UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048867 |
|---|---|
| Receipt number | R000055310 |
| Scientific Title | Randomized controlled trial of 10-Fr plastic stent versus 6-mm diameter covered self-expandable metallic stent for preoperative biliary drainage in patient receiving neo-adjuvant chemotherapy for resectable and borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2022/09/07 |
| Last modified on | 2024/06/21 07:44:00 |
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Basic information
Public title
Randomized controlled trial of 10-Fr plastic stent versus 6-mm diameter covered self-expandable metallic stent for preoperative biliary drainage in patient receiving neo-adjuvant chemotherapy for resectable and borderline resectable pancreatic cancer
Acronym
PS versus CSEMS for resectable and borderline resectable pancreatic cancer
Scientific Title
Randomized controlled trial of 10-Fr plastic stent versus 6-mm diameter covered self-expandable metallic stent for preoperative biliary drainage in patient receiving neo-adjuvant chemotherapy for resectable and borderline resectable pancreatic cancer
Scientific Title:Acronym
PS versus CSEMS for resectable and borderline resectable pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of 10-Fr plastic stent versus 6-mm diameter covered self-expandable metallic stent in patients with resectable pancreatic cancer or borderline-resectable pancreatic cancer with portal vein contact who had distal malignant biliary obstruction and were scheduled to receive preoperative neoadjuvant therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of recurrent biliary obstruction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Interventions is to place a 6-mm diameter covered self-expandable metallic stent for malignant distal biliary obstruction
Interventions/Control_2
Control is to place a 10-Fr plastic stent for malignant distal biliary obstruction
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
1) patients =or >18 years of age
2) pathological diagnosed invasive ductal carcinomas
3) ECOG performance status 0 or 1
4) diagnosed resectable pancreatic cancer or borderline-resectable pancreatic cancer with portal vein contact
5) schedueled for neoadjvant therapy
6) malignant distal biliary obstruction
7) providing written informed consent
Key exclusion criteria
1) diagnosed bordeline-resectable panvreatic cancer with arterial contact
2) previous biliary drainage with metallic stent
3) under 2cm from hilar bile duct to obstruction
4) with Gastric outlet obstruction
5) after gastric surgery (excluding Billroth-I)
6) history of metal allergy
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
TEL
+81427788111
kokuwaki@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
TEL
+81427788111
Homepage URL
m.wata@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
Department of Gastroenterology
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
Kitasato University Ethics Committee
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
Tel
+81427788111
rinrib@med.kitasato-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
北里大学病院（神奈川県）
北里大学メディカルセンター（埼玉県）
伊勢原協同病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 07 | 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
| 2022 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055310
