UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016781
Receipt No. R000019100
Scientific Title The analysis of risk facotors of post colon ESD pain
Date of disclosure of the study information 2015/03/11
Last modified on 2019/12/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The analysis of risk facotors of post colon ESD pain
Acronym The analysis of risk facotors of post colon ESD pain
Scientific Title The analysis of risk facotors of post colon ESD pain
Scientific Title:Acronym The analysis of risk facotors of post colon ESD pain
Region
Japan

Condition
Condition The adapted lesion of colon ESD
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the risk factor of post colon ESD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Pain scale (Visula analog scale) (POD1, POD2, POD3 and POD4)
Key secondary outcomes Size of the lesion
Location of the lesion
Time of procedure
Use of analgetic agent
Use of antiboitics

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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with ESD adapted colonic lesions
Key exclusion criteria History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure
Histroy of regular use of analgesic
Pregnancy or possibility of pregnancy
Patients judged as being inappropriate candidates for the trial by the investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takuma
Middle name
Last name Higurashi
Organization Yokohama City University
Division name Department of endoscopy
Zip code 236-0004
Address 3-9 Fukuura Kanazawa Yokohama Japan
TEL 045-787-2640
Email takuma_h@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Takuma
Middle name
Last name Higurashi
Organization Yokohama City University
Division name Department of endoscopy
Zip code 236-0004
Address 3-9 Fukuura Kanazawa Yokohama Japan
TEL 045-787-2640
Homepage URL
Email takuma_h@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Omori Red Cross Hospital
NTT Medical Center Tokyo
Hiratsuka City Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama City University Hospital IRB
Address 3-9 Fukuura Kanazawa-ku Yokohama City
Tel 045-787-2640
Email irb@yokohama-cu.ac.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 横浜市立大学 大森赤十字病院 NTT関東病院 平塚市民病院

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 11 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5842075/
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5842075/
Number of participants that the trial has enrolled 106
Results
Female gender, location of lesion in the cecum, and ESD operation time >?90 minutes were significant risk factors independent of PECS. These findings are important to management of PECS.?
Results date posted
2019 Year 12 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2017 Year 03 Month 07 Day
Baseline Characteristics
This was a prospective multicenter observational trial (UMIN000016781) conducted in 106 of 223 patients who underwent ESD between March 2015 and April 2016. We investigated age, sex, tumor location, ESD operation time, lesion size, duration of hospitalization, and frequency of PECS.?We defined PECS as local abdominal pain (evaluated on a visual analogue scale) in the region corresponding to the site of the ESD that occurred within 4 days of the procedure.
Participant flow
This was a prospective multicenter observational trial (UMIN000016781) conducted in 106 of 223 patients who underwent ESD between March 2015 and April 2016. We investigated age, sex, tumor location, ESD operation time, lesion size, duration of hospitalization, and frequency of PECS.?We defined PECS as local abdominal pain (evaluated on a visual analogue scale) in the region corresponding to the site of the ESD that occurred within 4 days of the procedure.
Adverse events
PECS occurred in 15/106 (14.2?%), and 10 were women ( P ?=?0.01, OR: 7.74 [1.6?-?36.4]), 7 had lesions in the cecum ( P ?<?0.001, OR: 20.6 [3.7?-?115.2]), and 9 in whom ESD operation time was >?90?min ( P ?=?0.002, OR: 10.3 [2.4?-?44.6]). Frequency of deviation from the prescribed clinical path was significantly higher (47?% [7/15] vs. 2?% [2/91], P ?<?0.001, OR: 38.9 [6.9?-?219.6]), and hospital stay was significantly longer in the PECS group.
Outcome measures
PECS occurred in 15/106 (14.2?%), and 10 were women ( P ?=?0.01, OR: 7.74 [1.6?-?36.4]), 7 had lesions in the cecum ( P ?<?0.001, OR: 20.6 [3.7?-?115.2]), and 9 in whom ESD operation time was >?90?min ( P ?=?0.002, OR: 10.3 [2.4?-?44.6]). Frequency of deviation from the prescribed clinical path was significantly higher (47?% [7/15] vs. 2?% [2/91], P ?<?0.001, OR: 38.9 [6.9?-?219.6]), and hospital stay was significantly longer in the PECS group.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
2015 Year 02 Month 28 Day
Anticipated trial start date
2015 Year 03 Month 11 Day
Last follow-up date
2017 Year 02 Month 28 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 04 Month 30 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information Prospective observational Study

Management information
Registered date
2015 Year 03 Month 11 Day
Last modified on
2019 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019100

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.