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Trial registered on ANZCTR


Registration number
ACTRN12617001397303p
Ethics application status
Submitted, not yet approved
Date submitted
28/09/2017
Date registered
3/10/2017
Date last updated
3/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Endoscopic Ultrasound Guided Drainage of Bile in Patients with Benign Strictures of the Bile Duct
Scientific title
Safety and Efficacy of Endoscopic Ultrasound Guided Biliary Drainage in Patients with Benign Biliary Strictures
Secondary ID [1] 292948 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EUS-BD in BBS
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Benign Biliary Strictures 304843 0
Condition category
Condition code
Oral and Gastrointestinal 304145 304145 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional endoscopists who have performed numerous and various interventional endoscopic ultrasound procedures both locally and internationally, have trained overseas and attended courses on interventional endoscopic ultrasound will perform endoscopic ultrasound guided biliary drainage of benign biliary strictures by creating a fistula between the bile duct and stomach or duodenum using removable self expanding metal stents, face to face on patients with benign biliary strictures in a tertiary hospital. The average duration of the procedure is 40 minutes. Only one stent will be used for the study but if the stent to be placed becomes obstructed, then another stent will be placed. Blood samples will be taken to assess liver function on Day 2, week 2, month 1 then monthly unto 12 months post procedure.
Intervention code [1] 299188 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303462 0
To determine the clinical success of endoscopic ultrasound guided biliary drainage defined by a reduction in serum bilirubin by 50% at 2 weeks
Timepoint [1] 303462 0
2 weeks
Secondary outcome [1] 338989 0
To determine the technical success of EUS guided stent placement as defined by the ability to insert a stent across a fistula between the biliary tree and the gastrointestinal tract
Timepoint [1] 338989 0
Day of procedure
Secondary outcome [2] 338990 0
To determine the incidence and severity of adverse events as defined by the American Society of Gastrointestinal Endoscopy
Timepoint [2] 338990 0
Day of procedure, day 2 post procedure, week 2 post procedure and monthly post procedure until 12 months post procedure
Secondary outcome [3] 338991 0
To determine the average cost of endoscopic ultrasound guided biliary drainage by noting the quantity and cost of accessories used during the procedure and length of hospital stay
Timepoint [3] 338991 0
Day of procedure until discharge of patient from hospital
Secondary outcome [4] 338992 0
To determine stent patency defined as time interval between stent placement and its occlusion
Timepoint [4] 338992 0
Day 2, Week 2, and monthly post procedure until 12 months post procedure
Secondary outcome [5] 338993 0
To determine the rate of biliary re-intervention which is defined as any intervention done to improve biliary drainage
Timepoint [5] 338993 0
Day 2, week 2 and monthly post procedure until 12 months follow up
Secondary outcome [6] 339223 0
Quality of Life using the SF-36 score
Timepoint [6] 339223 0
one month then every month post procedure until 12 months

Eligibility
Key inclusion criteria
Patients with obstructive jaundice secondary to benign biliary strictures for biliary drainage who have failed ERCP to access the bile duct because of failed cannulation and surgically altered anatomy requiring double balloon enteroscopy guided ERCP and who refuse percutaneous trans biliary drainage
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are pregnant, who have bleeding tendency defined as having a platelet less than 50,000 or INR >1.5, PTT >50 seconds and malignant biliary strictures

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a pilot study of 20 patients only

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2017
Actual
Date of last participant enrolment
Anticipated
22/10/2018
Actual
Date of last data collection
Anticipated
21/10/2019
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9087 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 17582 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 297575 0
Hospital
Name [1] 297575 0
Royal Prince Alfred Hospital
Country [1] 297575 0
Australia
Primary sponsor type
Individual
Name
Payal Saxena
Address
Royal Prince Alfred Hospital Medical Center, Suite G10, 100 Carillon Avenue, Newtown, NSW 2042
Country
Australia
Secondary sponsor category [1] 296589 0
Individual
Name [1] 296589 0
Arthur John Kaffes
Address [1] 296589 0
Royal Prince Alfred Hospital Medical Center, Suite G10, 100 Carillon Avenue, Newtown, NSW 2042
Country [1] 296589 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298668 0
Royal Prince Alfred Hospital Research Ethics and Governance Office
Ethics committee address [1] 298668 0
Royal Prince Alfred Hospital 50 Missenden Road, CAMPERDOWN NSW 2050
Ethics committee country [1] 298668 0
Australia
Date submitted for ethics approval [1] 298668 0
09/08/2017
Approval date [1] 298668 0
Ethics approval number [1] 298668 0

Summary
Brief summary
Endoscopic retrograde cholangiopancreatography has been the standard of care for the management of bile blockage. This procedure combines the use of x-rays and an endoscope (a long, flexible, lighted tube). During the procedure, the doctor can see the inside of the stomach and small intestine, and inject dye into the drainage tubes (ducts) of the pancreas or bile to see them more clearly on x-ray. However, this procedure is not always possible or successful due to altered anatomy related to surgery or disease related causes. Percutaneous transhepatic biliary drainage has been used as an alternative in these cases. During this procedure a tube to drain the bile ducts is introduced through the skin and liver. However, this procedure is associated with a number of complications such as bile leak, peritonitis, tube dislodgement, recurrent infection and bleeding.

Endoscopic ultrasound is another procedure that uses sound waves to create visual images of the digestive tract, including the liver, bile ducts and pancreas. This procedure provides real time images and access to organs which are inaccessible by other means. Endoscopic ultrasound guided bile drainage is not a new procedure: several studies have looked at the safety and efficacy of this procedure in the management of bile blockage, however more studies are needed.

This study aims to determine the efficacy and safety of bile drainage via endoscopic ultrasound for benign blockage when endoscopic X-ray procedure was unsuccessful. Data collected in the study will help to understand if endoscopic ultrasound is an equivalent or is better for bile drainage than a procedure performed introducing a tube via the skin into the bile duct.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2078 2078 0 0
/AnzctrAttachments/373694-EUS BD in BBS Protocol v1 28June2017 submitted to ethics.docx (Protocol)

Contacts
Principal investigator
Name 77834 0
Dr Payal Saxena
Address 77834 0
Royal Prince Alfred Hospital Medical Center, Suite G10, 100 Carillon Avenue, Newtown, New South Wales, 2042
Country 77834 0
Australia
Phone 77834 0
+61295162033
Fax 77834 0
Email 77834 0
[email protected]
Contact person for public queries
Name 77835 0
Payal Saxena
Address 77835 0
Royal Prince Alfred Hospital Medical Center, Suite G10, 100 Carillon Avenue, Newtown, New South Wales, 2042
Country 77835 0
Australia
Phone 77835 0
+61295162033
Fax 77835 0
Email 77835 0
[email protected]
Contact person for scientific queries
Name 77836 0
Payal Saxena
Address 77836 0
Royal Prince Alfred Hospital Medical Center, Suite G10, 100 Carillon Avenue, Newtown, New South Wales, 2042
Country 77836 0
Australia
Phone 77836 0
+61295162033
Fax 77836 0
Email 77836 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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