xml: <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/NCT06023771</url>
    </required_header>
    <id_info>
      <org_study_id>K4433</org_study_id>
      <nct_id>NCT06023771</nct_id>
    </id_info>
    <brief_title>Invasive Intervention of Local Complications of Acute Pancreatitis</brief_title>
    <official_title>Drainage and Debridement of Local Complications of Acute Pancreatitis: A Single-center Real-world Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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>
        Strategies for invasive intervention in acute pancreatitis include sequential or combined use&#xD;
        of multiple drainage and debridement modalities. The more widely used is the step-up&#xD;
        approach, which requires an individualized and multidisciplinary (internal medicine,&#xD;
        interventional radiology, endoscopy, surgery, critical care medicine, and nutritionists)&#xD;
        approach. The available evidence from randomized controlled studies is from highly selected&#xD;
        subject populations, and it is unclear whether the results can be applied to complex clinical&#xD;
        situations in real clinics, and the optimal strategy for drainage of peripancreatic lesions&#xD;
        in different patients still needs to be evaluated in the real world. This study intends to&#xD;
        establish a prospective single-center cohort for real-world analysis to collect comprehensive&#xD;
        clinic information and clinical outcomes, to evaluate the effectiveness and safety of&#xD;
        existing intervention strategies, especially the timing and modality of interventions, in&#xD;
        real-world clinical practice, and to explore the key factors affecting patient prognosis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2026</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>Major complications or death</measure>
      <time_frame>Day 1 from admission until 6 months after discharge</time_frame>
      <description>A composite of major complications (i.e., new-onset multiple organ failure or systemic complications, enterocutaneous fistula or perforation of a visceral organ requiring intervention, or intraabdominal bleeding requiring intervention) or death during admission or during the 6 months after discharge.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Organ failure</measure>
      <time_frame>Day 1 from admission until 6 months after discharge</time_frame>
      <description>New-onset ( not present at any time in the 24 hours before first intervention) pulmonary failure, circulatory failure, or renal failure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systemic complication</measure>
      <time_frame>Day 1 from admission until 6 months after discharge</time_frame>
      <description>New-onset ( not present at any time in the 24 hours before first intervention) systematic complications such as disseminated intravascular coagulation, severe metabolic disturbance, and gastrointestinal bleeding</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Enterocutaneous fistula</measure>
      <time_frame>Day 1 from admission until 6 months after discharge</time_frame>
      <description>Secretion of fecal material from a percutaneous drain or drainage canal after removal of drains or from a surgical wound, either from small or large bowel; confirmed by imaging or during surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perforation of visceral organ</measure>
      <time_frame>Day 1 from admission until 6 months after discharge</time_frame>
      <description>Perforation requiring surgical, radiologic, or endoscopic intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraabdominal bleeding</measure>
      <time_frame>Day 1 from admission until 6 months after discharge</time_frame>
      <description>Requiring surgical, radiologic, or endoscopic intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pancreatic fistula</measure>
      <time_frame>Day 1 from admission until 6 months after discharge</time_frame>
      <description>Output, through a percutaneous drain or drainage canal after removal of drains or from a surgical wound, of any measurable volume of fluid with an amylase content &gt;3 times the serum amylase level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>New-onset diabetes</measure>
      <time_frame>Day 1 from admission until 6 months after discharge</time_frame>
      <description>Insulin or oral antidiabetic drugs required 6 mo after discharge; this requirement was not present before onset of pancreatitis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of pancreatic enzymes</measure>
      <time_frame>Day 1 from admission until 6 months after discharge</time_frame>
      <description>Oral pancreatic-enzyme supplementation required to treat clinical symptoms of steatorrhea 6 mo after discharge; this requirement was not present before onset of pancreatitis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospitalization</measure>
      <time_frame>Day 1 from admission until the 1 day of discharge</time_frame>
      <description>Total days of hospitalization for the management of acute pancreatitis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of intesive care</measure>
      <time_frame>Day 1 from admission until the 1 day of discharge</time_frame>
      <description>Total days in intesive care unit for the management of acute pancreatitis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total direct medical costs and indirect costs</measure>
      <time_frame>Day 1 from admission until the 1 day of discharge</time_frame>
      <description>Total direct medical costs and indirect costs during admission</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Acute Pancreatitis</condition>
    <arm_group>
      <arm_group_label>Acute pancreatitis requiring invasive intervention</arm_group_label>
      <description>Single-center cohort of acute pancreatitis patients requiring invasive intervention for the treatment of local complications during the whole course of disease.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Invasive intervention for acute pancreatitis</intervention_name>
      <description>Invasive interventions include drainage (endoscopic transmural drainage, imaging-guided percutaneous catheter drainage) and debridement (endoscopic debridement, videoscopic assisted retroperitoneal debridement, laparoscopic surgical debridement, open surgical debridement).</description>
