UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of digestive and absortive function after major upper gastrointestinal surgery with 13C glucose breath test: a Prospective study.
Acronym	Evaluation of digestive and absortive function after major upper gastrointestinal surgery with 13C glucose breath test: a Prospective study.
Scientific Title	Evaluation of digestive and absortive function after major upper gastrointestinal surgery with 13C glucose breath test: a Prospective study.
Scientific Title:Acronym	Evaluation of digestive and absortive function after major upper gastrointestinal surgery with 13C glucose breath test: a Prospective study.
Region	Japan

Condition
Condition	Patients who will undergo major upper gastrointestinal surgery
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to search for digestive and absortive change after major upper surgery with 13C glucose breath test. And to search for change in perioperative period or difference depending on operative method.
Basic objectives2	Others
Basic objectives -Others	Change in Digestive and absortive function
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of change in 13C-glucose which is digested , absorved and excreted,comparing before and a year after surgery.
Key secondary outcomes	*Change in total excretion amount of 13c-glucose at before and 3 months after, 6 months after, 24months after surgery. *Body weight change *Change in grip strength *Questionnaire about symptom and QOL *Change in laboratory data *blood loss during surgery, operative time, hospital stay.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	13C-glucose breath test
Interventions/Control_2
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	1)patients who will have an upper gastrointestinal surgery (includindg open, laparoscopic and robot-assisted surgery) at our depaetment. 2)Over 20 years old 3)Patients who received a sufficient explanation about the purpose and content of this study , have a consent ability and volunteered to participate in the understanding and can agree to this study participation in writing
Key exclusion criteria	1)patients who have received enterectomy(except appendectomy and colon polypectomy) 2)patients who have other malignancy 3)patients who are unable to quit smoking 4) Patients who are diagnosed paroxysmal nocturnal hemoglobinuria 5) Diabetic patient treating with insulin. 6)Patients with severe liver disease(AST(GOT)orALT(GPT)>=100IU/L) 7)A woman during pregnancy or potential pregnancy. 8) lactating women 9)patients who have allergic for wheat or milk 10 )Patient who have lactose intolerance 11)when the physician in chief decides the patient is inappropriate for this protocol
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yasuyuki Seto
Organization	The University of Tokyo Hospital
Division name	Gastrointestinal Surgery
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	seto-tky@umin.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Asami Tanabe
Organization	The University of Tokyo Hospital
Division name	Gastrointestinal Surgery
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	TANABEA-SUR@h.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	self funding
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	2017 Year 01 Month 16 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	Terminated
Date of protocol fixation	2016 Year 09 Month 26 Day
Date of IRB	2016 Year 08 Month 31 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 01 Month 16 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027480