UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050406 |
|---|---|
| Receipt number | R000057231 |
| Scientific Title | Assessment of risk factors for recurrent biliary obstruction following palliative endoscopic biliary stenting in patients with unresectable ampullary cancer: a multicenter retrospective study |
| Date of disclosure of the study information | 2023/02/28 |
| Last modified on | 2024/06/25 13:12:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of risk factors for recurrent biliary obstruction following palliative endoscopic biliary stenting in patients with unresectable ampullary cancer: a multicenter retrospective study
Acronym
Assessment of risk factors for recurrent biliary obstruction following palliative endoscopic biliary stenting in patients with unresectable ampullary cancer: a multicenter retrospective study
Scientific Title
Assessment of risk factors for recurrent biliary obstruction following palliative endoscopic biliary stenting in patients with unresectable ampullary cancer: a multicenter retrospective study
Scientific Title:Acronym
Assessment of risk factors for recurrent biliary obstruction following palliative endoscopic biliary stenting in patients with unresectable ampullary cancer: a multicenter retrospective study
Region
| Japan |
Condition
Condition
Unresectable ampullary cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify risk factors for recurrent biliary obstruction following palliative endoscopic biliary stenting in patients with unresectable ampullary cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors for recurrent biliary obstruction (RBO) following palliative endoscopic biliary stenting
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
1) patients who were diagnosed of ampullary cancer by pathological analyses
2) patients who underwent endoscopic biliary stenting
3) patient's or their families' agreement to enrollment in this study by the opt-out form
Key exclusion criteria
1) patients who underwent curative surgery
2) patients who underwent endoscopic papillectomy
3) patients who underwent endoscopic ultrasound-guided biliary drainage until the initial endoscopic biliary stenting
4) patients who underwent insertion of multiple stents
5) patients with biliary obstruction due to metastatic malignancy
6) refusal for enrollment in this study by the patients or their families
Target sample size
107
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo, Japan
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Sugiura |
Organization
Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
rsugiura-hok@umin.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Gastroenterological Endoscopy Society Hokkaido Chapter
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/1751-2980.13288
Number of participants that the trial has enrolled
107
Results
The study analysis comprised a total of 107 patients with a median age of 84 years (IQR, 79-88). A plastic stent (PS) or a self-expandable metal stent (SEMS) was placed in 53 and 54 patients, respectively. Recurrent biliary obstruction (RBO) occurred in 62 patients (59.6%). The median time to RBO was 190 days. Multivariate analysis showed that the use of a PS and the presence of bile duct stones/sludge were independent risk factors for RBO (hazard ratio=2.48 and 1.99, respectively).
Results date posted
| 2024 | Year | 06 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 06 | Month | 20 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective observational study
Management information
Registered date
| 2023 | Year | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057231
