UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery.
Acronym	WING DRAIN Study
Scientific Title	Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery.
Scientific Title:Acronym	WING DRAIN Study
Region	Japan

Condition
Condition	Rectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	WING DRAIN Study is a phase 2 trial to evaluate the safety and efficacy of a novel transanal tube:WING DRAIN for the prevention of anastomotic leakage after low anterior resection surgery for rectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Symptomatic leakage rate
Key secondary outcomes	Symptomatic leakage rate and Radiological leakage rate Complication rate connected with WING DRAIN

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	Central registration

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	We placed transanal tube:WING DRAIN at low anterior resection surgery, and removed it at 4 or 5 postoperative days.
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. Rectal cancer is located at within 10cm above the anal verge 2. Histologically proven rectal adenocarcinoma on biopsy 3. Initial operation for rectal cancer excluding local excision 4. The patients undergoing low anterior resection with mechanical anastomosis 5. The patients have no ileus preoperatively. 6. Organ function is preserved 7. Patient with ECOG performance status of 0, 1, or 2 8. Written informed consent to participation in this trial
Key exclusion criteria	1. Emergency operation 2. Other conditions judged ineligible by physician
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Masaaki Middle name Last name Ito
Organization	National Cancer Center Hospital East
Division name	Colorectal Surgery
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
TEL	+81-4-7133-1111
Email	maito@east.ncc.go.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Nishizawa
Organization	National Cancer Center Hospital East
Division name	Colorectal Surgery
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
TEL	+81-4-7133-1111
Homepage URL
Email	yunishiz@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Muranaka Medical Instruments.CO. LTD.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Cancer Center Hospital Tokyo Metropolitan Cnncer and Infectious Diseases Center Komagome Hospital Iwate Medical University School of Medicine Kitasato University School of Medicine Shizuoka Cancer Center
Name of secondary funder(s)	Muranaka Medical Instruments.CO. LTD.

IRB Contact (For public release)
Organization	National Cancer Center Hospital East
Address	6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
Tel	04-7133-1111
Email	yunishiz@east.ncc.go.jp

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	2017 Year 07 Month 01 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	2017 Year 06 Month 16 Day
Date of IRB	2017 Year 06 Month 27 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2019 Year 01 Month 20 Day
Date of closure to data entry	2019 Year 02 Month 01 Day
Date trial data considered complete	2019 Year 02 Month 01 Day
Date analysis concluded	2019 Year 03 Month 12 Day

Other
Other related information

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2019 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031452

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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