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 |
* 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
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
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
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
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
