UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018167
Receipt number R000019817
Scientific Title The usefulness of endoscopic submucosal dissection (ESD) with continuous aspiration catheter attached outside the endoscope for superficial esophageal carcinoma
Date of disclosure of the study information 2015/07/02
Last modified on 2020/01/04 09:43:02

* 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 usefulness of endoscopic submucosal dissection (ESD) with continuous aspiration catheter attached outside the endoscope for superficial esophageal carcinoma

Acronym

Esophageal aspiration catheter study

Scientific Title

The usefulness of endoscopic submucosal dissection (ESD) with continuous aspiration catheter attached outside the endoscope for superficial esophageal carcinoma

Scientific Title:Acronym

Esophageal aspiration catheter study

Region

Japan


Condition

Condition

Superficial esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of continuous aspiration catheter attached outside the endoscope in performing endoscopic submucosal dissection for superficial esophageal cancers

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Excretion from the mouth in performing esophageal ESD

Key secondary outcomes

the rate of (aspiration) pneumonia after performing esophaeal ESD
the time in performing esophageal ESD
the relationship between inserting water for washing from the endoscope and excretion from the mouth in performing esophageal ESD


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

esophageal ESD with continuous aspiration catheter

Interventions/Control_2

esophageal ESD without continuous aspiration catheter

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) The patients with previous surgery in esophagus, stomach, or head and neck.
2) The patients with the diagnosis of esophageal stenosis or achalasia

Key exclusion criteria

1) The patients with previous surgery in esophagus, stomach, or head and neck.
2) The patients with the diagnosis of esophageal stenosis or achalasia
3) The patients with chemoradiotherapy for any cancer
4) The patients with underlying diseases which does not permit the use of butylscopolamine

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Waku
Middle name
Last name Hatta

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Gastroenterology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7171

Email

waku-style@festa.ocn.ne.jp


Public contact

Name of contact person

1st name Waku
Middle name
Last name Hatta

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Gastroenterology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7171

Homepage URL


Email

waku-style@festa.ocn.ne.jp


Sponsor or person

Institute

Division of Gastroenterology, Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Gastroenterology, Tohoku University Graduate School of Medicine

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

The Ethics Committee, Tohoku University Hospital

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Japan

Tel

022-717-7122

Email

med-kenkyo@bureau.tohoku.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

2015 Year 07 Month 02 Day


Related information

URL releasing protocol

None

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/30861606

Number of participants that the trial has enrolled

50

Results

Volume of liquid reflux to the mouth was significantly lower in the continuous liquid-suction catheter attachment for the endoscope-endoscopic submucosal dissection group (CLCA-ESD group) than in the conventional endoscopic submucosal dissection group (C-ESD group) (mean: 10 vs 73 mL, P = 0.010).

Results date posted

2020 Year 01 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

There was no significant difference of baseline characteristics of the enrolled patients between the two groups.

Participant flow

Fifty patients who met the eligibility criteria but did not meet the exclusion criteria were randomly assigned to the CLCA-ESD or C-ESD groups, and completed this study.

Adverse events

None

Outcome measures

Volume of liquid reflux to the mouth:
CLCA-ESD group, mean 10 mL
C-ESD group, mean 73 mL

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 05 Month 20 Day

Date of IRB

2015 Year 06 Month 26 Day

Anticipated trial start date

2015 Year 12 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 02 Day

Last modified on

2020 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019817


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name