UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction from cancer (JIVROSG-0805)
Acronym	Randomized controlled trial of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction
Scientific Title	Randomized controlled trial of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction from cancer (JIVROSG-0805)
Scientific Title:Acronym	Randomized controlled trial of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction
Region	Japan

Condition
Condition	Gastrointestinal obstruction from cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical efficacy of percutaneous transesophageal gastric tubing (PTEG) in patients with gastrointestinal obstruction from cancer comparing with conventional nasal gastric tubing.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Improvement of the symptoms from nasal gastric tubing.
Key secondary outcomes	Improvement of health-related QOL and toxicity profile.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Percutaneous transesophageal gastric tubing (PTEG)
Interventions/Control_2	Nasal gastric tubing
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Gastrointestinal obstruction from cancer, such as upper GI obstruction from tumor or peritonitis, without possibility of symptom improvement by conventional treatments. 2. Contraindication to surgical treatments for gastrointestinal obstruction. 3. No disorder in the region of cervical esophagus. 4. Palliative prognosis index less than 6. 5. Twice measurement of symptom score and health-related quality-of-life. 6. Written informed consent from the patients.
Key exclusion criteria	1. Tracheal stoma by tracheostomy. 2. GI obstruction resulting from the lesion distal (annal side) to transverse colon. 3. Platelet count <50,000/mm3. 4. Locoregional treatment in the neck or planned locoregional treatment in the neck. 5. Pregnancy. 6. Contraindication decided by participating physician.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Takeshi Middle name Last name Aramaki
Organization	Shizuoka Cancer Center
Division name	Department of Imaging Diagnosis
Zip code	411-8777
Address	Shunto-gun, Shizuoka, Japan
TEL	03-3542-2511
Email	msone@athena.ocn.ne.jp

Public contact
1st name of contact person	1st name Yasuaki Middle name Last name Arai
Organization	National Cancer Center Hospital
Division name	Department of Diagnostic Radiology
Zip code	1040045
Address	5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL	03-3542-2511
Homepage URL	http://jivrosg.umin.jp/
Email	arai-y3111@mvh.biglobe.ne.jp

Sponsor
Institute	Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cancer Center Hospital
Address	5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
Tel	03-3542-2511
Email	msone@me.com

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	愛知県がんセンター中央病院（愛知県）、旭川厚生病院（北海道）、岩手医科大学（岩手県）、群馬大学医学部附属病院（群馬県）、国立がんセンター中央病院（東京都）、静岡県立静岡がんセンター（静岡県）、手稲渓仁会病院（北海道）、栃木県立がんセンター（栃木県）

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 05 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	2008 Year 08 Month 06 Day
Date of IRB	2009 Year 09 Month 24 Day
Anticipated trial start date	2009 Year 11 Month 01 Day
Last follow-up date	2015 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 05 Month 05 Day
Last modified on	2019 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004325