UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011855 |
|---|---|
| Receipt number | R000013810 |
| Scientific Title | Biliary partially-covered Wallflex for bridge to surgery in patients with pancreatic cancer receiving neo-adjuvant chemotherapy |
| Date of disclosure of the study information | 2013/09/25 |
| Last modified on | 2017/05/31 18:33:20 |
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Basic information
Public title
Biliary partially-covered Wallflex for bridge to surgery in patients with
pancreatic cancer receiving neo-adjuvant chemotherapy
Acronym
BTS-NAC study
Scientific Title
Biliary partially-covered Wallflex for bridge to surgery in patients with
pancreatic cancer receiving neo-adjuvant chemotherapy
Scientific Title:Acronym
BTS-NAC study
Region
| Japan |
Condition
Condition
resectable or borderline resectable pancreatic cancer undergoing neo-adjuvant chemotherapy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of preoperative biliary drainage with partially-covered SEMS in patients uwith resectable or borderline resectable pancreatic cancer undergoing neoadjuvant chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of recurrent biliary obstruction prior to surgery
Key secondary outcomes
Time to recurrent biliary obstruction (TRBO), adverse events, overall survival, stent removal at the time of surgery.
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) Biliary drainage using a paritially-covered SEMS
2) Scheduled for neoadjuvant chemotherapy or chemoradiotherapy
3) Distal malignant biliary obstruction due to pancreatic cancer
4) Age 20 or older
5) Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Key exclusion criteria
1) Location of distal biliary obstruction such that it would not allow the proximal end of a stent to be positioned at least 2 cm from the hilum
2) Patients with duodenal obstruction anal to the ampulla
3) Tumor involvement to the orifice of cystic duct
4) Previous biliary drainage by ENBD or EBD more than 2 weeks
5) Patients with severely impaired organ function
6) Patients for whom endoscopic biliary drainage is difficult
7) Patients with distant metastasis
8) Hilar biliary obstruction
9) Without pathological diagnosis
10) Patients considered ineligible for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
The University of Tokyo
Division name
Gastroenterology
Zip code
Address
7-3-1, Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
isayama-2im@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Saito |
Organization
The University of Tokyo
Division name
Gastroenterology
Zip code
Address
7-3-1, Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
Homepage URL
saitoke-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京大学医学部附属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 25 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2013 | Year | 09 | Month | 24 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013810
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
