UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025696 |
|---|---|
| Receipt number | 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 09:47:50 |
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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
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
TANABEA-SUR@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027480
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