UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015353 |
|---|---|
| Receipt number | R000017861 |
| Scientific Title | Efficacy of two balloon radial EUS for esophageal or duodenal lesions |
| Date of disclosure of the study information | 2014/10/06 |
| Last modified on | 2014/10/06 20:35:24 |
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Basic information
Public title
Efficacy of two balloon radial EUS for esophageal or duodenal lesions
Acronym
Two balloon confined EUS
Scientific Title
Efficacy of two balloon radial EUS for esophageal or duodenal lesions
Scientific Title:Acronym
Two balloon confined EUS
Region
| Japan |
Condition
Condition
Esophageal neoplasia or duodenal neoplasia
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop the precise diagnosis of esophageal and duodenal neoplasia using radial endoscopic ultrasound sonography (EUS) under sufficient deaerated water and favorable images could be obtained
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of accurate location and precise tumor size between conventional radial EUS and two ballon EUS
Key secondary outcomes
The location of tumor and VAS score (1to4) of clearness of tumor between conventional radial EUS and two ballon EUS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Making a grasping ring approximately 1 cm in diameter with a thread attached to the tip of a balloon (inner diameter, 10 mm; length, 32 mm) (TOP. Co, Tokyo, Japan) Using grasping forceps, we put the indwelling balloon to the distal side of the lesion. We fitted an identical balloon onto the endoscope itself to occlude both the distal and proximal sides of the lesion. The two balloons were expanded with approximately 10 ml air (balloon diameter: 20 mm); the esophagus, which was between the indwelling balloon and the balloon fitted onto the endoscope, was made into an occluded cavity. After expanded the balloon fitted onto the endoscope, all of the air of occluded cavity was aspirated, and filled with deaerated water. By performing two balloon occlusion radial EUS, diagnosed that the tumor located within the submucosal layer
Interventions/Control_2
Performed conventional radial EUS
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who suffered from esophagealtumor or duodenal tumor.
Key exclusion criteria
Patients who have esophageal or duodenal stenosis.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohito Mori |
Organization
Kagawa university
Division name
Department of Gastroenterology and Neurology
Zip code
Address
1720-1, Miki, Kida, Kagawa ,Japan
TEL
+81-87-891-2156
hiro4884@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kazunori Yamashita |
Organization
Ehime Rousai Hospital
Division name
Medical Affairs Division
Zip code
Address
13-27 Minamikomatsubara, Niihama, Ehime 792-8550, Japan
TEL
+81-897-33-6191
Homepage URL
ijikachou@ehimerosai.jp
Sponsor or person
Institute
Kagawa university
Institute
Department
Personal name
Funding Source
Organization
Kagawa university
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 06 | Day |
Last modified on
| 2014 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017861
