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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name