UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041171
Receipt number R000045723
Scientific Title Efficacy of underwater endoscopic mucosal resection for sessile serrated lesions.
Date of disclosure of the study information 2020/07/20
Last modified on 2021/01/22 20:30:11

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Basic information

Public title

Efficacy of underwater endoscopic mucosal resection for sessile serrated lesions.

Acronym

CS-UEMR study

Scientific Title

Efficacy of underwater endoscopic mucosal resection for sessile serrated lesions.

Scientific Title:Acronym

CS-UEMR study

Region

Japan


Condition

Condition

sessile serrated lesion

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of underwater endoscopic mucosal resection for serrated lesions of 10 to 20mm.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

complete resection rate

Key secondary outcomes

R0 resection rate
En bloc resection rate
Recurrence rate
Procedure time
difficult-to-resect factors of UEMR
Adverse events
Histology


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

Sessile serrated lesions 10-20mm in size
Sessile serrated lesions confirmed by Narrow band imaging or chromoendoscopy.

Key exclusion criteria

Suspicious of cancer or adenoma
Familial adenomatous polyposis
Inflammatory bowel disease
Infectious disease with systemic therapy indicated
Pregnant or nursing
Impossible to perform UEMR due to antithrombotic drugs
Short prognosis (within one year)
Other inappropriate cases

Target sample size

102


Research contact person

Name of lead principal investigator

1st name Yasushi
Middle name
Last name Yamasaki

Organization

Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama university

Division name

Department of Misasa Community Medicine

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama

TEL

+81-86-235-7219

Email

yasshifive@yahoo.co.jp


Public contact

Name of contact person

1st name Masayasu
Middle name
Last name Ohmori

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama

TEL

+81-86-235-7219

Homepage URL


Email

masayasu.ohmori@gmail.com


Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

Okayama University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Iwakuni Clinical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee

Address

2-5-1, Shikata-cho, Kita-ku, Okayama

Tel

+81-86-235-7361

Email

ouh-crrb@adm.okayama-u.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

岡山大学病院(岡山県)、岩国医療センター(山口県) 


Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 20 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

Open public recruiting

Date of protocol fixation

2020 Year 07 Month 17 Day

Date of IRB

2020 Year 07 Month 17 Day

Anticipated trial start date

2020 Year 07 Month 20 Day

Last follow-up date

2025 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Evaluate the effectiveness of Underwater EMR.
Biopsies will be taken from 4 points around the treatment area of UEMR for evaluation of residuals.
Colonoscopy will be performed 5 to 13 months after UEMR.


Management information

Registered date

2020 Year 07 Month 20 Day

Last modified on

2021 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045723


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name