UMIN-CTR Clinical Trial

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
Institute	Prince of Songkla University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044469