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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004941
Receipt No. 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

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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
Institute National Cancer Center Hospital East
Institute
Department

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
URL(English) https://upload.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


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