UMIN-CTR Clinical Trial

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
Email	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
Email	hidkitam@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049287