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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021487
Receipt No. R000024784
Scientific Title A prospective comparative study of the sedation between a combination of propofol and dexmedetomidine hydrochloride and propofol alone in esophageal endoscopic submucosal dissection.
Date of disclosure of the study information 2016/03/20
Last modified on 2016/11/14

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Basic information
Public title A prospective comparative study of the sedation between a combination of propofol and dexmedetomidine hydrochloride and propofol alone in esophageal endoscopic submucosal dissection.
Acronym Evaluation of the sedation with a combination of PF and DEX during esophageal ESD.
Scientific Title A prospective comparative study of the sedation between a combination of propofol and dexmedetomidine hydrochloride and propofol alone in esophageal endoscopic submucosal dissection.
Scientific Title:Acronym Evaluation of the sedation with a combination of PF and DEX during esophageal ESD.
Region
Japan

Condition
Condition Superficial esophageal carcinomas or intraepithelial neoplasias scheduled for ESD.
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of sedation with a combination of propofol (PF) and dexmedetomidine hydrochloride (DEX) compared with sedation with PF alone during esophageal endoscopic submucosal dissection (ESD).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The occurrence of excess body movement during ESD.
Key secondary outcomes ESD outcomes (including en bloc resection rate, complete resection rate and procedure times).
The occurrence of procedure-related and sedation-related complication.
The degree of satisfaction for ESD among physicians and assistants using a visual analog scale.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The sedation with a combination of propofol and dexmedetomidine hydrochloride.
Interventions/Control_2 The sedation with propofol alone.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with superficial esophageal carcinomas and intraepithelial neoplasias scheduled for ESD.
Key exclusion criteria Patients classified with an ASA physical status higher than II.
Patients with a tracheotomy.
Patients with any airway disorder.
Patients with a cardiac pacemaker.
Patients with gastric tube after esophageal surgery.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nonaka Takashi
Organization Yokohama City University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL 045-787-2640
Email nonaka_taka@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nonaka Takashi
Organization Yokohama City University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL 045-787-2640
Homepage URL
Email nonaka_taka@yahoo.co.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 20 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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 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
2016 Year 03 Month 16 Day
Last modified on
2016 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024784

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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