UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063504 |
|---|---|
| Receipt number | R000072682 |
| Scientific Title | Metal stent Angle and Geometry Assessment regarding Risk of Intervention (MAGARI study): Multicenter prospective study |
| Date of disclosure of the study information | 2026/11/03 |
| Last modified on | 2026/11/03 04:41:43 |
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Basic information
Public title
A study of metal biliary stent bending and outcomes in patients with unresectable pancreatic cancer
Acronym
MAGARI study
Scientific Title
Metal stent Angle and Geometry Assessment regarding Risk of Intervention (MAGARI study): Multicenter prospective study
Scientific Title:Acronym
MAGARI study
Region
| Japan |
Condition
Condition
Distal biliary stricture due to unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate, across multiple centers, the associations of stent flexion angle and expansion rate measured on immediate post-placement fluoroscopic images at the optimal projection angle with stent-related and ERCP-related events in patients receiving a Hook & Cross metal stent for distal biliary stricture due to unresectable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between stent flexion angle and the incidence of stent-related and ERCP-related events at 12 months after stent placement.
Key secondary outcomes
1. Association of early adverse events, particularly cholecystitis and pancreatitis, with stent flexion angle
2. Associations of stent migration with expansion rate and stent flexion angle
3. Association of stent kinking with stent flexion angle
4. Stent patency duration
5. Clinical success rate, defined as improvement of jaundice within 14 days 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Distal biliary stricture due to unresectable pancreatic cancer, either locally advanced or metastatic, with the proximal margin of the stricture at least 20 mm distal to the confluence of the right and left hepatic ducts on CT.
2. Indication for endoscopic biliary drainage for obstructive jaundice or cholangitis.
3. Planned use of the target metal stent as determined by the treating physician in routine clinical practice.
4. Age 20 years or older and performance status of 0-2.
Key exclusion criteria
1. Difficulty with endoscopic access because of duodenal stenosis.
2. Previous placement of a metal stent at the target site.
3. Severe organ dysfunction considered by the investigator to make participation inappropriate.
4. Difficulty obtaining consent for study participation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamao |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2602
yamao.kentaro.j0@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamao |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2602
Homepage URL
yamao.kentaro.j0@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Nagoya University Institutional Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-744-2479
ethics@med.nagoya-u.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
名古屋大学医学部附属病院（愛知県）、安城更生病院（愛知県）、一宮市立市民病院（愛知県）、稲沢市民病院（愛知県）、大垣市民病院（岐阜県）、岡崎市民病院（愛知県）、海南病院（愛知県）、関西医科大学附属病院（大阪府）、久留米大学病院（福岡県）、江南厚生病院（愛知県）、公立陶生病院（愛知県）、公立西知多総合病院（愛知県）、市立四日市病院（三重県）、大同病院（愛知県）、知多半島総合医療センター（愛知県）、富山大学病院（富山県）、豊田厚生病院（愛知県）、豊橋市民病院（愛知県）、獨協医科大学（栃木県）、日本赤十字社愛知医療センター名古屋第一病院（愛知県）、東京医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multicenter prospective observational study includes patients with distal biliary stricture due to unresectable pancreatic cancer who are scheduled to receive a Hook & Cross metal stent (J-Metal/ARISTENT, 8-mm diameter) in routine clinical practice and provide written informed consent. No treatment is assigned for research purposes. Immediately after placement, the C-arm is rotated to obtain a fluoroscopic image at the projection showing the sharpest stent bend. Each site measures the obtuse angle between two axes defined by the midpoint of the markers at each stent end and a point 15 mm along the centerline from that end, using its own PACS or image analysis software. A straight stent corresponds to 180 degrees. Expansion rate, routine clinical outcomes, and adverse events are recorded. Preoperative MRCP bile duct angulation is optional and collected only when MRCP has been performed. De-identified clinical data and locally measured numerical imaging data are entered into UMIN INDICE cloud using study IDs. No central image measurement is performed. The primary analysis compares event incidence between two groups divided by the median stent flexion angle. Exploratory analyses include tertile-based comparisons, multivariable logistic regression, and Kaplan-Meier and log-rank analyses of stent patency.
Management information
Registered date
| 2026 | Year | 11 | Month | 03 | Day |
Last modified on
| 2026 | 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=R000072682
