UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018965 |
|---|---|
| Receipt number | R000010770 |
| Scientific Title | Research for standardization of operative method of free jejunum transfer |
| Date of disclosure of the study information | 2015/09/10 |
| Last modified on | 2017/03/14 08:58:57 |
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Basic information
Public title
Research for standardization of operative method of free jejunum transfer
Acronym
Research for standardization of free jejunum transfer
Scientific Title
Research for standardization of operative method of free jejunum transfer
Scientific Title:Acronym
Research for standardization of free jejunum transfer
Region
| Japan |
Condition
Condition
Hypopharyngeal cancer, Cervical esophageal cancer
Classification by specialty
| Oto-rhino-laryngology | Plastic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of cranio-caudaly tensed free jejunum transfer for postoperative swallowing function in patients with total pharyngo-laryngo-cervical-esophagectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
6 month non-swallowing dysfunction rate
Key secondary outcomes
postoperative complication rate
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Free jejunum transfer with cranio-caudaly tensile strength
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Ptients with hypopharyngeal cancer or cervical esophageal cancer
2)Patients undergoing total pharyngolaryngo cervical esophagotomy
3)Patients with Squamouse Cell Carcinoma
4)Patients without distant metastasis
5)Patients that an operation under the general anesthesia is possible
6)Patients with age 20 or more
7)Patients with performance status of 0,1
8)Patients who have submitted written informed consent
Key exclusion criteria
1)Patients with a history of esophagectomy or gastrectomy
2)Patients with excessive resection beyond the superior margin of tonsile
3)Ptients with resection of thoracic esophagus
4)Ptients with active cancer
5)Patients with severe or complicated medical conditions
6)Patients with psychiatric diseases
7)Patients who are not able to have written informed consent
8)Patients considered as inappropriate by their doctors
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Sakuraba |
Organization
National Cancer Center Hospital East
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
6-5-1Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL
04-7133-1111
msakurab@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Higashino |
Organization
National Cancer Center Hospital East
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
6-5-1Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL
04-7133-1111
Homepage URL
takhigas@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East, Department of Plastic and Reconstructive Surgery
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Research and Development Fund23-A-26
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
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
1.国立がん研究センター東病院（千葉県）National Cancer Center Hospital East, Chiba
2.国立がん研究センター中央病院（東京都）National Cancer Center Hospital East,Tokyo
3.九州大学（福岡県）Kyushu University, Fukuoka
4.東京医科歯科大学（東京簿）Tokyo Medical and Dental University, Tokyo
5.東京大学（東京都）Graduate Schill of Medicine, University of Tokyo, Tokyo
6.岡山大学（岡山県）Graduate Schill of Medicine, Okayama University, Okayama
7.神戸大学（兵庫県）Graduate Schill of Medicine, Kobe University, Hyogo
8.愛知県がんセンター（愛知県）Aichi Cancer Center, Aichi
9.杏林大学（東京都）Kyorin University School of Medicien, Tokyo
10.東京慈恵医大（東京都）Jikei University School of Medicien, Tokyo
11.宮城県がんセンター（宮城県）Miyagi Cancer Center, Miyagi
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 10 | 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
| 2012 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 12 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 13 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 13 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 10 | Day |
Last modified on
| 2017 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010770
