UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017302 |
|---|---|
| Receipt number | R000020077 |
| Scientific Title | Study about efficacy of Dexmedetomidine as a novel sedative agent during ESD for esophageal cancer |
| Date of disclosure of the study information | 2015/04/28 |
| Last modified on | 2018/12/21 14:45:10 |
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Basic information
Public title
Study about efficacy of Dexmedetomidine as a novel sedative agent during ESD for esophageal cancer
Acronym
Efficacy of Dexmedetomidine during esophageal ESD
Scientific Title
Study about efficacy of Dexmedetomidine as a novel sedative agent during ESD for esophageal cancer
Scientific Title:Acronym
Efficacy of Dexmedetomidine during esophageal ESD
Region
| Japan |
Condition
Condition
Esophageal cancer (SCC)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of new sedation using Dexmedetomidine during ESD for esophageal cancer in prospective study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The ratio of the cases with no body movement during ESD
Key secondary outcomes
1 The frequency of respiratory depression, hypotention and bradycardia
2 Patients' levels of conciousness and suffer
3 Endoscopists' satisfaction level for sedation
4 Efficacy of BIS
5 Total consumed amount of midazolam and pethidine hydrochloride
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sadation by dexmedetomidine, midazolam and pethidine hydrochloride during esophageal ESD
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Histologically diagnosed squamous cell carcinoma by endoscopic biopsy
2 SM1 or less in tumor invasion by preoperative diagnosis
3 Located in Ut/Mt/Lt/Ae, and able to perform ESD without intubation
4 No lymph node or distant metastasis by preoperative CT
5 Age is 20-80
6 Performance status is 0-2
7 No severe organ dysfunction
8 Written informed consent are obtained
Key exclusion criteria
1 Uncontrollable hypertention
2 Uncontrollable heart disease or arrhythmia
3 Respiratory disease needed oxygen in rest
4 Unstable angina (newly occurred or worsened in these 3 weeks) or myocardial infarction within 6 months
5 Difficult to discontinue antithrombotic drugs during preoperative period
6 Severe infectious disease needed systemic treatment
7 Patients judged inappropriate by investigator or attending doctor
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Yoshio |
Organization
Cancer Institute Hospital
Division name
Gstroenterology
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
toshiyuki.yoshio@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Yoshio |
Organization
Cancer Institute Hospital
Division name
Gastroenterology
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
Homepage URL
toshiyuki.yoshio@jfcr.or.jp
Sponsor or person
Institute
Department of Gastroenterology,Cancer Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
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
がん研有明病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 28 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020077
