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Recruitment status Terminated
Unique ID issued by UMIN UMIN000025696
Receipt No. R000027480
Scientific Title Evaluation of digestive and absortive function after major upper gastrointestinal surgery with 13C glucose breath test: a Prospective study.
Date of disclosure of the study information 2017/01/16
Last modified on 2019/03/13

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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