Project ID KSNM-20-01 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Asan Medical Center 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary Achalasia, gastroesophageal reflux disease, etc. are representative diseases that show abnormal distensibility of the gastroesophageal junction. In the case of achalasia, the distensibility of the gastroesophageal junction is reduced, thereby limiting the movement of bolus from the esophagus to the stomach, and dysphagia occurs. Gastroesophageal reflux disease increases the distensibility of the gastroesophageal junction, causing gastric reflux into the esophagus.
Esophageal manometry, which measures and analyzes the pressure and amplitude of the esophageal body and gastroesophageal junction, has been used as a test to exam the motor function of the esophagus, but this method has a limitation that it cannot be measured the important characteristic that affects the movement of the bolus, such as esophageal wall compliance, compliance and the diameter of the lumen of the esophagus. In particular, the gastroesophageal junction is opened in response to pressure by the flow of material in the lumen, and this pressure-geometric data cannot be fully evaluated with an manometry.
The recently developed esophageal lumen real-time balloon distensibility test (EndoFLIP®, Endoluminal functional lumen imaging probe) is used to evaluate the lower esophageal sphincter and lower esophagus in patients with achalasia, eosinophilic esophagitis, and reflux esophagitis.
EndoFLIP® is a catheter with a length of 240 cm and an outer diameter of 3 mm. An 8 cm long balloon is mounted on the distal part, and there are 17 electrodes at intervals of 5 mm inside the balloon. Using the principle of impedance area measurement, the shape, pressure, length, cross-sectional area, and distensibility can be measured. In addition to the lower esophageal sphincter, EndoFLIP® is also used to evaluate the correlation between the dynamics and symptoms of the pyloric sphincter. In patients with gastroparesis characterized by delayed gastric emptying such as early satiety, nausea, vomiting, postprandial fullness, and epigastric pain, without mechanical obstruction, the mean pressure of the pyloric sphincter increased and compliance decreased compared to the control group.
In this way, there is an advantage in that it provides additional information that could not be obtained in the existing test methods in various areas, but the standardized protocol and reference value have not been established so far, so different results are shown for each study.
Therefore, this study can help diagnose and evaluate the treatment of Korean patients with achalasia, gastroesophageal reflux disease, and gastroparesis by confirming the normal reference values of the lower esophageal sphincter and pyloric sphincter.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Diagnosis    
Phase Not applicable 
Intervention Model Single Group  
Blinding/Masking Open 
Allocation Not Applicable 
Intervention Type Medical Device  
Intervention Description After fasting for more than 8 hours, an EndoFLIP® catheter (EF-325N, Crospon, Galway, Ireland) is orally inserted under endoscopic guidance during endoscopy performed with the left supine position. After placing the center of the balloon catheter in the gastroesophageal junction, measure the parameters while inflating the balloon with 30 mL, 40 mL, and 50 mL of normal saline according to the protocol. After that, hold the pre-mounted knot on the tip of the balloon catheter with the biopsy forcep, pull it to the pylorus, place the center of the balloon catheter in the pylorus, and measure the variables in the same way.  
Number of Arms
Arm 1 Arm Label healthy volunteers 
Target Number of Participant 20 
Arm Type Experimental 
Arm Description After fasting for more than 8 hours, an EndoFLIP® catheter (EF-325N, Crospon, Galway, Ireland) is orally inserted under endoscopic guidance during endoscopy performed with the left supine position. After placing the center of the balloon catheter in the gastroesophageal junction, measure the parameters while inflating the balloon with 30 mL, 40 mL, and 50 mL of normal saline according to the protocol. After that, hold the pre-mounted knot on the tip of the balloon catheter with the biopsy forcep, pull it to the pylorus, place the center of the balloon catheter in the pylorus, and measure the variables in the same way. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Not Applicable
 healthy volunteers
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ 70 Year
Description Asymptomatic healthy Korean men and women aged 20 to 70 who visited the hospital for stomach cancer screening  
Exclusion Criteria ① Those with symptoms of esophageal and gastric dysfunction <br />② Those who do not understand the purpose of the study or disagree with the exmaination <br />③ Those with a history of abdominal or chest surgery <br />④ Those who have taken drugs that affect esophageal and gastric function within the last 2 weeks <br />⑤ Those who have been diagnosed with a malignant disease <br />⑥ Those with a bleeding-tendency disease or taking anticoagulant or antiplatelet drugs <br />⑦ Those with systemic disease receiving treatment  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
Outcome Distensibility, diameter, compliance, cross sectional area 
Timepoint during endoscopic examination 
Secondary Outcome(s) 1 
Outcome adverse events 
Timepoint during endoscopic examination 

11. Study Results and Publication

Study Results and Publication Information
Result Registered No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
  • 출력
Quick Link
자주하시는 질문
1:1 문의
등록절차
입력항목설명집