UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038996 |
|---|---|
| Receipt number | R000044469 |
| Scientific Title | Esophageal dilation and percutaneous endoscopic gastrostomy (PEG) : RCT study between intravenous sedation vs general anesthesia. |
| Date of disclosure of the study information | 2019/12/25 |
| Last modified on | 2019/12/25 16:31:23 |
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Basic information
Public title
Esophageal dilation and percutaneous endoscopic gastrostomy (PEG) : RCT study between intravenous sedation vs general anesthesia.
Acronym
Esophageal dilation and percutaneous endoscopic gastrostomy (PEG) : RCT study between intravenous sedation vs general anesthesia.
Scientific Title
Esophageal dilation and percutaneous endoscopic gastrostomy (PEG) : RCT study between intravenous sedation vs general anesthesia.
Scientific Title:Acronym
Esophageal dilation and percutaneous endoscopic gastrostomy (PEG) : RCT study between intravenous sedation vs general anesthesia.
Region
| Asia(except Japan) |
Condition
Condition
patient
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
cost
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
cost
Key secondary outcomes
time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
General anesthesia
Interventions/Control_2
Intravenous sedation
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
| 18 | years-old | < |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
esophageal cancer
Key exclusion criteria
Patients who are unfit to surgery such as ASA class 4-5.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Somkiat |
| Middle name | |
| Last name | Sunpaweravong |
Organization
Prince of Songkla University, Sonkla, Thailand
Division name
Prince of Songkla University, Sonkla, Thailand
Zip code
90110
Address
Prince of Songkla University, Sonkla, Thailand
TEL
66869663780
susomkia@medicine.psu.ac.th
Public contact
Name of contact person
| 1st name | Somkiat |
| Middle name | |
| Last name | Sunpaweravong |
Organization
Prince of Songkla University, Sonkla, Thailand
Division name
Prince of Songkla University, Sonkla, Thailand
Zip code
90110
Address
Prince of Songkla University, Sonkla, Thailand
TEL
66869663780
Homepage URL
http://medinfo.psu.ac.th
susomkia@medicine.psu.ac.th
Sponsor or person
Institute
Prince of Songkla University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Thailand
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prince of Songkla University, Sonkla, Thailand
Address
Prince of Songkla University, Sonkla, Thailand
Tel
6674455000
surgery@medicine.psu.ac.th
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
| 2019 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 25 | Day |
Last modified on
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044469
