UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061800 |
|---|---|
| Receipt number | R000070712 |
| Scientific Title | A single-center prospective observational study evaluating the usefulness of gel immersion endoscopy in difficult colorectal stent placement for obstructive colorectal cancer |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/06/04 18:40:14 |
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Basic information
Public title
Prospective observational study evaluating the usefulness of gel immersion endoscopy for difficult colorectal stent placement in patients with obstructive colorectal cancer
Acronym
Gel Immersion for Stent placement in Colorectal Obstruction
Scientific Title
A single-center prospective observational study evaluating the usefulness of gel immersion endoscopy in difficult colorectal stent placement for obstructive colorectal cancer
Scientific Title:Acronym
GISCO Study
Region
| Japan |
Condition
Condition
Obstructive colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the efficacy and safety of gel immersion endoscopy (GIE) in patients with obstructive colorectal cancer undergoing difficult colorectal stent placement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from initiation of guidewire insertion to successful guidewire and catheter passage through the stenotic lesion (seconds), assessed during colorectal stent placement.
Key secondary outcomes
1.Success rate of guidewire and catheter passage through the stenotic lesion, assessed during the procedure
2.Technical success rate, assessed at completion of stent placement
3.Clinical success rate, assessed within 1 week after stent placement
4.Total procedure time, assessed at completion of the procedure
5.Volume of Viscoclear used during gel immersion endoscopy, assessed at completion of the procedure
6.Adverse event rate including perforation, bleeding, stent migration, and stent occlusion, assessed within 1 week after stent placement
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
1.Patients scheduled for colorectal stent placement for malignant colorectal obstruction.
2.Patients who provide written informed consent, or whose legal representative provides consent.
Key exclusion criteria
1.Patients with suspected benign colorectal stenosis.
2.Patients with suspected gastrointestinal perforation.
3.Patients with multiple colorectal stenotic lesions.
4.Patients whose general condition precludes endoscopic intervention.
5.Patients considered unsuitable by the investigators.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tamura |
Organization
Iwata City Hospital
Division name
Department of Gastroenterology
Zip code
438-8550
Address
512-3 Okubo, Iwata, Shizuoka 438-8550, Japan
TEL
0538-38-5000
nva.tamta@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Ikeda |
Organization
Iwata City Hospital
Division name
Department of Gastroenterology
Zip code
438-8550
Address
512-3 Okubo, Iwata, Shizuoka 438-8550, Japan
TEL
0538-38-5000
Homepage URL
hp_nsxx0303@yahoo.co.jp
Sponsor or person
Institute
Iwata City Hospital
Institute
Department
Personal name
Shinya Ikeda
Funding Source
Organization
Iwata City Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwata City Hospital
Address
512-3 Okubo, Iwata, Shizuoka 438-8550, Japan
Tel
0538-38-5000
hp_nsxx0303@yahoo.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
静岡県
Institutions
Institutions
磐田市立総合病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 08 | 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
| 2026 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study evaluating the efficacy and safety of gel immersion endoscopy (GIE) in difficult colorectal stent placement for obstructive colorectal cancer. GIE is performed when standard guidewire passage is difficult, and procedural outcomes are prospectively collected. Comparative analyses with historical control cases treated between April 2023 and March 2026 are planned.
Management information
Registered date
| 2026 | Year | 06 | Month | 04 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070712
