<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477005</url>
  </required_header>
  <id_info>
    <org_study_id>20GA041</org_study_id>
    <nct_id>NCT04477005</nct_id>
  </id_info>
  <brief_title>Archimedes Bio-degradable Bile Duct Stent Study</brief_title>
  <acronym>ABBS</acronym>
  <official_title>Prospective Observational Cohort Study: To Assess the Utility of Bio-degradable Bile Duct Stent in the Drainage of Bile Duct.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nottingham University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective observational cohort study to assess the utility of bio-degradable bile&#xD;
      duct stent in the drainage of bile duct. All consecutive patients who will undergo ERCP&#xD;
      procedure for bile leaks and patients with bile duct stones and intact gall bladder will be&#xD;
      recruited to the study. The planned sample size is 53 and patients will be followed up for&#xD;
      180 days. The primary objective is to assess the utility of biodegradable bile duct plastic&#xD;
      stents in the drainage of bile duct.&#xD;
&#xD;
      The secondary Secondary objectives are To assess&#xD;
&#xD;
        1. Technical success of biodegradable stents&#xD;
&#xD;
        2. Complications&#xD;
&#xD;
        3. Patient related cost savings (Time off work, travel time for the patient)&#xD;
&#xD;
        4. Hospital related cost savings (Repeat procedure costs, follow up appointments)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Multi-centre prospective observational cohort study assessing biodegradable stents&#xD;
      in the drainage of bile duct. The participating organisations are Nottingham university&#xD;
      hospitals NHS trust which is the host and sponsor of this study, University college London&#xD;
      Hospitals NHS foundation trust and Leeds teaching hospitals NHS trust.&#xD;
&#xD;
      The population studied will be patients who need temporary bile duct stent insertion for bile&#xD;
      leak and patients who had ERCP for removal of CBD stones and have stones either in the neck&#xD;
      of gall bladder or cystic duct and awaiting cholecystectomy. These are the group of patients&#xD;
      who may not benefit from a repeat endoscopic procedure to remove the stent. As the target&#xD;
      population is rare, all consecutive patients with above condition will be recruited to the&#xD;
      study.&#xD;
&#xD;
      All patients who are referred for ERCP will be screened to see if they meet the eligibility&#xD;
      criteria to participate in the study. The patient information sheet (PIS) will be sent to the&#xD;
      patient along with the endoscopy appointment. The pateints will be consented both for the&#xD;
      procedure and the study on the day of the procedure. Then the patients will have the&#xD;
      procedure in their respective endoscopic units. All ERCP procedures will be done either by an&#xD;
      accredited endoscopist or by a trainee under the close supervision of the accredited&#xD;
      endoscopist.&#xD;
&#xD;
      Once the patients have their treatment, the patients will be observed for four hours for&#xD;
      complications. Then discharged home if they are well and do not have any symptoms such as&#xD;
      pain, persistent low blood pressure (defined as systolic less than 100) and have recovered&#xD;
      from the effects of sedation. If at all the pateints develop any of the above symptoms, then&#xD;
      the patients will be admitted for an overnight observation. The patients will have a&#xD;
      telephone consultation by research specialist nurses the next day to assess if they have&#xD;
      symptoms such as abdominal pain, vomiting, vomiting of blood and dark tarry stools. If the&#xD;
      patients develop any of these symptoms, the patients will be assessed in the bio-medical&#xD;
      research centre or respective inpatient facility in relevant centres. The patients will then&#xD;
      have a blood test including full blood count, liver function and renal function. Amylase will&#xD;
      be done only if they complain of abdominal pain as a proportion of patients will have&#xD;
      hyper-amylasaemia following ERCP. The patients will also receive a telephone consultation&#xD;
      (Research nurse) on day 7 post procedure to assess if they have any of the above symptoms. A&#xD;
      quality of life questionnaire will be completed at this stage.&#xD;
&#xD;
      The investigators will be using slow degrading stents so, therefore the patients will have an&#xD;
      abdominal x-ray 90 days after the procedure and if the stent is not visible on abdominal&#xD;
      X-ray then they would have completed the study. As recent studies have shown that the stent&#xD;
      appear partially degraded in some patients, if the stent is visible on x-ray then the&#xD;
      patients will have one more follow up visit with an abdominal x-ray at 180 days. The&#xD;
      invetstigator will not remove the stent as the stent would have partially degraded and would&#xD;
      have lost its tensile strength.&#xD;
&#xD;
      Almost all bile leaks are inpatients so the resolution of bile leak will be assessed while&#xD;
      they are inpatients. The resolution of bile leak is defined as no output from the external&#xD;
      drain that was inserted through the skin under radiological guidance. For bile duct stones it&#xD;
      is the prevention of bile duct infection (Cholangitis). The pateints will have telephone&#xD;
      consultations on days 1,30,60,90 and 180 to asses if they have symptoms such as abdominal&#xD;
      pain, jaundice. A quality of life questionnaire (EQ-5D-5L) will be completed at all these&#xD;
      visits. Once the patient completes all of the above, they will have completed the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2020</start_date>
  <completion_date type="Actual">August 2, 2023</completion_date>
  <primary_completion_date type="Actual">September 23, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Resolution of bile leak</measure>
    <time_frame>180 days</time_frame>
