<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/NCT02195115</url>
  </required_header>
  <id_info>
    <org_study_id>ULJRR033173</org_study_id>
    <secondary_id>U54GM104942</secondary_id>
    <nct_id>NCT02195115</nct_id>
  </id_info>
  <brief_title>Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia</brief_title>
  <official_title>Randomized Controlled Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CAMC Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Research Resources (NCRR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>CAMC Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to challenge the existing clinical practice of employing&#xD;
      laparoscopic cholecystectomy as the treatment for gallbladder dyskinesia by comparing it to a&#xD;
      regimen of active non-surgical therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Willing and eligible patients will be enrolled into the trial and randomized to surgical vs&#xD;
      non-surgical treatment following informed consent. The following information will be&#xD;
      collected over the next 18 months: age,race, sex, baseline and follow-up quality of life&#xD;
      quationnaire scores, a complete medical history, including co-morbid illnesses, medications&#xD;
      and surgical history, and a complete assessment of symptoms, including disease specific&#xD;
      symptoms against the Rome III criteria for functional gallbladder disorder. Patients&#xD;
      randomized to surgery will be referred for immediate laparoscopic cholecystectomy. Patients&#xD;
      in the non-surgical management group will be counseled on maintenance of a low-fat diet, and&#xD;
      provided with a prescription for amitriptyline 25mg once daily.&#xD;
&#xD;
      Patients with persistent, non responsive symptoms that fail to respond to at least one week&#xD;
      of administration of amitriptyline will be allowed to voluntarily, cross over into the&#xD;
      surgically treated group.&#xD;
&#xD;
      After randomization, certain data collection points will be unique to the two groups. These&#xD;
      are as follows and are in addition to the general data which will be collected from both&#xD;
      groups:&#xD;
&#xD;
      Surgery group: operative/pathology findings &amp; operative complications&#xD;
&#xD;
      Non-surgical group:&#xD;
&#xD;
      Patients will be asked to maintain a food diary and a symptom diary. Patients will be asked&#xD;
      to report any medication related side effects.&#xD;
&#xD;
      Both groups will receive a phone call for assessment of conditions. Non-surgical groups will&#xD;
      be asked to report any medication related side effects.&#xD;
&#xD;
      Follow-up for both groups will continue throughout the 18 month period. In addition to the&#xD;
      monthly calls, Patients will be contacted every three months after their initial treatment to&#xD;
      take the SF-8 questionnaire and obtain an assessment of symptoms using the Rome III criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SF-8</measure>
    <time_frame>18 months</time_frame>
    <description>Administration of SF-8 (health questionnaire) survey prior to the initiation of treatment and periodically after the initiation of treatment to assess the ability of cholecystectomy to provide durable symptomatic relief.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rome III Criteria</measure>
    <time_frame>18 months</time_frame>
    <description>Comparison of the results of surgery to those of non-surgical treatment based on degree of relief of symptoms described in the Rome III criteria and follow-up SF-8 scores.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Gallbladder Dyskinesia</condition>
  <arm_group>
    <arm_group_label>Laparoscopic cholecystectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>surgical removal of gallbladder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-operative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of amitriptyline 25mg daily, Low Fat-Low Cholesterol Diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Cholecystectomy</intervention_name>
    <arm_group_label>Laparoscopic cholecystectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>amitriptyline</intervention_name>
    <arm_group_label>Non-operative treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>low-fat and low cholesterol diet</intervention_name>
    <arm_group_label>Non-operative treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with a normal gallbladder Patients with symptoms compatible with gallbladder&#xD;
        dyskinesia (functional gallbladder disorder) as defined by the Rome III criteria Patients&#xD;
        with a Cholecystokinin hepatobiliary (CCK-HIDA) scintigraphy gallbladder ejection fraction&#xD;
        of &lt;38%, performed at a facility using updated Society of Nuclear Medicaine guidelines for&#xD;
        test administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with other known sources of chronic abdominal pain (ex: Crohn's disease) Patients&#xD;
        with chronic narcotic use which will affect the reproducibility and validity of the&#xD;
        CCK-HIDA results Patient with a history of allergy to amitriptyline Patients with a seizure&#xD;
        disorder&#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>Bryan K Richmond, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University, Charleston Division ; Professor of Surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jerri Walker</last_name>
    <phone>304-388-9995</phone>
    <email>jerri.walker@CAMC.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kristi Sutphin</last_name>
    <phone>304-388-9945</phone>
    <email>kristi.sutphin@camc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Charleston Area Medical Center</name>
      <address>
        <city>Charleston,</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Bryan K Richmond, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>March 4, 2015</last_update_submitted>
  <last_update_submitted_qc>March 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 5, 2015</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>Biliary Dyskinesia</mesh_term>
    <mesh_term>Dyskinesias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amitriptyline</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02195115
org study id: ULJRR033173
secondary id: U54GM104942
nct id: NCT02195115
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The goal of this study is to challenge the existing clinical practice of employing
      laparoscopic cholecystectomy as the treatment for gallbladder dyskinesia by comparing it to a
      regimen of active non-surgical therapy.
Willing and eligible patients will be enrolled into the trial and randomized to surgical vs
      non-surgical treatment following informed consent. The following information will be
      collected over the next 18 months: age,race, sex, baseline and follow-up quality of life
      quationnaire scores, a complete medical history, including co-morbid illnesses, medications
      and surgical history, and a complete assessment of symptoms, including disease specific
      symptoms against the Rome III criteria for functional gallbladder disorder. Patients
      randomized to surgery will be referred for immediate laparoscopic cholecystectomy. Patients
      in the non-surgical management group will be counseled on maintenance of a low-fat diet, and
      provided with a prescription for amitriptyline 25mg once daily.

