UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of long term quality of life after aboral pouch reconstruction compared with Roux-en-Y reconstruction after total gastrectomy for gastric cancer
Title of the study (Brief title)	Evaluation of long term quality of life after aboral pouch reconstruction compared with Roux-en-Y reconstruction after total gastrectomy
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare postoperative quality of life between aboral pouch reconstruction and Roux-en-Y reconstruction after total gastrectomy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare postoperative quality of life between aboral pouch reconstruction and Roux-en-Y reconstruction after total gastrectomy.
Key secondary outcomes	Scores of questionnaires;QLQ-C30, STO22 and PGSAS37, body composition, blood test, disease-free survival and overall survival.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	A: Roux-en-Y reconstruction
Interventions/Control_2	B: Aboral pouch reconstruction
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) Provided written informed consent 2) Patients who were enrolled in CCOG1101 study (Evaluation of Aboral Pouch Reconstruction After Total Gastrectomy in Patients with Gastric Cancer : A Prospective Randomized Controlled Trial)
Key exclusion criteria	1) Considered inadequate for inclusion in this trial by the physician 2) Patients without consent for enrollment
Target sample size	100

Research contact person
Name of lead principal investigator	Yasuhiro Kodera
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery (Surgery II)
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2250
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	Chie Tanaka
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery (Surgery II)
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2250
Homepage URL
Email	chtanaka@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2015 Year 08 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 15 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 30 Day
Last modified on	2018 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021810