UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043183 |
|---|---|
| Receipt number | R000049287 |
| Scientific Title | Confirmatory study of Simultaneous Double Stenting Using Endoscopic Ultrasound-hepaticogastrostomy in Combined Gastric Outlet and Biliary Obstructions |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/07/31 15:38:35 |
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Basic information
Public title
A Study on Optimal Biliary Drainage and Improvement of Gastrointestinal Dyspepsia in Patients with Simultaneous Biliary and Duodenal Stricture
Acronym
A Study on Optimal Biliary Drainage and Improvement of Gastrointestinal Dyspepsia in Patients with Simultaneous Biliary and Duodenal Stricture
Scientific Title
Confirmatory study of Simultaneous Double Stenting Using Endoscopic Ultrasound-hepaticogastrostomy in Combined Gastric Outlet and Biliary Obstructions
Scientific Title:Acronym
SPIRITS Study
Region
| Japan |
Condition
Condition
Gastric outlet obstruction and biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical efficacy and safety of simultaneous EUS-HGS and endoscopic duodenal stenting for duodenal biliary stricture
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical success rate
Key secondary outcomes
1) Percentage of successful clinical reduction 2) Percentage of improvement in GOO scoring system 3) Percentage of adverse events 4) Percentage of procedural success
5) Stent patency period 6) Stent survival patency period 7) Re-intervention success rate
8) Incidence of adverse events related to Re-intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic duodenal stenting + EUS-HGS
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) Patients with biliary stricture(MBO)and duodenal stricture(GOO)due to unresectable malignancy.
2) Diagnosis of pancreatic cancer or cholangiocarcinoma by diagnostic imaging or cytological/histological diagnosis.
3) Patients must meet one of the following criteria, or in blood tests.
4) T-Bil >1.5mg/dL, 2) AST >100U/L, 3) ALT >100U/L
5) Duodenal stent is not implanted.
6) GOOSS is 0 or 1 point.
7) The location of the duodenal stricture is type.1 or type.2.
8) MBO precedes and the need for treatment of GOO arises later, and the biliary tract is reoccluded at the time of the appearance of GOO, and the need for treatment of MBO and GOO arises simultaneously.
9) When MBO and the need for treatment of GOO occur simultaneously.
10) The patient does not have Bismuth II or higher hilar bile duct stenosis.
11) There is no gastrointestinal obstruction in the small or large intestine anterior to the duodenum.
12) The patient is expected to improve with biliary drainage.
13) The patient does not have ascites of more than moderate degree.
14) P.S. (ECOG): 0, 1, 2
15) Age: 20 years or older
16) Written consent for participation in the study has been obtained from the patient.
Key exclusion criteria
1) The physician judges that enrollment in this study is inappropriate.
2) The patient has moderate or severe acute cholangitis (diagnostic criteria and severity are in accordance with Tokyo Guidelines 2018).
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
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
shijioka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Kitamura |
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
hidkitam@ncc.go.jp
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
Japanese Governmental office
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
chuo-rinrishinsa-sg@ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | 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
| 2021 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 29 | Day |
Last modified on
| 2021 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049287
