UMIN-CTR Clinical Trial

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

Malignant lower biliary obstruction

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Medical University Hospital, 4th Department of Internal Medicine

Institute

Department

Personal name

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

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
 Prince of Wales Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京医科大学病院（東京都）

Date of disclosure of the study information

2014

Year

02

Month

28

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2014

Year

02

Month

28

Day

Last modified on

2018

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015512