Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
01/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Clive Kay

ORCID ID

Contact details

Radiology Department
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 364321
kaycl44@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0050153127

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Medical collagen

Primary outcome measures

1. Pain score after drain removal
2. Complication rate

Secondary outcome measures

Not provided at time of registration

Overall trial start date

11/10/2004

Overall trial end date

01/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients already identified as requiring radiological intervention for life-threatening biliary obstruction.
Once external biliary drainage is established patients will be approached to ask if they want to take part in the trial.
If they agree to participate in the study they will be randomised to tract plugging or no tract plugging.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients: 15 patients will be recruited for the tract plugging process and 15 for the non tract plugging

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

11/10/2004

Recruitment end date

01/07/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Radiology Department
Bradford
BD9 6RJ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Bradford Teaching Hospitals NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes