UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030549 |
|---|---|
| Receipt number | R000034868 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2017/12/29 |
| Last modified on | 2017/12/24 23:22:13 |
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Basic information
Public title
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
Acronym
Self-expanding metallic stents placement as a bridge to surgery for malignant colorectal obstruction compared to emergency surgery
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yusuke Yagawa |
Organization
Showa University Northern Yokohama Hospital
Division name
digestive disease center
Zip code
Address
Chigasaki-chuo 35-1, Tsuzuki-ku Yokohama-shi, Kanagawa-ken
TEL
045-949-7000
yagawayusuke@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Yagawa |
Organization
Showa University Northern Yokohama Hospital
Division name
digestive disease center
Zip code
Address
Chigasaki-chuo 35-1, Tsuzuki-ku Yokohama-shi, Kanagawa-ken
TEL
090-3089-5484
Homepage URL
yagawayusuke@yahoo.co.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 11 | Month | 21 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034868
