<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/NCT03770247</url>
  </required_header>
  <id_info>
    <org_study_id>MD ∕ 17.08.53</org_study_id>
    <nct_id>NCT03770247</nct_id>
  </id_info>
  <brief_title>Intraoperative Versus CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer</brief_title>
  <official_title>Direct Intraoperative Injection Versus Percutaneous CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer ; Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many studies had stated that the coeliac plexus neurolysis (CPN) is a safe and effective&#xD;
      treatment method of pain associated with pancreatic cancer. The neurolytic injectate is&#xD;
      usually alcohol 50-100%; however, phenol &gt;5% is also possible to use. Nowadays, there are&#xD;
      several techniques to access the coeliac plexus (per cutaneous using fluoroscopy or computed&#xD;
      tomographic imaging (CT), surgical and endoscopic ultrasound). However, the percutaneous&#xD;
      computed tomography guided technique is the gold standard technique, it has multiple&#xD;
      drawbacks as availability and cost of imaging modality, exposure to radiation and multiple&#xD;
      complications.Surgical technique in spite of being easy, cheap but there is a controversy&#xD;
      about its efficacy. Also there is no head to head comparison between the surgical technique&#xD;
      and the percutaneous technique.In this study we hypothesized that intraoperative technique&#xD;
      has the same efficacy of percutaneous celiac block technique with less complication and cost&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aimed to compare the efficacy of the surgical technique versus the per cutaneous&#xD;
      computed tomographic guided technique of celiac plexus neurolysis for pain management in&#xD;
      unresectable pancreatic cancer . all patients suffering from pain of pancreatic cancer with&#xD;
      VAS≥5 undergoing laparotomy and proved to be unresectable either undergoing biopsy or bypass&#xD;
      surgery will receive celiac plexus neurolysis either intraoperative or post operative CT&#xD;
      guided . All patients will be managed by systemic analgesic if the block not sufficient . In&#xD;
      this study we will give the patient the analgesic according to WHO recommendation as starting&#xD;
      by non steroidal anti inflammatory drugs as diclofenac sodium, if it is not sufficient we&#xD;
      will give them opioids as tramadol, and for neuropathic pain gabapentin. All drugs will be&#xD;
      given with escalating dose . Failed block defined as change in VAS between VAS BASELINE AND&#xD;
      ONE MONTH ≤ 3 may need to repeat the block by percutaneous technique .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>assesment of efficacy in pain palliation by change in VAS after one month</measure>
    <time_frame>one month</time_frame>
    <description>change in visual analogue scale ( VAS) after one month visual analogue scale is pain scale from 0 to 10 , 0 no pain , 10 maximum pain lower VAS better than higher .a positive responce defined as decrease of VAS of equal or more than 3</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of complication</measure>
    <time_frame>one month</time_frame>
    <description>report the occurrence of complication as headache , diarrhea , vomiting , back pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total analgesic consumption</measure>
    <time_frame>6 month</time_frame>
    <description>the amount of analgesic required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of pain palliation</measure>
    <time_frame>6 month</time_frame>
    <description>change of visual analogue scale from baseline for 6 months visual analogue scale represent pain from 0 no pain to 10 maximum pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>need of other injection</measure>
    <time_frame>6 months</time_frame>
    <description>if failure of intervention occured patient may need another intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Pain, Chronic</condition>
  <arm_group>
    <arm_group_label>intraoperative group (IOCPN group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraoperative celiac plexus neurolysis Before closure of the abdomen the surgeon will expose the aorta at the level of the celiac trunk.With the stomach retracted inferiorly, the index and second finger of the surgeon's left hand straddle the aorta with the index finger placed on the splenic artery and the second finger on the common hepatic artery. we will use of a 20- gauge spinal needle (in contrast to the usual short intravenous needle) allows better visualization and access to this area, especially in deep patients, while a 10 ml syringe permits the surgeon to control the injection with the right hand alone.(10) Twenty ml of 90 % alcohol, five ml lidocaine 2%, five mg dexamethasone will be injected in each side of the aorta after aspiration to exclude intravascular or subarachnoid injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CT group (CTCPN group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CT guided celiac plexus neurolysis After one week of the operation and the patient completely awake, the patient will be transferred to CT lab. The procedure will be done after attachment of basic monitors and transfusion of 500 ml saline in 20 G cannula before starting the procedure and the patient will be given 5 mg midazolam as a sedation. The procedure will be done by anesthetist and radiologist who had a good experience in celiac plexus neurolysis. In our study we will use the classic posterior bilateral approach. The patient will be in the prone position. After sterilization of the back by chlorohixidine 10 % , subcutaneous injection of 5 ml lidocaine as a local anaesthesia until a wheel will be formed then the procedure will be done. We will use 20 G Chiba needle under guidance of CT. Twenty ml of 95% alcohol , five ml lidocaine 2 % and five mg dexamethasone in each side of the aorta after aspiaration to exclude intravascular injection and subarachnoid injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intraoperative celiac plexus neurolysis</intervention_name>
    <description>neurolysis of celiac plexus by intraoperative techniques</description>
    <arm_group_label>intraoperative group (IOCPN group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CT guided celiac plexus neurolysis</intervention_name>
    <description>Neurolysis of celiac plexus percutaneously by CT guidance</description>
    <arm_group_label>CT group (CTCPN group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients suffering of pain from pancreatic cancer with baseline VAS≥5, scheduled&#xD;
             for surgical assessment&#xD;
&#xD;
          -  patients proven histololgically to be unresectable&#xD;
&#xD;
          -  patients undergoing either biopsy or bypass surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient with resectable tumour will be excluded.&#xD;
&#xD;
          -  Patient with coagulopathy.&#xD;
&#xD;
          -  patient with aortic aneurysm.&#xD;
&#xD;
