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

Email

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

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name