UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Self-expanding metallic stents placement as a bridge to surgery for malignant colorectal obstruction compared to emergency surgery: a clinical result from a Japanese referral center
Title of the study (Brief title)	Self-expanding metallic stents placement as a bridge to surgery for malignant colorectal obstruction compared to emergency surgery
Region	Japan

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

Objectives
Narrative objectives1	This retrospective study aimed to evaluate the short-term and long-term outcomes of self-expanding metal stents (SEMS) placement for malignant colorectal obstruction as a bridge in comparison with those of emergency surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	relapse-free survival
Key secondary outcomes	primary anastomosis stoma formation laparoscopic surgery lymph node dissection complications 30-day mortality

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	The subjects were patients with acute malignant colorectal obstruction who were treated by either elective surgery after SEMS placement or emergency surgery between April 2001 and June 2016 at Showa University Northern Yokohama Hospital.
Key exclusion criteria	Patients with decompression by nasal ileus tube or trans-anal tube as the first treatment, and a patient with signs of peritonitis by perforation were excluded from this study.
Target sample size	60

Research contact person
Name of lead principal investigator	Yusuke Yagawa
Organization	Showa University Northern Yokohama Hospital
Division name	digestive disease center
Address	Chigasaki-chuo 35-1, Tsuzuki-ku Yokohama-shi, Kanagawa-ken
TEL	045-949-7000
Email	yagawayusuke@yahoo.co.jp

Public contact
Name of contact person	Yusuke Yagawa
Organization	Showa University Northern Yokohama Hospital
Division name	digestive disease center
Address	Chigasaki-chuo 35-1, Tsuzuki-ku Yokohama-shi, Kanagawa-ken
TEL	090-3089-5484
Homepage URL
Email	yagawayusuke@yahoo.co.jp

Sponsor
Institute	Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	Showa University Northern Yokohama Hospital
Organization
Division
Category of Funding Organization	Self funding
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	昭和大学横浜市北部病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 29 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 21 Day
Anticipated trial start date	2017 Year 11 Month 24 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This is a single institution retrospective study. Data regarding the treatment method, age, sex, location, pStage of tumor, treatment outcomes related to SEMS placement, treatment outcomes related to surgery, recurrence rate, and follow-up period were collected from the hospital records.

Management information
Registered date	2017 Year 12 Month 24 Day
Last modified on	2017 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034868