UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057141 |
|---|---|
| Receipt number | R000064961 |
| Scientific Title | Prospective Feasibility Study on Direct-vision Stenting using Novel Thin Scope EG-840TP for Malignant Gastric Outlet Obstruction |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2026/04/08 17:43:43 |
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Basic information
Public title
Endoscopic stent placement using EG-840TP scope for malignant gastric outlet obstruction
Acronym
Endoscopic stent placement using EG-840TP scope for malignant gastric outlet obstruction
Scientific Title
Prospective Feasibility Study on Direct-vision Stenting using Novel Thin Scope EG-840TP for Malignant Gastric Outlet Obstruction
Scientific Title:Acronym
Prospective Feasibility Study on Direct-vision Stenting using Novel Thin Scope EG-840TP for Malignant Gastric Outlet Obstruction
Region
| Japan |
Condition
Condition
malignant gastric outlet obstruction
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of endoscopic stent placement for malignant gastric outlet obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical success rate of endoscopic stent placement
Key secondary outcomes
clinical success rate of endoscopic stent placement, technical success rate of endoscopic stent placement with DVS method, early complications, stenotic length, procedure time, dosage of sedative and analgesic drugs, X-ray exposure 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
a. The patient who was diagnosed for malignant gastric outlet obstruction by esophagogastroduodenoscopy or imaging findings, and GOO scoring system score was categolyzed to 2 points and less.
b. The patient who has the stenotic site between pyrolus and deodenum.
c. The patient who are 18 years old and more.
Key exclusion criteria
a. patients who has multiple stenotic sites with gastrointestinal tract.
b. patients with a history of surgery involving gastrointestinal reconstruction
c. patients with a history of endoscopic stent placement for malignant gastric outlet obstruction
d. pregnant patients
e. patients deemed inappropriate by the attending physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Teruyuki |
| Middle name | |
| Last name | Numata |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
983-0824
Address
5-22-1 Tsurugaya, Miyagino, Sendai, Japan
TEL
0222521111
t-numata@openhp.or.jp
Public contact
Name of contact person
| 1st name | Teruyuki |
| Middle name | |
| Last name | Numata |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
9830824
Address
5-22-1 Tsurugaya, Miyagino, Sendai, Japan
TEL
0222521111
Homepage URL
t-numata@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, Sendai, Japan
Tel
0222521111
t-numata@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
| 2025 | Year | 03 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 04 | Month | 20 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the usufulness and safety of endoscopic stent placement for malignant gastric outlet obstruction using EG-840TP scope, we measure the evaluation criteria about the procedure, such as clinical success rate, technical success rate, technical success rate with Direct-Vision-Stenting (DVS) method, early adverse event, stenotic length, hospital stay days, X-ray exposure time, and X-ray exposure dose.
the procedure for endoscopic stent placement is performed according to following steps.
1: If the EG-840TP scope is passed through the stenotic site, you perform stent placement using DVS method as below.
After the scope is advanced into the anal side of stenosis, you inserted the ERCP catheter through the accessory channel. You pull the catheter under fluoroscopy, and measure the stenotic length as an indicator of radiopaque marker. The duodenal stent is partially deployed and secured at the distal side of the stenosis. As the scope was withdrawn, the stent was deployed in channel and the delivery system was pushed out.
2: If the EG-840TP scope cannnot be passed through the stenotic site, you perform stent placement with conventional method such as Through-The-Scope method.
Management information
Registered date
| 2025 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064961
