UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on colonic decompression as bridge to surgery for obstructive colon cancer.
Title of the study (Brief title)	A study on colonic decompression as bridge to surgery for obstructive colon cancer.
Region	Japan

Condition
Condition	obstructive colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the safety and long-term results of surgery (BTS: Bridge to Surgery) after decompression with colon stent for obstructive colon cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Complication rate during decompression and perioperative period.
Key secondary outcomes

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	Primary tumor resection within 3-30 days after stent(Nite-S colonic stent) placement.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Colonic stricture presumed secondary to a carcinoma by preoperative imaging modalities such as abdominal and pelvic CT or colonoscope. 2)Patient with at least one of the following obstructive findings; 1. Intolerable for oral intake or necessary for fasting at the judgement of the attending physician 2. No fart 3. Bloating or abdominal pain 4. Abnormality of defecation such as constipation or frequent diarrhea 5. Nausea or vomiting 3)Written informed consent to participation in this trial
Key exclusion criteria	1)chemotherapy or radiotherapy before primary resection was performed 2)active overlapping cancer affecting the prognostic evaluation 3)Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size	40

Research contact person
Name of lead principal investigator	daisuke nakano
Organization	Tokyo Metropolitan Cancer and infectious diseases center Komagome Hospital
Division name	Surgery
Address	504, 6-12-14, komagome, toshima-ku, Tokyo.
TEL	09034294524
Email	gonchan5@cick.jp

Public contact
Name of contact person	daisuke nakano
Organization	Tokyo Metropolitan Cancer and infectious diseases center Komagome Hospital
Division name	Surgery
Address	504, 6-12-14, komagome, toshima-ku, Tokyo.
TEL	09034294524
Homepage URL
Email	gonchan5@cick.jp

Sponsor
Institute	Tokyo Metropolitan Cancer and infectious diseases center Komagome Hospital
Institute
Department

Funding Source
Organization	tokyo metropolitan government
Organization
Division
Category of Funding Organization	Local Government
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	がん・感染症センター都立駒込病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 28 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 08 Month 28 Day
Last modified on	2018 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038697