UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004941
Receipt number R000005584
Scientific Title A phase 2 study of endoscopic submucosal dissection (ESD) using a new Single Use Electrosurgical Knife for early esophageal or gastric cancer
Date of disclosure of the study information 2011/02/01
Last modified on 2014/06/13 11:32:50

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Basic information

Public title

A phase 2 study of endoscopic submucosal dissection (ESD) using a new Single Use Electrosurgical Knife for early esophageal or gastric cancer

Acronym

A phase 2 study of ESD using a new Single Use Electrosurgical Knife

Scientific Title

A phase 2 study of endoscopic submucosal dissection (ESD) using a new Single Use Electrosurgical Knife for early esophageal or gastric cancer

Scientific Title:Acronym

A phase 2 study of ESD using a new Single Use Electrosurgical Knife

Region

Japan


Condition

Condition

Early esophageal and gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of endoscopic submucosal dissection using a new Single Use Electrosurgical Knife for early esophageal or gastric cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Proportion of serious adverse events related to ESD

Key secondary outcomes

Proportion of en-bloc resection, Adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

endoscopic submucosal dissection using a new Single Use Electrosurgical Knife

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Primary and single gastric or esophageal cancer.
2) Endoscopic findings of each tumor as follows.
Gastric cancer:
2)-1 Histologically proven differentiated adenocarcinoma by biopsy. A mixed case of undifferentiated components is not eligible.
2)-2 Size of tumor is <=2cm without ulcer or ulcer scar.
2)-3 Depth of invasion is clinical M.
Esophageal cancer:
2)-1 Size of tumor is <=3cm
2)-2 Depth of invasion is clinical m1 or m2.
2)-3 Histologically proven squamous cell carcinoma or basaloid carcinoma by biopsy.
3) En-bloc resection is possible with ESD.
4) The possibility of stenosis after ESD is low. i.e. the location of each tumor meets the all following criterion.
Gastric cancer:
4)-1 Tumor invasion of the pylorus or cardia is not observed.
Esophageal cancer:
4)-1 Tumor is located within the thoracic esophagus
4)-2 Circularity is two-thirds or less.
5) Aged 20 to 75 years old.
6) PS (ECOG) of 0 or 1.
7) Past treatments as follows.
Gastric cancer:
No endoscopic treatment for gastric cancer
Esophageal cancer:
No endoscopic treatment for esophageal cancer
8) No prior treatment of surgery, chemotherapy (including endocrinotherapy) or radiation therapy for cancer.
9) Sufficient organ functions.
10) Written informed consent.

Key exclusion criteria

1) Impossible to discontinue anticoagulant or antiplatelet medications.
2) Women during pregnancy or breast-feeding.
3) Psychosis.
4) Systemic steroids medication.
5) Active bacterial or fungous infection.
6) History of myocardial infarction or unstable angina pectoris within three months.
7) Uncontrollable hypertension.
8) Uncontrollable diabetes mellitus or administration of insulin.
9) Severe respiratory disease requiring continuous oxygen therapy.

Target sample size

103


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshihiko Doi

Organization

National Cancer Center Hospital East

Division name

Gastrointestinal Oncology Division

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

National Cancer Center Hospital East

Division name

Gastrointestinal Oncology Division

Zip code


Address


TEL

04-7133-1111

Homepage URL


Email



Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



Funding Source

Organization

Olympus Medical Systems Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2011 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/24770969

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

Terminated

Date of protocol fixation

2010 Year 09 Month 09 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 Day

Last follow-up date

2012 Year 02 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 01 Month 25 Day

Last modified on

2014 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005584


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name