UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048708 |
|---|---|
| Receipt number | R000055375 |
| Scientific Title | A multicenter, randomized controlled tiral of endoscopic ultrasonography-guided hepaticogastrostomy vs. endoscopic retrograde cholangiogram-guided self-expandable metal stent placement for distal malignant biliary obstruction in pancreatic cancer complicated with duodenal invasion |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/08/05 16:52:27 |
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Basic information
Public title
A randomized controlled tiral of endoscopic ultrasonography-guided hepaticogastrostomy vs. endoscopic retrograde cholangiogram-guided self-expandable metal stent placement for distal malignant biliary obstruction in pancreatic cancer complicated with duodenal invasion
Acronym
EUS-HGS vs ERC-BS for distal MBO in pancreatic cancer with duodenal invasion
Scientific Title
A multicenter, randomized controlled tiral of endoscopic ultrasonography-guided hepaticogastrostomy vs. endoscopic retrograde cholangiogram-guided self-expandable metal stent placement for distal malignant biliary obstruction in pancreatic cancer complicated with duodenal invasion
Scientific Title:Acronym
EUS-HGS vs ERC-BS for distal MBO in pancreatic cancer with duodenal invasion
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the safety and efficacy of EUS-HGS and ERC-BS in patients with advanced pancreatic cancer complicated with biliary obstruction and deudonal invasion, and to verify superiority of EUS-HGS in early recurrent biliary obstruction after SEMS placement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Early recurrent biliary obstruction rate
Key secondary outcomes
1) Technical success rate
2) Clinical success rate
3) Recurrent biliary obstruction rate
4) Time to recurrent biliary obstruction
5) Adverse event
6) Overall survival after SEMS placement
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
| Maneuver |
Interventions/Control_1
Endoscopic ultrasonography-guided hepaticogastrostomy (EUS-HGS)
Interventions/Control_2
Endoscopic retrograde cholangiography guided biliary SEMS placement (ERC-BS)
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) Pathological or radiologically diagnosed unresectable pancreatic cancer
2) Distal malignant biliary obstruction
3) Endoscopically diagnosed duodenal invasion (Radiological diagnosis for duodenal invasion is allowed in cases indwelled gastroduodenal stent. Pathological diagnosis are not always required regardless of the status of duodenal stent)
4) First SEMS placement for distal malignant biliary obstruction or first reintervention for the transpapillary-placed SEMS dysfucntion
5) Adequate oral intake
6) Age >= 18 years
7) Expecting survival time over 3 months
8) Patients who provided a written consent
Key exclusion criteria
1) Hilar biliary obstuction
2) Indwelled PTBD
3) Prior history of left hepatic lobectomy
4) Massive ascites requiring palliative paracentesis
5) Surgically altered anatomy other than Billroth 1 reconstruction
6) Indwelled or planning to gastroduodenal stent placement covering duodenal papilla
7) Impossible endoscopic access to the duodenal papilla due to duodenal obstruction
8) Performance status of 3-4
9) Bleeding tendency (platelet count <= 50,000/mm3, prothrombin time <= 70%)
10) Impossible to discontinue or replace antithrombotic/anticoagulant agents
11) Heart failure (NYHA of III-IV) or respiratory failure (PaO2 <= 60Torr)
12) pregnant or may be pregnant female
13) Patients who are judged to be inappropriate by the investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Nakai |
Organization
The University of Tokyo Hospital
Division name
Department of Endoscopy and Endoscopic Surgery
Zip code
113-8655
Address
7-3-1, Hongo Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
ynakai-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Naminatsu |
| Middle name | |
| Last name | Takahara |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1, Hongo Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
naminatsu-takahara@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, the University of Tokyo Hospital, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo 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
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院(東京都)、順天堂大学医学部附属順天堂医院(東京都)、埼玉医科大学総合医療センター(埼玉県)、がん研有明病院(東京都)、日本大学医学部附属板橋病院(東京都)、国立がん研究センター中央病院(東京都)、岐阜大学医学部附属病院(岐阜県)、岐阜市民病院(岐阜県)、岐阜県総合医療センター(岐阜県)、静岡県立静岡がんセンター(静岡県)、帝京大学医学部附属溝口病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | 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
| 2022 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | 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 | 08 | Month | 20 | Day |
Last modified on
| 2022 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055375
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| Registered date | File name |
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