      Patients with persistent, non responsive symptoms that fail to respond to at least one week
      of administration of amitriptyline will be allowed to voluntarily, cross over into the
      surgically treated group.

      After randomization, certain data collection points will be unique to the two groups. These
      are as follows and are in addition to the general data which will be collected from both
      groups:

      Surgery group: operative/pathology findings & operative complications

      Non-surgical group:

      Patients will be asked to maintain a food diary and a symptom diary. Patients will be asked
      to report any medication related side effects.

      Both groups will receive a phone call for assessment of conditions. Non-surgical groups will
      be asked to report any medication related side effects.

      Follow-up for both groups will continue throughout the 18 month period. In addition to the
      monthly calls, Patients will be contacted every three months after their initial treatment to
      take the SF-8 questionnaire and obtain an assessment of symptoms using the Rome III criteria.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SF-8
time frame: 18 months
description: Administration of SF-8 (health questionnaire) survey prior to the initiation of treatment and periodically after the initiation of treatment to assess the ability of cholecystectomy to provide durable symptomatic relief.
measure: Rome III Criteria
time frame: 18 months
description: Comparison of the results of surgery to those of non-surgical treatment based on degree of relief of symptoms described in the Rome III criteria and follow-up SF-8 scores.
arm group label: Laparoscopic cholecystectomy
arm group type: Active Comparator
description: surgical removal of gallbladder
arm group label: Non-operative treatment
arm group type: Active Comparator
description: Administration of amitriptyline 25mg daily, Low Fat-Low Cholesterol Diet
intervention type: Procedure
intervention name: Laparoscopic Cholecystectomy
arm group label: Laparoscopic cholecystectomy
intervention type: Drug
intervention name: amitriptyline
arm group label: Non-operative treatment
intervention type: Other
intervention name: low-fat and low cholesterol diet
arm group label: Non-operative treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bryan K Richmond, MD
role: Principal Investigator
affiliation: West Virginia University, Charleston Division ; Professor of Surgery
last name: Jerri Walker
phone: 304-388-9995
email: jerri.walker@CAMC.org
last name: Kristi Sutphin
phone: 304-388-9945
email: kristi.sutphin@camc.org
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Biliary Dyskinesia
mesh term: Dyskinesias
mesh term: Amitriptyline