<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/NCT02230436</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-GS02</org_study_id>
    <nct_id>NCT02230436</nct_id>
  </id_info>
  <brief_title>Early Versus Late Drain Removal After Pancreatectomy: A Randomized Prospective Trial</brief_title>
  <official_title>The Impact of Early Versus Late Drain Removal on Postoperative Morbidity After Pancreatectomy: A Randomized Prospective Trial</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>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to demonstrate the hypothesis that early removal of drain can reduce&#xD;
      the incidence of intra-abdominal infection and pancreatic fistula after pancreatectomy&#xD;
      compared with later removal of drain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to analyze the association between the time of removal of drain after&#xD;
      pancreatic resection and incidence of intra-abdominal complications, such as intra-abdominal&#xD;
      infection and pancreatic leakage. We design a prospective randomized study. Patients with&#xD;
      pancreatic and periampullar tumors who underwent pancreatoduodenectomy (PD) or distal&#xD;
      pancreatectomy (DP) are recruited to the study if amylase value in drain(s) is less than 5000&#xD;
      U/L on postoperative day (POD) 1. After obtaining informed consent, eligible patients are&#xD;
      randomly allocated to early or late drain removal group on POD 3. In the group A, drain(s)&#xD;
      are removed on POD 3, whereas in group B drain is removed on POD 4 or beyond. The primary&#xD;
      outcomes are the incidence of intra-abdominal infection and pancreatic fistula; the secondary&#xD;
      outcomes include intra-abdominal bleeding, delayed gastric emptying, pulmonary complications,&#xD;
      and length of hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intra-abdominal infection</measure>
    <time_frame>Up to postoperative 30 days</time_frame>
    <description>Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pancreatic fistula</measure>
    <time_frame>Up to postoperative 30 days</time_frame>
    <description>The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra-abdominal bleeding</measure>
    <time_frame>Up to postoperative 30 days</time_frame>
    <description>The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delayed gastric emptying</measure>
    <time_frame>Up to postoperative 30 days</time_frame>
    <description>The International Study Group of Pancreatic Surgery (ISGPS) definition: Inability to return to a standard diet by the end of the first postoperative week with prolonged nasogastric intubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary complications</measure>
    <time_frame>Up to postoperative 30 days</time_frame>
    <description>Including pulmonary infection and atelectasis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay (day)</measure>
    <time_frame>Up to postoperative 2 weeks</time_frame>
    <description>Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Pancreatectomy</condition>
  <condition>Post Procedural Discharge</condition>
  <arm_group>
    <arm_group_label>Early drain removal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Removing drain(s) on postoperative day 3 (n = 72)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late drain removal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Removing drain(s) on postoperative day 4 or later (n = 72)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early drain removal</intervention_name>
    <description>Removing drain(s) on postoperative day 3</description>
    <arm_group_label>Early drain removal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Late drain removal</intervention_name>
    <description>Removing drain(s) on postoperative day 4 or later</description>
    <arm_group_label>Late drain removal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: &gt;18yr, &lt;75yr&#xD;
&#xD;
          -  Patients with pancreatic diseases (including tumor and inflammatory disease) or&#xD;
             non-pancreatic tumors (biliary duct cancer or ampullary tumor) who underwent&#xD;
             pancreatoduodenectomy (PD) or distal pancreatectomy (DP)&#xD;
&#xD;
          -  The amylase value in drain(s) is less than 5000 U/L on postoperative day 1 and 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reconstruction of the pancreatic remnant by pancreaticogastrostomy&#xD;
&#xD;
          -  Intra-abdominal hemorrhage within 72 hours after operation&#xD;
&#xD;
          -  Biliary fistula (output of biliary fluid from at least 1 abdominal drain) within 72&#xD;
             hours after operation&#xD;
&#xD;
          -  Chylous leakage (milky water) within 72 hours after operation&#xD;
&#xD;
          -  The volume of drain effluent (ascites) is greater than 300 ml within 72 hours after&#xD;
             operation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Menghua Dai, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Menghua Dai, M.D.</last_name>
    <email>daim66@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ning Shi, M.D.</last_name>
    <phone>8613693303585</phone>
    <email>shining_doc@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Menghua Dai, M.D.</last_name>
      <email>daim66@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005.</citation>
    <PMID>17981197</PMID>
  </reference>
  <reference>
    <citation>Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.</citation>
    <PMID>16003309</PMID>
  </reference>
  <reference>
    <citation>Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Buchler MW. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007 Jul;142(1):20-5. doi: 10.1016/j.surg.2007.02.001.</citation>
    <PMID>17629996</PMID>
  </reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>February 20, 2017</last_update_submitted>
  <last_update_submitted_qc>February 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatectomy</keyword>
  <keyword>Time of drain removal</keyword>
  <!-- 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/NCT02230436
org study id: PUMCH-GS02
nct id: NCT02230436
lead sponsor: 
has dmc: Yes
The aim of this study is to demonstrate the hypothesis that early removal of drain can reduce
      the incidence of intra-abdominal infection and pancreatic fistula after pancreatectomy
      compared with later removal of drain.
This study is to analyze the association between the time of removal of drain after
      pancreatic resection and incidence of intra-abdominal complications, such as intra-abdominal
      infection and pancreatic leakage. We design a prospective randomized study. Patients with
      pancreatic and periampullar tumors who underwent pancreatoduodenectomy (PD) or distal
      pancreatectomy (DP) are recruited to the study if amylase value in drain(s) is less than 5000
      U/L on postoperative day (POD) 1. After obtaining informed consent, eligible patients are
      randomly allocated to early or late drain removal group on POD 3. In the group A, drain(s)
      are removed on POD 3, whereas in group B drain is removed on POD 4 or beyond. The primary
      outcomes are the incidence of intra-abdominal infection and pancreatic fistula; the secondary
      outcomes include intra-abdominal bleeding, delayed gastric emptying, pulmonary complications,
      and length of hospital stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intra-abdominal infection
time frame: Up to postoperative 30 days
description: Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
measure: Pancreatic fistula
time frame: Up to postoperative 30 days
description: The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
measure: Intra-abdominal bleeding
time frame: Up to postoperative 30 days
description: The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
measure: Delayed gastric emptying
time frame: Up to postoperative 30 days
description: The International Study Group of Pancreatic Surgery (ISGPS) definition: Inability to return to a standard diet by the end of the first postoperative week with prolonged nasogastric intubation.
measure: Pulmonary complications
time frame: Up to postoperative 30 days
description: Including pulmonary infection and atelectasis.
measure: Length of hospital stay (day)
time frame: Up to postoperative 2 weeks
description: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
arm group label: Early drain removal
arm group type: Experimental
description: Removing drain(s) on postoperative day 3 (n = 72)
arm group label: Late drain removal
arm group type: Experimental
description: Removing drain(s) on postoperative day 4 or later (n = 72)
intervention type: Other
intervention name: Early drain removal
description: Removing drain(s) on postoperative day 3
arm group label: Early drain removal
intervention type: Other
intervention name: Late drain removal
description: Removing drain(s) on postoperative day 4 or later
arm group label: Late drain removal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Menghua Dai, M.D.
role: Study Chair
affiliation: Peking Union Medical College Hospital
last name: Menghua Dai, M.D.
email: daim66@126.com
last name: Ning Shi, M.D.
phone: 8613693303585
email: shining_doc@163.com
facility: 
status: Recruiting
contact: 
country: China
citation: Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005.
PMID: 17981197
citation: Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
PMID: 16003309
citation: Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Buchler MW. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007 Jul;142(1):20-5. doi: 10.1016/j.surg.2007.02.001.
PMID: 17629996
responsible party type: Sponsor