UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032804
Receipt number R000037351
Scientific Title Prospective, double-blind, randomized controlled trial on efficacy of lidocaine injection method during esophageal endoscopic submucosal dissection.
Date of disclosure of the study information 2018/06/01
Last modified on 2022/12/05 19:06:31

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Basic information

Public title

Prospective, double-blind, randomized controlled trial on efficacy of lidocaine injection method during esophageal endoscopic submucosal dissection.

Acronym

LIM study

Scientific Title

Prospective, double-blind, randomized controlled trial on efficacy of lidocaine injection method during esophageal endoscopic submucosal dissection.

Scientific Title:Acronym

LIM study

Region

Japan


Condition

Condition

early esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficacy of lidocaine injection in esophageal ESD

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

body movement during ESD

Key secondary outcomes

Treatment time
Dose of midazolam
Postoperative pain
Complication (bleeding, perforation, Aspiration pneumonia, Hypoxemia, bradycardia, hypotension)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Esophageal ESD with lidocaine injection

Interventions/Control_2

Esophageal ESD without lidocaine injection

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

18 years-old <=

Age-upper limit

95 years-old >

Gender

Male and Female

Key inclusion criteria

Patients performed ESD for esophageal cancer

Key exclusion criteria

General anesthetic management
Lidocaine allergy
Patients with severe systemic disease(>ASA4)
Patients without informed consent
Patients already enrolled in the same study
Considered by a study physician to be inappropriate for any other reason

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Tetsuya
Middle name
Last name Yoshizaki

Organization

Saiseikai Nakatsu Hospital

Division name

gastroenterology

Zip code

530-0012

Address

2-10-39 Shibata, Kita-ku, Osaka 530-0012, Japan

TEL

06-6372-0333

Email

yoshizak@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Tetsuya
Middle name
Last name Yoshizaki

Organization

Saiseikai Nakatsu Hospital

Division name

gastroenterology

Zip code

530-0012

Address

2-10-39 Shibata, Kita-ku, Osaka 530-0012, Japan

TEL

06-6372-0333

Homepage URL


Email

yoshizak@med.kobe-u.ac.jp


Sponsor or person

Institute

Saiseikai Nakatsu Hospital

Institute

Department

Personal name



Funding Source

Organization

Saiseikai Nakatsu Hospital

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

Saiseikai Nakatsu Hospital

Address

2-10-39 Shibata, Kita-ku, Osaka 530-0012, Japan

Tel

06-6372-0333

Email

yoshizak@med.kobe-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



Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 01 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

No longer recruiting

Date of protocol fixation

2018 Year 05 Month 28 Day

Date of IRB

2018 Year 05 Month 10 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2021 Year 06 Month 01 Day

Date of closure to data entry

2021 Year 12 Month 01 Day

Date trial data considered complete

2022 Year 10 Month 01 Day

Date analysis concluded

2022 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2018 Year 05 Month 31 Day

Last modified on

2022 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037351


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name