UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027135
Receipt number R000031094
Scientific Title The study of the resting energy metabolism and stress factor using an indirect calorimeter in the perioperative period of endoscopic operation
Date of disclosure of the study information 2017/04/26
Last modified on 2022/05/04 11:35:20

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Basic information

Public title

The study of the resting energy metabolism and stress factor using an indirect calorimeter in the perioperative period of endoscopic operation

Acronym

invasiveness of endoscopic operation

Scientific Title

The study of the resting energy metabolism and stress factor using an indirect calorimeter in the perioperative period of endoscopic operation

Scientific Title:Acronym

invasiveness of endoscopic operation

Region

Japan


Condition

Condition

gactric cancer, colorectal cancer, esophageal cancer, esophageal achalasia

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

invasiveness of endoscopic operation

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

resting energy expenditure and the stress factor on endoscopic operation postoperative day 1

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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 undergo endoscopic operation
2)written informed concent

Key exclusion criteria

patients with cirrhosis of the liver, respiratory disease, or who are recieving dialysis or treatment of other malignant tumor

Target sample size

75


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Chinda

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Gastroenterology and Hematology

Zip code

036-8562

Address

5 Zaifu-cho, Hirosaki, Aomori

TEL

0172-33-5111

Email

donkeyra3@yahoo.co.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Chinda

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Gastroenterology and Hematology

Zip code

036-8562

Address

5 Zaifu-cho, Hirosaki, Aomori

TEL

0172-33-5111

Homepage URL


Email

donkeyra3@yahoo.co.jp


Sponsor or person

Institute

Hirosaki University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hirosaki University Graduate School of Medicine

Address

5 Zaifu-cho, Hirosaki, Aomori

Tel

0172-33-5111

Email

donkeyra3@yahoo.co.jp


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 04 Month 26 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/28955134

Number of participants that the trial has enrolled


Results

The stress factor on the postoperative day 1 by gastric and colorectal ESD increased significantly. However, they were low in comparison to that experienced for surgery, suggesting that the degree of perioperative invasiveness in patients receiving ESD is lower in comparison to that during surgery.

Results date posted

2020 Year 04 Month 17 Day

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

2013 Year 04 Month 05 Day

Date of IRB

2013 Year 05 Month 15 Day

Anticipated trial start date

2013 Year 07 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients who undergo endoscopic therapy
for gactric cancer, colorectal cancer, esophageal cancer and esophageal achalasia at Hirosaki University Hospital.


Management information

Registered date

2017 Year 04 Month 26 Day

Last modified on

2022 Year 05 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031094


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name