UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063085 |
|---|---|
| Receipt number | R000066918 |
| Scientific Title | The Usefulness of Gel Immersion Endoscopy in Patients with Pancreaticojejunostomy Anastomotic Stricture: A Multicenter Prospective Observational Study |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 20:46:15 |
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Basic information
Public title
The Usefulness of Gel Immersion Endoscopy in Patients with Pancreaticojejunostomy Anastomotic Stricture: A Multicenter Prospective Observational Study
Acronym
Gel Immersion Endoscopy in Patients with Pancreaticojejunostomy Anastomotic Stricture
Scientific Title
The Usefulness of Gel Immersion Endoscopy in Patients with Pancreaticojejunostomy Anastomotic Stricture: A Multicenter Prospective Observational Study
Scientific Title:Acronym
Gel Immersion Endoscopy in Patients with Pancreaticojejunostomy Anastomotic Stricture
Region
| Japan |
Condition
Condition
Pancreaticojejunostomy anastomotic stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pancreaticojejunostomy anastomotic stricture (PJAS) is a late complication that can occur after pancreaticoduodenectomy and may lead to symptoms such as pancreatitis. Endoscopic treatment is often attempted via the anastomosis, but identifying the site can be challenging, and success rates are relatively low. Gel immersion endoscopy (GIE) has recently been introduced to improve visibility during endoscopic procedures. This technique has shown promise in enhancing the identification of the anastomosis site. However, its effectiveness in PJAS has not been evaluated in a prospective study. This multicenter prospective observational study aims to assess the usefulness of GIE during endoscopic treatment for PJAS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Added Benefit of Gel Immersion Endoscopy for Successful Identification of the Pancreaticojejunostomy Anastomosis
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria
1) Symptomatic PJAS after pancreaticoduodenectomy (PD)
2) Age 20 years or older
3) Provided with sufficient explanation about the study and obtained written informed consent from the patient
Key exclusion criteria
Exclusion Criteria
1) History of treatment for PJAS
2) Pregnant or suspected pregnancy
3) Any other condition judged inappropriate for participation by the principal investigator or sub-investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kaneko |
Organization
Iwata City Hospital
Division name
Department of Gastroenterology
Zip code
438-8550
Address
521, Ookubo, Iwata-shi, Shizuoka, Japan
TEL
0538-38-5000
meganerock10@gmail.com
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Kaneko |
Organization
Iwata City Hospital
Division name
Department of Gastroenterology
Zip code
438-8550
Address
521, Ookubo, Iwata-shi, Shizuoka, Japan
TEL
0538-38-5000
Homepage URL
meganerock10@gmail.com
Sponsor or person
Institute
Iwata City Hospital
Institute
Department
Personal name
Funding Source
Organization
NA
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
Iwata City Hospital
Address
521, Ookubo, Iwata-shi, Shizuoka, Japan
Tel
0538-38-5000
meganerock10@gmail.com
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
| 2026 | Year | 09 | Month | 28 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066918
