Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04477005 |
Other study ID # |
20GA041 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 11, 2020 |
Est. completion date |
August 2, 2023 |
Study information
Verified date |
August 2023 |
Source |
Nottingham University Hospitals NHS Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This is a prospective observational cohort study to assess the utility of bio-degradable bile
duct stent in the drainage of bile duct. All consecutive patients who will undergo ERCP
procedure for bile leaks and patients with bile duct stones and intact gall bladder will be
recruited to the study. The planned sample size is 53 and patients will be followed up for
180 days. The primary objective is to assess the utility of biodegradable bile duct plastic
stents in the drainage of bile duct.
The secondary Secondary objectives are To assess
1. Technical success of biodegradable stents
2. Complications
3. Patient related cost savings (Time off work, travel time for the patient)
4. Hospital related cost savings (Repeat procedure costs, follow up appointments)
Description:
This is a Multi-centre prospective observational cohort study assessing biodegradable stents
in the drainage of bile duct. The participating organisations are Nottingham university
hospitals NHS trust which is the host and sponsor of this study, University college London
Hospitals NHS foundation trust and Leeds teaching hospitals NHS trust.
The population studied will be patients who need temporary bile duct stent insertion for bile
leak and patients who had ERCP for removal of CBD stones and have stones either in the neck
of gall bladder or cystic duct and awaiting cholecystectomy. These are the group of patients
who may not benefit from a repeat endoscopic procedure to remove the stent. As the target
population is rare, all consecutive patients with above condition will be recruited to the
study.
All patients who are referred for ERCP will be screened to see if they meet the eligibility
criteria to participate in the study. The patient information sheet (PIS) will be sent to the
patient along with the endoscopy appointment. The pateints will be consented both for the
procedure and the study on the day of the procedure. Then the patients will have the
procedure in their respective endoscopic units. All ERCP procedures will be done either by an
accredited endoscopist or by a trainee under the close supervision of the accredited
endoscopist.
Once the patients have their treatment, the patients will be observed for four hours for
complications. Then discharged home if they are well and do not have any symptoms such as
pain, persistent low blood pressure (defined as systolic less than 100) and have recovered
from the effects of sedation. If at all the pateints develop any of the above symptoms, then
the patients will be admitted for an overnight observation. The patients will have a
telephone consultation by research specialist nurses the next day to assess if they have
symptoms such as abdominal pain, vomiting, vomiting of blood and dark tarry stools. If the
patients develop any of these symptoms, the patients will be assessed in the bio-medical
research centre or respective inpatient facility in relevant centres. The patients will then
have a blood test including full blood count, liver function and renal function. Amylase will
be done only if they complain of abdominal pain as a proportion of patients will have
hyper-amylasaemia following ERCP. The patients will also receive a telephone consultation
(Research nurse) on day 7 post procedure to assess if they have any of the above symptoms. A
quality of life questionnaire will be completed at this stage.
The investigators will be using slow degrading stents so, therefore the patients will have an
abdominal x-ray 90 days after the procedure and if the stent is not visible on abdominal
X-ray then they would have completed the study. As recent studies have shown that the stent
appear partially degraded in some patients, if the stent is visible on x-ray then the
patients will have one more follow up visit with an abdominal x-ray at 180 days. The
invetstigator will not remove the stent as the stent would have partially degraded and would
have lost its tensile strength.
Almost all bile leaks are inpatients so the resolution of bile leak will be assessed while
they are inpatients. The resolution of bile leak is defined as no output from the external
drain that was inserted through the skin under radiological guidance. For bile duct stones it
is the prevention of bile duct infection (Cholangitis). The pateints will have telephone
consultations on days 1,30,60,90 and 180 to asses if they have symptoms such as abdominal
pain, jaundice. A quality of life questionnaire (EQ-5D-5L) will be completed at all these
visits. Once the patient completes all of the above, they will have completed the study.