UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for standardization of operative method of free jejunum transfer
Title of the study (Brief title)	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	Minoru Sakuraba
Organization	National Cancer Center Hospital East
Division name	Department of Plastic and Reconstructive Surgery
Address	6-5-1Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL	04-7133-1111
Email	msakurab@east.ncc.go.jp

Public contact
Name of contact person	Takuya Higashino
Organization	National Cancer Center Hospital East
Division name	Department of Plastic and Reconstructive Surgery
Address	6-5-1Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL	04-7133-1111
Homepage URL
Email	takhigas@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East, Department of Plastic and Reconstructive Surgery
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 04 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010770