UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effectiveness of stenting for obstructive colorectal cancer at Niigata City Hospital
Acronym	Study of stenting for obstructive colorectal cancer
Scientific Title	Comparison of the oncological outcomes of stenting as a bridge to surgery and surgery alone in obstructive colorectal cancer; a retrospective study
Scientific Title:Acronym	Comparison stenting as a bridge to surgery and surgery alone in obstructive colorectal cancer
Region	Japan

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

Objectives
Narrative objectives1	We evaluated the oncological outcomes of bridge to surgery (BTS) using a self-expanded metallic stent (SEMS) compared with surgery alone for obstructive colorectal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative recurrence rate through 8 years after introduction of colorectal stent at Niigata City General Hospital.
Key secondary outcomes	the short-term surgical outcome, survival rate, recurrence sites.

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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who underwent curative resection for obstructive colorectal cancer at Niigata City General Hospital were divided into the bridge to surgery with stenting group (treated from April 2012, when stenting for malignant bowel obstruction was covered by insurance in Japan, to 2019) and the surgery alone group (treated from 2008 to 2019). The surgery alone group included patients who did not undergo decompression and patients who underwent non-surgical bowel decompression at the oral side of obstructive colorectal cancer and had a nasal ileus tube or nasogastric tube placed before curative resection. In this study, obstructive colorectal cancer was diagnosed by computed tomography (CT) and colonoscopy in which urgent decompression was deemed necessary.
Key exclusion criteria	The patients who underwent preoperative bowel decompression procedures by trans-anal tube or stoma creation at the oral side of the cancer were excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Uehara
Organization	Niigata City General Hospital
Division name	Department of Digestive Surgery
Zip code	950-1197
Address	463-7, Shumoku, Chuo-ku, Niigata City, Niigata, Japan.
TEL	+81-25-281-5151
Email	hiroaki.u@hotmail.co.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Uehara
Organization	Niigata City General Hospital
Division name	Department of Digestive Surgery
Zip code	950-1197
Address	463-7, Shumoku, Chuo-ku, Niigata City, Niigata, Japan.
TEL	+81-25-281-5151
Homepage URL
Email	hiroaki.u@hotmail.co.jp

Sponsor
Institute	Niigata City General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Niigata City General Hospital
Address	463-7, Shumoku, Chuo-ku, Niigata City, Niigata, Japan.
Tel	+81-25-281-5151
Email	hiroaki.u@hotmail.co.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	2020 Year 06 Month 15 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	85
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	Completed
Date of protocol fixation	2020 Year 04 Month 19 Day
Date of IRB	2020 Year 04 Month 20 Day
Anticipated trial start date	2020 Year 04 Month 20 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 06 Month 15 Day
Last modified on	2020 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046558