UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041737 |
|---|---|
| Receipt number | R000045492 |
| Scientific Title | A randomized controlled trial to verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice |
| Date of disclosure of the study information | 2020/09/09 |
| Last modified on | 2023/09/15 11:48:19 |
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Basic information
Public title
A randomized controlled trial to verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice
Acronym
PCSEMS vs.UCSEMS for during neoadjuvant therapy in pancreatic cancer patients in RCT
Scientific Title
A randomized controlled trial to verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice
Scientific Title:Acronym
PCSEMS vs.UCSEMS for during neoadjuvant therapy in pancreatic cancer patients in RCT
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the non-inferiority of partially covered self-expandable metal stent (PCSEMS) to uncovered self-expandable metal stent (UCSEMS) for biliary drainage during neoadjuvant therapy in pancreatic cancer patients with obstructive jaundice
Basic objectives2
Others
Basic objectives -Others
Non-inferiority
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Biliary event rate until surgery after biliary stenting with a metal stent
Key secondary outcomes
(1) curative resection rate
(2)Time to Recurrent biliary obstruction
(3)Chemotherapy accomplishment/delay/discontinuation
(4)Other stent-related adverse events
(5)Frequency and severity of adverse events after curative surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Uncovered stent
Interventions/Control_2
Partially covered stent
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
Pancreatic cancer patients with jaundice scheduled for neoadjuvant chemo-/chemoradiotherapy:
(1) pathological diagnosis of pancreatic ductal adenocarcinoma/adenosquamous carcinoma; (2) clinical diagnosis of resectable/borderline resectable pancreatic cancer according to the 7th edition of the General Rules for the Study of Pancreatic Cancer by the Japan Pancreas Society, which is almost equal to National Comprehensive Cancer Network (NCCN) Guideline Version 1.2020; (3) scheduled for neoadjuvant chemotherapy/chemoradiotherapy; (4) confirmed distal biliary obstruction (defined as stricture at the common bile duct located downstream of the confluence of the cystic duct according to the Classification of Biliary Tract Cancers established by the Japanese Society of Hepato-Biliary-Pancreatic Surgery: 3rd English edition) requiring endoscopic biliary drainage (or a history of endoscopic/percutaneous transhepatic biliary drainage using a plastic stent/tube), which leads to abnormal serum total bilirubin or liver function test results (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, or alkaline phosphatase values not within normal reference ranges at each institution) with or without bile duct dilatation; (5) being 20 or more years of age and (6) willingness to provide informed consent
Key exclusion criteria
(1) history of biliary drainage with a metal stent; (2) history of chemotherapy/chemoradiotherapy for pancreatic cancer; (3) biliary obstruction that progresses to the hepatic hilum; (4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 4; (5) history of gastrointestinal tract reconstruction except for Billroth I reconstruction; (6) the major duodenal papilla unreachable by a duodenal endoscope; (7) current pregnancy or suspected pregnancy; (8) unsuitable for inclusion at the discretion of the physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Gastroenterology and Hepatology
Zip code
060-8648
Address
West 5, North 14, Kita-ku, Sapporo
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Gastroenterology and Hepatology
Zip code
060-8648
Address
West 5, North 14, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
Hokkaido University Certified Review Board
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7934
recjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT1012200002
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Hokkaido University Hospital (Hokkaido), Yokohama City University Medical Centre (Kanagawa), Mie University (Mie), Kagawa University (Kagawa), Shizuoka Cancer Centre (Shizuoka), Sapporo City Hospital (Hokkaido), Gifu University (Gifu), Sapporo Medical University (Hokkaido), Kagoshima University (Kagoshima), Wakayama Medical University (Wakayama), Asahikawa Medical University (Hokkaido), IMS Sapporo Digestive Disease Centre General Hospital (Hokkaido), and Teine-Keijinkai Hospital (Hokkaido)
This study was approved by the Institutional Review Board of Hokkaido University Hospital and the director of each above participating institution.
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data management and monitoring:
All sampled data will be linked and anonymised and stored in a password-protected server (NorthNet), which is accessible only by the permitted physicians according to internal information governance rules. The data will be analysed after completion of the study and no interim analysis is planned. Monitoring will be performed by an independent monitor for every participating institution, and the results including unintended effects of the trial interventions or trial conduct will be reported to the research representative and the director of Hokkaido University Hospital. Severe adverse events will be immediately reported to the research representative and the director of Hokkaido University Hospital.
Patient and public involvement:
All authors involved in treatment/assessment have years of clinical experience in treating pancreatic cancer, including biliary drainage, chemotherapy/chemoradiotherapy, and related adverse events. The leading pancreaticobiliary physicians and endoscopists contributed to the development of the research questions based on their current knowledge of treatments and interventions for pancreatic cancer.
Patients will be questioned and assessed about their body conditions including appetite, body weight, and body temperature and complaints throughout each observational period of the study. This will allow us to develop an appropriate preoperative biliary drainage method using a SEMS. This study will include 100 patients who are scheduled to undergo preoperative chemotherapy/chemoradiotherapy with pancreatectomy for primary pancreatic cancer. The aforementioned items and intervention burden will be assessed by the participating pancreaticobiliary physicians and endoscopists, but not by the patients themselves. The study results will be disseminated to the study participants through patient symposia and associations without lucrative purposes or organisations for patients with pancreatic cancer.
Management information
Registered date
| 2020 | Year | 09 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045492
