<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/NCT04443595</url>
  </required_header>
  <id_info>
    <org_study_id>2020-009-1</org_study_id>
    <nct_id>NCT04443595</nct_id>
  </id_info>
  <brief_title>Dual-scopic Pancreatic Necrosectomy (DPN)</brief_title>
  <official_title>Dual-scopic Pancreatic Necrosectomy (DPN): Laparoscopic Pancreatic Necrosectomy (LPN) and Nephroscopic Pancreatic Necrosectomy (NPN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First People's Hospital of Hangzhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First People's Hospital of Hangzhou</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The LPN procedure is performed under general anesthesia. The transperitoneal access to&#xD;
      peripancreatic space is via the gastro-colic ligament and greater omentum, effusion and pus&#xD;
      is removed by laparoscopic forceps and suction. Laparoscopic cholecystectomy (LC) is&#xD;
      performed during the LPN procedure on patients with indication.&#xD;
&#xD;
      The NPN procedure is followed by the standard retroperitoneal approach. After the catheter is&#xD;
      exchanged over a guide wire and serially dilated up from 6F to 24F followed by Seldinger&#xD;
      technique, the access track to the necrotic cavity is established. A nephroscope is inserted&#xD;
      into the cavity through the track for debridement. Using forceps and suction, the&#xD;
      peripancreatic solid necrotic tissue and pus is grasped and removed. A large-bore irrigating&#xD;
      drain is left in the cavity, with continuous irrigation by warm normal saline solution at a&#xD;
      rate of 100-125 ml/h after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complication Rate</measure>
    <time_frame>through study completion, an average of 24 weeks</time_frame>
    <description>Proportion of patients with perioperative complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>through study completion, an average of 24 weeks</time_frame>
    <description>Proportion of patients dying in the perioperative period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>through study completion, an average of 24 weeks</time_frame>
    <description>Length of hospital stay</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pancreatitis</condition>
  <condition>Pancreatitis, Acute Necrotizing</condition>
  <condition>Pancreatic Diseases</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment of Acute Severe Pancreatitis with DPN</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dual-scopic pancreatic necrosectomy（DPN）</intervention_name>
    <description>Treatment of Acute Severe Pancreatitis with DPN</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients ages 18 or above admitted to UPMC with a diagnosis of AP based on at&#xD;
             least 2 of the following criteria:(i) abdominal pain characteristic of AP (ii) serum&#xD;
             amylase and/or lipase ≥ 3 times the upper limit of normal (iii) characteristic&#xD;
             findings of AP on abdominal CT scan will be screened for study enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Presence of renal dysfunction (Cr&gt;1.5mg/dL)&#xD;
&#xD;
          -  Pre existing heart dysfunction or NYHA classification score above III&#xD;
&#xD;
          -  Coagulation 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_contact>
    <last_name>Yang Cai</last_name>
    <phone>+8613867136969</phone>
    <email>caiyang6969@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hangzhou First People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhe Jiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang Cai</last_name>
      <phone>+8613867136969</phone>
      <email>caiyang6969@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First People's Hospital of Hangzhou</investigator_affiliation>
    <investigator_full_name>Yang Cai</investigator_full_name>
    <investigator_title>Director, Deputy Chief of Hepatobiliary and Pancreatic Surgery, Professor.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatic Diseases</mesh_term>
    <mesh_term>Pancreatitis, Acute Necrotizing</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04443595
org study id: 2020-009-1
nct id: NCT04443595
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The LPN procedure is performed under general anesthesia. The transperitoneal access to
      peripancreatic space is via the gastro-colic ligament and greater omentum, effusion and pus
      is removed by laparoscopic forceps and suction. Laparoscopic cholecystectomy (LC) is
      performed during the LPN procedure on patients with indication.

      The NPN procedure is followed by the standard retroperitoneal approach. After the catheter is
      exchanged over a guide wire and serially dilated up from 6F to 24F followed by Seldinger
      technique, the access track to the necrotic cavity is established. A nephroscope is inserted
      into the cavity through the track for debridement. Using forceps and suction, the
      peripancreatic solid necrotic tissue and pus is grasped and removed. A large-bore irrigating
      drain is left in the cavity, with continuous irrigation by warm normal saline solution at a
      rate of 100-125 ml/h after surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complication Rate
time frame: through study completion, an average of 24 weeks
description: Proportion of patients with perioperative complications
measure: Mortality
time frame: through study completion, an average of 24 weeks
description: Proportion of patients dying in the perioperative period
measure: Hospital stay
time frame: through study completion, an average of 24 weeks
description: Length of hospital stay
arm group label: Experimental
arm group type: Experimental
description: Treatment of Acute Severe Pancreatitis with DPN
intervention type: Procedure
intervention name: Dual-scopic pancreatic necrosectomy（DPN）
description: Treatment of Acute Severe Pancreatitis with DPN
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yang Cai
phone: +8613867136969
email: caiyang6969@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First People's Hospital of Hangzhou
investigator full name: Yang Cai
investigator title: Director, Deputy Chief of Hepatobiliary and Pancreatic Surgery, Professor.
mesh term: Pancreatitis
mesh term: Pancreatic Diseases
mesh term: Pancreatitis, Acute Necrotizing
sharing ipd: No