UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041704 |
|---|---|
| Receipt number | R000047585 |
| Scientific Title | Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent |
| Date of disclosure of the study information | 2020/09/07 |
| Last modified on | 2022/12/29 23:06:14 |
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Basic information
Public title
Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent
Acronym
Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent
Scientific Title
Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent
Scientific Title:Acronym
Phase 2 study of endoscopic trans papillary biliary drainage for distal biliary stricture of pancreatic cancer during preoperative chemotherapy with 6mm diameter Fully covered self-expandable metal stent
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the clinical safety and efficacy of 6mm diameter Fully covered self-expandable metallic stent (FCSEMS) in endoscopic biliary drainage for obstructive jaundice during preoperative chemotherapy for pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Stent-related complications (pancreatitis, non-occlusion cholangitis, cholecystitis, bleeding, perforation)
Key secondary outcomes
Non biliary obstruction rates of per resectable and borderline pancreatic cancer.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
New therapy: Endoscopic Biliary Drainage by 6mm diameter fully covered self-expandable metallic stent.
Observation period: 30days after surgery from the date of stent deployment or the date of the decision not to resect the pancreatic cancer.
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
| 79 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age at the date of registration is between 20 and 79 years.
2) Pancreatic cancer has been diagnosed by imaging or cytology/histology.
3) Resectable or Borderline resectable pancreatic cancer has been determined by contrast-enhanced CT or contrast-enhanced MRI, with neoadjuvant chemotherapy planned.
4) The patient with distal bile duct stenosis by pancreatic cancer needs biliary drainage*.
T-Bil>1.5mg/dL, AST>100U/L or ALT>100U/L.
5) No endoscopic transpapilary biliary drainage with plastic stent, Endoscopic nasobiliary drainage, or FCSEMS was performed.
*Int patients with a history of percutaneous biliary drainage, the patient was eligible if 5) was met.
6) Major organ functions are preserved.
7) Performance status is kept at 0 and 1.
8) Written informed consent.
Key exclusion criteria
1) The patient has acute cholangitis.
2) Duodenal stenosis is suspected on specific symptoms or imaging studies.
3) The physician determines that the patient's enrollment in the study is inappropriate.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | okusaka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology Division
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL
03-3542-2511
tokusaka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Harai |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology Division
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
shotaharai02@gmail.com
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
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
National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
Tel
03-3542-2511
shotaharai02@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
| 2020 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 07 | Day |
Last modified on
| 2022 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047585
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