          -  patient with any disease contraindicating any sympathetic blockade as advanced cardiac&#xD;
             disease .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tarek M. Shams, MD</last_name>
    <role>Study Director</role>
    <affiliation>: Professor of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mahmoud M. Elsedeiq, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>assistan lecturer of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed A. Ghanim, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Assistant Professor of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ibrahim I. Abd El-basir, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Lecturer of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura university , gastrointestinal surgery center</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 22, 2019</last_update_submitted>
  <last_update_submitted_qc>December 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2019</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>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03770247
org study id: MD ∕ 17.08.53
nct id: NCT03770247
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Many studies had stated that the coeliac plexus neurolysis (CPN) is a safe and effective
      treatment method of pain associated with pancreatic cancer. The neurolytic injectate is
      usually alcohol 50-100%; however, phenol >5% is also possible to use. Nowadays, there are
      several techniques to access the coeliac plexus (per cutaneous using fluoroscopy or computed
      tomographic imaging (CT), surgical and endoscopic ultrasound). However, the percutaneous
      computed tomography guided technique is the gold standard technique, it has multiple
      drawbacks as availability and cost of imaging modality, exposure to radiation and multiple
      complications.Surgical technique in spite of being easy, cheap but there is a controversy
      about its efficacy. Also there is no head to head comparison between the surgical technique
      and the percutaneous technique.In this study we hypothesized that intraoperative technique
      has the same efficacy of percutaneous celiac block technique with less complication and cost
This study aimed to compare the efficacy of the surgical technique versus the per cutaneous
      computed tomographic guided technique of celiac plexus neurolysis for pain management in
      unresectable pancreatic cancer . all patients suffering from pain of pancreatic cancer with
      VAS≥5 undergoing laparotomy and proved to be unresectable either undergoing biopsy or bypass
      surgery will receive celiac plexus neurolysis either intraoperative or post operative CT
      guided . All patients will be managed by systemic analgesic if the block not sufficient . In
      this study we will give the patient the analgesic according to WHO recommendation as starting
      by non steroidal anti inflammatory drugs as diclofenac sodium, if it is not sufficient we
      will give them opioids as tramadol, and for neuropathic pain gabapentin. All drugs will be
      given with escalating dose . Failed block defined as change in VAS between VAS BASELINE AND
      ONE MONTH ≤ 3 may need to repeat the block by percutaneous technique .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: assesment of efficacy in pain palliation by change in VAS after one month
time frame: one month
description: change in visual analogue scale ( VAS) after one month visual analogue scale is pain scale from 0 to 10 , 0 no pain , 10 maximum pain lower VAS better than higher .a positive responce defined as decrease of VAS of equal or more than 3
measure: incidence of complication
time frame: one month
description: report the occurrence of complication as headache , diarrhea , vomiting , back pain
measure: total analgesic consumption
time frame: 6 month
description: the amount of analgesic required
measure: duration of pain palliation
time frame: 6 month
description: change of visual analogue scale from baseline for 6 months visual analogue scale represent pain from 0 no pain to 10 maximum pain
measure: need of other injection
time frame: 6 months
description: if failure of intervention occured patient may need another intervention
arm group label: intraoperative group (IOCPN group)
arm group type: Experimental
description: Intraoperative celiac plexus neurolysis Before closure of the abdomen the surgeon will expose the aorta at the level of the celiac trunk.With the stomach retracted inferiorly, the index and second finger of the surgeon's left hand straddle the aorta with the index finger placed on the splenic artery and the second finger on the common hepatic artery. we will use of a 20- gauge spinal needle (in contrast to the usual short intravenous needle) allows better visualization and access to this area, especially in deep patients, while a 10 ml syringe permits the surgeon to control the injection with the right hand alone.(10) Twenty ml of 90 % alcohol, five ml lidocaine 2%, five mg dexamethasone will be injected in each side of the aorta after aspiration to exclude intravascular or subarachnoid injection.
arm group label: CT group (CTCPN group)
arm group type: Active Comparator
description: CT guided celiac plexus neurolysis After one week of the operation and the patient completely awake, the patient will be transferred to CT lab. The procedure will be done after attachment of basic monitors and transfusion of 500 ml saline in 20 G cannula before starting the procedure and the patient will be given 5 mg midazolam as a sedation. The procedure will be done by anesthetist and radiologist who had a good experience in celiac plexus neurolysis. In our study we will use the classic posterior bilateral approach. The patient will be in the prone position. After sterilization of the back by chlorohixidine 10 % , subcutaneous injection of 5 ml lidocaine as a local anaesthesia until a wheel will be formed then the procedure will be done. We will use 20 G Chiba needle under guidance of CT. Twenty ml of 95% alcohol , five ml lidocaine 2 % and five mg dexamethasone in each side of the aorta after aspiaration to exclude intravascular injection and subarachnoid injection
intervention type: Procedure
intervention name: Intraoperative celiac plexus neurolysis
description: neurolysis of celiac plexus by intraoperative techniques
arm group label: intraoperative group (IOCPN group)
intervention type: Procedure
intervention name: CT guided celiac plexus neurolysis
description: Neurolysis of celiac plexus percutaneously by CT guidance
arm group label: CT group (CTCPN group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Tarek M. Shams, MD
role: Study Director
affiliation: : Professor of Anesthesia and Surgical Intensive Care
last name: Mahmoud M. Elsedeiq, MSc
role: Principal Investigator
affiliation: assistan lecturer of Anesthesia and Surgical Intensive Care
last name: Mohamed A. Ghanim, MD
role: Study Chair
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
last name: Ibrahim I. Abd El-basir, MD
role: Study Chair
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: Undecided