    <description>In patients who have bile leak post HPB surgery, They will have an external drain to drain the leaked bile. Resolution of bile leak is defined as no output of bile through the external drain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of cholangitis in patients who had ERCP for bile duct stones and are awaiting gall bladder removal.</measure>
    <time_frame>180 days</time_frame>
    <description>Cholangitis- infection of bile duct ( fever, rigors, elevated white cell count and CRP). Incidence of cholangitis post procedure will be reported.</description>
  </primary_outcome>
  <enrollment type="Actual">64</enrollment>
  <condition>Bile Leak</condition>
  <condition>Common Bile Duct Stone With Chronic Cholecystitis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ERCP and insertion ofBio-degradable bile duct stent</intervention_name>
    <description>ERCP is an accepted mode of treatment and patients rarely need surgery for bile leaks and bile duct stents. Endoscopic management involves sphincterotomy (cutting open the Sphincter of Oddi) and insertion of a plastic or metal stent. Instead of placing a plastic stent bio-degradable stent will be placed. They will be followed up on Day 1, 7,30, 60,90 and 180 days. they will have abdominal x-ray on day 90 and day180.</description>
    <other_name>Archimedes BD stent</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients who need ERCP for bile leak or bile duct stones except participants who&#xD;
        are pregnant or breast feeding.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
               -  Male or Female, aged 18 years or above.&#xD;
&#xD;
               -  Patients who have an indication for ERCP.&#xD;
&#xD;
               -  Patients who have bile leak either post cholecystectomy or liver resection.&#xD;
&#xD;
               -  Patients who are on the waiting list for cholecystectomy for gall stones but have&#xD;
                  bile duct stones and listed for removal of bile duct stones.&#xD;
&#xD;
               -  Able (in the Investigators opinion) and willing to comply with all study&#xD;
                  requirements.&#xD;
&#xD;
               -  Willing to allow his or her General Practitioner and consultant, if appropriate,&#xD;
                  to be notified of participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female participants who is pregnant, lactating or planning pregnancy during the course&#xD;
             of the study.&#xD;
&#xD;
          -  Patients who are unable to consent for the study.&#xD;
&#xD;
          -  Participant who is terminally ill&#xD;
&#xD;
          -  Patients who come for ERCP and routine stent change&#xD;
&#xD;
          -  Any other significant disease or disorder which, in the opinion of the Investigator,&#xD;
             may either put the participants at risk because of participation in the study, or may&#xD;
             influence the result of the study, or the participant's ability to participate in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suresh Vasan Venkatachalapathy, MRCP(Gastr)</last_name>
    <role>Principal Investigator</role>
    <affiliation>NIHR Nottingham BRC,Nottingham University Hospitals NHS Trust and the University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All personal identifiable information collected during the study will be coded, depersonalised with unique codes for each patient. The study will be compliant with the requirements of the General Data Protection Regulation 2018 and the Data Protection Act 2018.&#xD;
The CRF will only collect the minimum required information for the purposes of the trial. CRFs will be held securely, in a locked room in a locked cupboard.All patient data will be stored in an encrypted computer with password access at the NIHR Nottingham BRC, Nottingham University Hospitals NHS Trust and the University of Nottingham. Members other than the direct care team will not have access to this data.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477005
org study id: 20GA041
nct id: NCT04477005
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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)
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.
observational model: Cohort
time perspective: Prospective
measure: Resolution of bile leak
time frame: 180 days
description: In patients who have bile leak post HPB surgery, They will have an external drain to drain the leaked bile. Resolution of bile leak is defined as no output of bile through the external drain.
measure: Incidence of cholangitis in patients who had ERCP for bile duct stones and are awaiting gall bladder removal.
time frame: 180 days
description: Cholangitis- infection of bile duct ( fever, rigors, elevated white cell count and CRP). Incidence of cholangitis post procedure will be reported.
intervention type: Device
intervention name: ERCP and insertion ofBio-degradable bile duct stent
description: ERCP is an accepted mode of treatment and patients rarely need surgery for bile leaks and bile duct stents. Endoscopic management involves sphincterotomy (cutting open the Sphincter of Oddi) and insertion of a plastic or metal stent. Instead of placing a plastic stent bio-degradable stent will be placed. They will be followed up on Day 1, 7,30, 60,90 and 180 days. they will have abdominal x-ray on day 90 and day180.
other name: Archimedes BD stent
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suresh Vasan Venkatachalapathy, MRCP(Gastr)
role: Principal Investigator
affiliation: NIHR Nottingham BRC,Nottingham University Hospitals NHS Trust and the University of Nottingham
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cholecystitis
sharing ipd: No
ipd description: All personal identifiable information collected during the study will be coded, depersonalised with unique codes for each patient. The study will be compliant with the requirements of the General Data Protection Regulation 2018 and the Data Protection Act 2018.
The CRF will only collect the minimum required information for the purposes of the trial. CRFs will be held securely, in a locked room in a locked cupboard.All patient data will be stored in an encrypted computer with password access at the NIHR Nottingham BRC, Nottingham University Hospitals NHS Trust and the University of Nottingham. Members other than the direct care team will not have access to this data.