The value of plugging percutaneous biliary drain tracts following drain removal

ISRCTN	ISRCTN02258149
DOI	https://doi.org/10.1186/ISRCTN02258149
Secondary identifying numbers	N0050153127

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 21/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Clive Kay
Scientific

Radiology Department
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 (0)1274 364321
Email	kaycl44@hotmail.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The value of plugging percutaneous biliary drain tracts following drain removal
Study objectives	1. Does the use of medical collagen ('LYOSTYPT') stop bile leak following removal of percutaneous biliary drains? 2. Does the prevention of bile leak lead to a decrease in complications such as pain, fever and raised inflammatory markers?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Obstructive jaundice
Intervention	Patients with obstructive jaundice not amenable to endoscopic treatment (primary investigation and treatment modality) referred for: PTC (percutaneous transhepatic cholangiography) +/ - External percutaneous drain +/ - Internal drainage (stent) as a one stage procedure. Wait for bilirubin to fall, temperature to settle and biliary tree to decompress. Patients re-attend the radiology department for drain removal. Randomisation to drain tract plugged with collagen or drain not plugged. Follow-up on ward by research nurses days 1, 2, 3 and 5 (both groups).
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Medical collagen
Primary outcome measure	1. Pain score after drain removal 2. Complication rate
Secondary outcome measures	Not provided at time of registration
Overall study start date	11/10/2004
Completion date	01/07/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	30 patients: 15 patients will be recruited for the tract plugging process and 15 for the non tract plugging
Key inclusion criteria	Patients already identified as requiring radiological intervention for life-threatening biliary obstruction
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	11/10/2004
Date of final enrolment	01/07/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bradford Royal Infirmary

Bradford
BD9 6RJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Bradford Teaching Hospitals NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

21/03/2017: No publications found, verifying study status with principal investigator.