UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056032 |
|---|---|
| Receipt number | R000064033 |
| Scientific Title | Prospective Feasibility Study of Using the EG-840TP Scope, a Novel Thin Scope for Gastrointestinal Therapeutic Procedures for Stent Placement in Colonic Cancer Obstruction |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2025/11/03 16:29:29 |
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Basic information
Public title
Prospective Feasibility Study of Using the EG-840TP Scope, a Novel Thin Scope for Gastrointestinal Therapeutic Procedures for Stent Placement in Colonic Cancer Obstruction
Acronym
Study on Colonic Stent Placement Using a Novel Thin Scope
Scientific Title
Prospective Feasibility Study of Using the EG-840TP Scope, a Novel Thin Scope for Gastrointestinal Therapeutic Procedures for Stent Placement in Colonic Cancer Obstruction
Scientific Title:Acronym
Study on EG-840TP-Colonic Stent Placement
Region
| Japan |
Condition
Condition
Colonic cancer obstruction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the EG-840TP for stent placement in colonic cancer obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success rate of colonic stent placement.
Key secondary outcomes
Clinical success rate of colonic stent placement, DVS success rate, presence of early complications, scope exchange rate, stricture length, placement method (DVS, TTS), procedure time, and fluoroscopy time.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with malignant colonic stricture due to rectal or sigmoid colon cancer.
Patients with colonic cancer obstruction confirmed by CT or X-ray imaging, scheduled for stent placement.
Patients over 18 years old.
Patients who have given their consent to participate in the study on paper.
Key exclusion criteria
Pregnant patients.
Patients deemed inappropriate by the attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yosei |
| Middle name | |
| Last name | Sawai |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1, Tsurugaya, Miyagino-ku Sendai-shi, Miyagi-ken, Japan
TEL
0222521111
yosei.sawai@openhp.or.jp
Public contact
Name of contact person
| 1st name | Yosei |
| Middle name | |
| Last name | Sawai |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1, Tsurugaya, Miyagino-ku Sendai-shi, Miyagi-ken, Japan
TEL
08020779483
Homepage URL
yosei.sawai@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendai City Medical Center
Address
5-22-1, Tsurugaya, Miyagino-ku Sendai-shi, Miyagi-ken, Japan
Tel
0222521111
yosei.sawai@openhp.or.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
| 2024 | Year | 11 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Endoscopic stent placement is performed according to the following procedure.
The EG-840TP scope is used, with no restriction on the type or specifications of the stent.
Upon reaching the stricture, the length of the stricture is measured to select an appropriately sized stent, as follows.
If the scope can pass through the stricture, the scope is withdrawn from the oral side to the anal side of the stricture, and the length of the withdrawn scope is measured using the scope's scale.
If passage is not possible, a guidewire is passed through the stricture, and a catheter is inserted along the guidewire to the oral side of the stricture. The catheter is then withdrawn to the anal side under fluoroscopic guidance, allowing measurement of the stricture length.
If the scope can pass through the stricture, the stent is placed via the Direct-Vision Stenting (DVS) method whenever possible.
DVS Method. 1, Insert the scope on the oral side of the stricture. 2, With the scope positioned at the oral side of the stricture, deploy the stent under direct visualization by 1-2 cm. 3, Withdraw the scope to the oral edge of the stricture, fixing the stent within the stricture. 4, Deploy the stent within the channel. 5, Withdraw the scope while pushing the delivery system forward to complete stent placement. Use of X-ray or guidewire is permitted if needed, but in principle, the procedure is performed under direct visualization from the beginning of stent deployment to full expansion.
If the scope cannot pass through the stricture, advance the guidewire to the oral side of the stricture under fluoroscopy. The stent is then placed using the standard Through-the-scope (TTS) method or within-the scope channel (intra-scope channel) stent release technique.
If the scope cannot reach the stricture or if scope use complicates stent placement, the operator may change the scope and endoscopic system at their discretion.
Management information
Registered date
| 2024 | Year | 11 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064033