      <arm_group_label>Acute pancreatitis requiring invasive intervention</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Hospitalized acute pancreatitis patients requiring invasive interventions.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Admission diagnosis of acute pancreatitis;&#xD;
  &#xD;
            -  Localized complications confirmed by imaging examinations;&#xD;
  &#xD;
            -  Voluntary participation in the study and signing of an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Improved with conservative treatment without invasive interventions for local&#xD;
               complications during hospitalization.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dong Wu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dong Wu</last_name>
      <phone>18612671010</phone>
      <email>wudong@pumch.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dong Wu</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 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>Pancreatitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023771
  org study id: K4433
  nct id: NCT06023771
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Strategies for invasive intervention in acute pancreatitis include sequential or combined use
        of multiple drainage and debridement modalities. The more widely used is the step-up
        approach, which requires an individualized and multidisciplinary (internal medicine,
        interventional radiology, endoscopy, surgery, critical care medicine, and nutritionists)
        approach. The available evidence from randomized controlled studies is from highly selected
        subject populations, and it is unclear whether the results can be applied to complex clinical
        situations in real clinics, and the optimal strategy for drainage of peripancreatic lesions
        in different patients still needs to be evaluated in the real world. This study intends to
        establish a prospective single-center cohort for real-world analysis to collect comprehensive
        clinic information and clinical outcomes, to evaluate the effectiveness and safety of
        existing intervention strategies, especially the timing and modality of interventions, in
        real-world clinical practice, and to explore the key factors affecting patient prognosis.
  observational model: Cohort
  time perspective: Prospective
  measure: Major complications or death
  time frame: Day 1 from admission until 6 months after discharge
  description: A composite of major complications (i.e., new-onset multiple organ failure or systemic complications, enterocutaneous fistula or perforation of a visceral organ requiring intervention, or intraabdominal bleeding requiring intervention) or death during admission or during the 6 months after discharge.
  measure: Organ failure
  time frame: Day 1 from admission until 6 months after discharge
  description: New-onset ( not present at any time in the 24 hours before first intervention) pulmonary failure, circulatory failure, or renal failure
  measure: Systemic complication
  time frame: Day 1 from admission until 6 months after discharge
  description: New-onset ( not present at any time in the 24 hours before first intervention) systematic complications such as disseminated intravascular coagulation, severe metabolic disturbance, and gastrointestinal bleeding
  measure: Enterocutaneous fistula
  time frame: Day 1 from admission until 6 months after discharge
  description: Secretion of fecal material from a percutaneous drain or drainage canal after removal of drains or from a surgical wound, either from small or large bowel; confirmed by imaging or during surgery
  measure: Perforation of visceral organ
  time frame: Day 1 from admission until 6 months after discharge
  description: Perforation requiring surgical, radiologic, or endoscopic intervention
  measure: Intraabdominal bleeding
  time frame: Day 1 from admission until 6 months after discharge
  description: Requiring surgical, radiologic, or endoscopic intervention
  measure: Pancreatic fistula
  time frame: Day 1 from admission until 6 months after discharge
  description: Output, through a percutaneous drain or drainage canal after removal of drains or from a surgical wound, of any measurable volume of fluid with an amylase content >3 times the serum amylase level
  measure: New-onset diabetes
  time frame: Day 1 from admission until 6 months after discharge
  description: Insulin or oral antidiabetic drugs required 6 mo after discharge; this requirement was not present before onset of pancreatitis
  measure: Use of pancreatic enzymes
  time frame: Day 1 from admission until 6 months after discharge
  description: Oral pancreatic-enzyme supplementation required to treat clinical symptoms of steatorrhea 6 mo after discharge; this requirement was not present before onset of pancreatitis
  measure: Length of hospitalization
  time frame: Day 1 from admission until the 1 day of discharge
  description: Total days of hospitalization for the management of acute pancreatitis
  measure: Length of intesive care
  time frame: Day 1 from admission until the 1 day of discharge
  description: Total days in intesive care unit for the management of acute pancreatitis
  measure: Total direct medical costs and indirect costs
  time frame: Day 1 from admission until the 1 day of discharge
  description: Total direct medical costs and indirect costs during admission
  arm group label: Acute pancreatitis requiring invasive intervention
  description: Single-center cohort of acute pancreatitis patients requiring invasive intervention for the treatment of local complications during the whole course of disease.
  intervention type: Procedure
  intervention name: Invasive intervention for acute pancreatitis
  description: Invasive interventions include drainage (endoscopic transmural drainage, imaging-guided percutaneous catheter drainage) and debridement (endoscopic debridement, videoscopic assisted retroperitoneal debridement, laparoscopic surgical debridement, open surgical debridement).
  arm group label: Acute pancreatitis requiring invasive intervention
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Dong Wu
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  last name: Dong Wu
  phone: 18612671010
  email: wudong@pumch.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Pancreatitis
  sharing ipd: No