UMIN-CTR Clinical Trial

Basic information
Public title	A study on colonic decompression as bridge to surgery for stageII/III obstructive colon cancer; retrospective multicenter observational study
Acronym	A study on colonic decompression as bridge to surgery for stageII/III obstructive colon cancer; retrospective multicenter observational study
Scientific Title	A study on colonic decompression as bridge to surgery for stageII/III obstructive colon cancer; retrospective multicenter observational study
Scientific Title:Acronym	A study on colonic decompression as bridge to surgery for stageII/III obstructive colon cancer; retrospective multicenter observational study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate clinical significance of colonic stenting for obstructive left-sided colon cancer retrospectively in stage II and III colon cancer patients for whom colonic depression were requied.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	3-year progression free survival
Key secondary outcomes	The frequency of adverse events during colonic depression. Postoperative complications. The length of a hospital stay after surgey. The induction rate of postoperative adjuvant chemotherapy. Second surgery for synchronous colon cancer. Pattern of recurrence.

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients who underwent curative surgery for obstructive left-sided colon cancer with fstage II and III from January, 2010 to June, 2014. (2) Patients with histologically confirmed primary colorectal cancer. (3) Aged 20 to 80 years (4) Tumor location; Descending colon (D), Sigmoid colon (S), Rectosigmoid colon (RS), and Upper part of rectum (Ra). (5) ColoRectal Obstruction Scoring System (CROSS) 0 or 1. Patients requiring continuous decompressive procedure or patients with no oral intake.
Key exclusion criteria	(1) Patients preoperatively treated with chemotherapy and/or radiotherapy. (2) ECOG Performance status of 3. (3) Active multiple malignancy
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Shungo Middle name Last name Endo
Organization	Aizu Medical Center, Fukushima Medical University
Division name	Department of Coloproctology
Zip code	969-3492
Address	21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima, 969-3492, Japan
TEL	0242-75-2100
Email	endoswing@gmail.com

Public contact
Name of contact person	1st name Shungo Middle name Last name Endo
Organization	Aizu Medical Center, Fukushima Medical University
Division name	Department of Coloproctology
Zip code	969-3492
Address	21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima, 969-3492, Japan
TEL	0242-75-2100
Homepage URL
Email	endoswing@gmail.com

Sponsor
Institute	Japan Colonic Stent Safe Procedure Research Group
Institute
Department

Funding Source
Organization	Japan Colonic Stent Safe Procedure Research Group
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	Fukushima Medical University
Address	1 Hikarigaoka, Fukushima-shi, Fukushima
Tel	024-547-1825
Email	rs@fmu.ac.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	2016 Year 11 Month 07 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/33247313/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/33247313/
Number of participants that the trial has enrolled	301
Results	The 3-year relapse-free survival rate in patients in the Surgery group was 74.8%, while that in patients in the SEMS group and TADT group were 69.0% (p？=？0.39) and 55.3% (p？=？0.006), respectively. The technical success rate was not statistically different, but the clinical success rate was significantly higher in the SEMS group than in the TADT group (p？=？0.0040).
Results date posted	2021 Year 04 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The subjects were patients with histologically proven stage II/III left-sided colon or upper rectal cancer with obstruction, who underwent subsequent surgery with curative resection between January 2010 and December 2014.
Participant flow	NA
Adverse events	NA
Outcome measures	The 3-year RFS
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 30 Day
Date of IRB	2016 Year 08 Month 30 Day
Anticipated trial start date	2016 Year 11 Month 07 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective study

Management information
Registered date	2016 Year 10 Month 19 Day
Last modified on	2021 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028164