UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study
Acronym	Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study
Scientific Title	Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study
Scientific Title:Acronym	Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study
Region	Japan

Condition
Condition	Resectable malignant hilar biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficancy and safety of plastic stent placement above the sphincter of Oddi for patients of resectable malignant hilar biliary obstruction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Time to recurrent biliary obstruction of inside-sten
Key secondary outcomes	1. Overall number of re-intervention after initial biliary drainage 2. Success rate and complication rate of inside-stent placement 3. Recurrent biliary obstruction rate of inside-stent 4. Overall morbidity and infectious complication rate after surgery

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	In undrainage patients, the site of biliary structure was confirmed endoscopically and naso-biliary drainage (ENBD) was performed firstly. After relieve of jaundice, ENBD was exchanged for inside-stent. In patients who had undergone endoscopic biliary drainage in previous hospital, endoscopic examination is performed and the existing stent was exchanged for inside-stent.
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. Resectable biliary tract cancer (intrahepatic, perihilar, or distal cholangiocarcinoma, gallbladder carcinoma) with obstructive jaundice 2. Life expectancy > 3 months 3. Endoscopic preoperative biliary drainage or radical surgery can be performed safely. 4. Endoscopic cholangiography shows the distance from the stricture to the sphincter of Oddi is at least 3cm. 5. Patients of age >= 20 years 6. ECOG performance status of 0-2 7. ASA calassification of 0-2 8. Adequate organ function 9. Written informed consent is required from all patients.
Key exclusion criteria	1. History of radiotherapy, chemotherapy or immunotherapy for malignant disease before starting the study treatment 2. Preoperative biliary drainage is not needed. 3. PTBD has been performed at previous hospital. 4. Severe complications such as intestinal pneumonia, pulmonary fibrosis, and heart failure 5. Psychosis or severe mental disorder 6. Pregnant or lactating female and patients who is considering pregnancy 7. Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akio Saiura
Organization	Japanese foundation for cancer research, Cancer institute hospital
Division name	Department of Gastroenterological Surgery
Zip code
Address	3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL	+81-3-3520-0111
Email	akio.saiura@jfcr.or.jp

Public contact
Name of contact person	1st name Middle name Last name Yu Takahashi
Organization	Japanese foundation for cancer research, Cancer institute hospital
Division name	Department of Gastroenterological Surgery
Zip code
Address	3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL	+81-3-3520-0111
Homepage URL
Email	yu.takahashi@jfcr.or.jp

Sponsor
Institute	Japanese foundation for cancer research, Cancer institute hospital
Institute
Department

Funding Source
Organization	Japanese foundation for cancer research, Cancer institute hospital
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 01 Month 30 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	Completed
Date of protocol fixation	2016 Year 12 Month 16 Day
Date of IRB	2016 Year 12 Month 08 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2019 Year 03 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	2016 Year 12 Month 28 Day
Last modified on	2021 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029295