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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013303
Receipt No. R000015512
Scientific Title Multicenter Investigative Study of Trans-Duodenal Drainage for Malignant Lower Biliary Obstruction by Means of Endoscopic Ultrasound using a New Fully-Covered Metallic Stent (AXIOS Stent) -OPTIONAL THERAPIES WITH USE OF AXIOS STENT FOR BILIARY DECOMPRESSION (ALTAIR study)-
Date of disclosure of the study information 2014/02/28
Last modified on 2018/09/01

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Basic information
Public title Multicenter Investigative Study of Trans-Duodenal Drainage for Malignant Lower Biliary Obstruction by Means of Endoscopic Ultrasound using a New Fully-Covered Metallic Stent (AXIOS Stent)
-OPTIONAL THERAPIES WITH USE OF AXIOS STENT FOR BILIARY DECOMPRESSION
(ALTAIR study)-
Acronym ALTAIR study
Scientific Title Multicenter Investigative Study of Trans-Duodenal Drainage for Malignant Lower Biliary Obstruction by Means of Endoscopic Ultrasound using a New Fully-Covered Metallic Stent (AXIOS Stent)
-OPTIONAL THERAPIES WITH USE OF AXIOS STENT FOR BILIARY DECOMPRESSION
(ALTAIR study)-
Scientific Title:Acronym ALTAIR study
Region
Japan Asia(except Japan)

Condition
Condition Malignant lower biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To carry out a multicenter study of the safety and efficacy of trans-duodenal EUS-guided drainage using a new fully-coated metallic stent (the AXIOS stent) in patients with malignant lower biliary obstruction.
Basic objectives2 Others
Basic objectives -Others Quality of Life (QOL): Assessed after one, four, and twelve weeks.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Safety: Incidence and severity of procedural accidents associated with the indwelling of the stent. Severity of procedural accidents will follow the diagnostic criteria of Cotton et al.
2) Success Rate of the Procedure: Confirmation of puncture, bile duct imaging, stent indwelling, and flow of bile (by cholangioscope, when possible)
3) Treatment Response Rate: Decrease in bilirubin of 50% or greater within two weeks, and 3 mg/dL or greater within four weeks.
Key secondary outcomes Quality of Life (QOL): Assessed after one, four, and twelve weeks according to the EORTC-QLQ-30 instrument.

Base
Study type

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
Device,equipment Maneuver
Interventions/Control_1 Endoscopic ultrasound-guided bile duct drainage using a new fully-covered metallic stent (AXIOS 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. 20 years of age or older.
2. Subjects suitable for EUS-guided drainage.
3. Subjects with obstructive jaundice (total serum bilirubin > 3.0 mg/dL) and subjects with bile duct inflammation due to malignant lower biliary duct obstruction for which histological evidence has been obtained.
4. Subjects in whom dilation of the bile duct has been observed using abdominal ultrasound,CT, or MRCP.
5. Subjects meeting the standards in whom ERCP was unsuccessful: 10 times pancreatic duct cannulation or 10 min procedure.
a. Subjects in whom the papilla cannot be observed or cannot be reached by the scope. Subjects in whom selective bile duct cannulation is impossible (subjects who have a tumorous duodenum, invasion of the papilla, or juxtapapillary duodenal diverticulum, or who present anatomical difficulties.)
b. Subjects in whom bile duct intubation has been attempted at least five times or for at least ten minutes.
c. Subjects in whom transpapillary passage of the stent to the site of stenosis is impossible and who are in the following high risk groups for pancreatitis following ERCP:
a. Subjects with past histories of pancreatitis following ERCP
b. Subjects with hereditary pancreatitis.
6. Subjects who have themselves voluntarily given written consent to participate in the study after receiving and fully understanding a full explanation.
Key exclusion criteria 1. Subjects who are pregnant or nursing
2. Abnormal coagulatory function (INR of 1.5 or greater that cannot be corrected by administering blood plasma, or a platelet count of less than 50.000/mm3.)
3. Subjects with biliary obstruction of the hepatic portal region.
4. Subjects who are scheduled to undergo pancreaticoduodenectomy.
5. Subjects with past histories of surgical treatment of the bile duct Roux-en-Y syndrome following gastric resection
6. Subjects who are in poor mental condition or who have mental disorders. Subjects who may not be able to understand the details of this study.
7. Subjects with poor presurgical or postsurgical assessments.
8. Subjects thought to have a prognosis of less than one month
9. Subjects with acute bleeding of the digestive tract
10. Subjects with end-stage hepatic disorders associated with portal hypertension, varicose veins, or ascites.
11. Subjects with 30% or greater liver metastasis
12. Subjects who present a difficult endoscopic approach.
13. Subjects with performance status 4.
14. Subjects with serious complications in other organs
15. Subjects from whom informed consent cannot be obtained
16. Subjects who are otherwise judged by the investigator or subinvestigator to be ineligible to participate in the study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Itoi
Organization Tokyo Medical University Hospital
Division name 4th Department of Internal Medicine
Zip code
Address 6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo 160-0023
TEL 03-3342-6111
Email itoi@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Itoi
Organization Tokyo Medical University Hospital
Division name 4th Department of Internal Medicine
Zip code
Address 6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo 160-0023
TEL 03-3342-6111
Homepage URL
Email itoi@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Hospital, 4th Department of Internal Medicine
Institute
Department

Funding Source
Organization Tokyo Medical University. (The metallic stents will be provided free of charge by Xlumena.)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Aichi Prefectural Cancer Center Department of Gastroenterology
Kinki University Department of Medicine Department of Gastroenterology
Tokyo University Department of Gastroenterology
Teine Keijinkai Hospital Center for Gastroenterology
Chinese University of Hong Kong&#8232; Prince of Wales Hospital
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 東京医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2015 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
2014 Year 02 Month 28 Day
Last modified on
2018 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015512

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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