<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/NCT04418739</url>
  </required_header>
  <id_info>
    <org_study_id>JEP-2019-796</org_study_id>
    <nct_id>NCT04418739</nct_id>
  </id_info>
  <brief_title>Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes</brief_title>
  <official_title>Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Kebangsaan Malaysia Medical Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Kebangsaan Malaysia Medical Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay&#xD;
      treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes&#xD;
      are broadly categorized to disease-related, patient-related and operative factors. Whereas an&#xD;
      inexhaustible list of study exists on looking at reducing PD complication rates with respect&#xD;
      to the above-mentioned factors, it was only recently that more attention has been given to&#xD;
      the impact of perioperative and intraoperative fluid regimes on PD outcomes. This study takes&#xD;
      interest in the impact of intraoperative fluid regimes on PD outcomes. The objective of this&#xD;
      investigation is to compare the outcomes with the use of intraoperative intravenous human&#xD;
      albumin versus standard intraoperative fluid regimes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled trial being conducted at the Universiti Kebangsaan Malaysia&#xD;
      Medical Center (UKMMC) with two arms; the control and treatment arms. The treatment arm will&#xD;
      receive intravenous human albumin intraoperatively whilst the control arm will receive&#xD;
      standard intraoperative fluid regimes. Primary endpoint will be overall complication rates&#xD;
      whilst secondary endpoints are length of hospitalization, length of ICU care, duration of&#xD;
      gastroparesis, pancreatic fistula rates, surgical site infection rates, duration of surgery&#xD;
      and intraoperative bleeding.&#xD;
&#xD;
      Beyond the intraoperative fluid regimes, postoperative care follows the standardised UKMMC&#xD;
      Enhanced Recovery After Surgery (ERAS) protocols which saw an improvement in overall outcomes&#xD;
      in patients who underwent pancreaticoduodenectomies (PD). Preoperative care will include&#xD;
      nutrition optimisation, counselling, antimicrobial prophylaxis, perioperative glycemic&#xD;
      control and near-zero fluid balance.&#xD;
&#xD;
      Data collection will include:&#xD;
&#xD;
      i. preoperative data: age, sex, ethnicity, BMI on admission, date of admission, comorbidities&#xD;
      and the New York Heart Association (NYHA) functional status classification. Further&#xD;
      information will include biochemical markers such as serum albumin albumin, white cell count&#xD;
      (WCC), renal functions.&#xD;
&#xD;
      ii. Intraoperative information: duration of surgery, estimated blood loss, pancreatic duct&#xD;
      size, pancreatic texture, amount and type of fluid administered, fluid balances and type of&#xD;
      anastomoses.&#xD;
&#xD;
      iii. postoperative data: fluid balances and renal function of postoperative day 1 to 3,&#xD;
      duration of ICU stay, readmission to ICU, length of hospital stay, duration to standard&#xD;
      feeds, grading of pancreatic fistula (where relevant), surgical site infection, duration to&#xD;
      removal of urinary catheter, cardiac complications, renal and pulmonary complications, deep&#xD;
      vein thrombosis, re-operation, and mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 27, 2020</start_date>
  <completion_date type="Anticipated">November 26, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 26, 2022</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>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a randomized controlled trial conducted at the University Kebangsaan Malaysia Medical Center (UKMMC) with two arms; a control a treatment arm. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Complications</measure>
    <time_frame>Postoperative complications are recorded from date of surgery to date of documented complications including death, assessed from date of surgery to date of discharge or death, whichever came earlier, for up to 12 months.</time_frame>
    <description>Complications are defined as any deviation from the normal postoperative course, graded from I to V following the Clavien-Dindo classification of complications whereby Grade I are mild complications not needing any additional interventions and Grade V equates to the most severe complication which is death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months</time_frame>
    <description>Duration of days of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months</time_frame>
    <description>Duration of stay in ICU (in days), where relevant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Pancreatic Fistula (POPF) rates</measure>
    <time_frame>From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months</time_frame>
    <description>Rates of postoperative pancreatic fistula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delayed Gastric Emptying</measure>
    <time_frame>From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months</time_frame>
    <description>Rates of prolonged gastroparesis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of surgery</measure>
    <time_frame>Duration is measured from the start time till the end time of surgery and will be assessed at the end of surgery for up to 12 months</time_frame>
    <description>Measured in duration of surgery (in hours &amp; mins)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">122</enrollment>
  <condition>Pancreaticoduodenectomy</condition>
  <condition>Pancreatic Fistula</condition>
  <condition>Delayed Gastric Emptying</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Anastomotic Leak</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard intraoperative fluid regime</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous human albumin 1g/kg at skin incision running at 100ml/hour</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Human albumin</intervention_name>
    <description>Intravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing pancreaticoduodenectomy that can consent to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known allergy to human albumin&#xD;
&#xD;
          -  Patients of American Society of Anaesthesiologist (ASA) physical status class 3 and&#xD;
             above.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian Chik</last_name>
    <role>Study Chair</role>
    <affiliation>Universiti Kebangsaan Malaysia Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ian Chik</last_name>
    <phone>+60123243404</phone>
    <email>ianchikmd@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah I Liew</last_name>
    <phone>+601112218229</phone>
    <email>liew4689@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universiti Kebangsaan Malaysia Medical Center</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ian Chik</last_name>
      <phone>+60123243404</phone>
      <email>ianchikmd@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sarah I Liew, MBBS</last_name>
      <phone>+601112218229</phone>
      <email>liew4689@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ian Chik</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Farrah-Hani Imran</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Azarinah Izaham</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zamri Zuhdi</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Azlanuddin Azman</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Razman Jarmin</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sarah I Liew</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fahrol F Jaafar</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <results_reference>
    <citation>Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. doi: 10.1097/01.sla.0000094387.50865.23.</citation>
    <PMID>14578723</PMID>
  </results_reference>
  <results_reference>
    <citation>Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.</citation>
    <PMID>15273542</PMID>
  </results_reference>
  <results_reference>
    <citation>Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; ERAS(R) Society; European Society for Clinical Nutrition and Metabolism; International Association for Surgical Metabolism and Nutrition. Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):817-30. doi: 10.1016/j.clnu.2012.08.011. Epub 2012 Sep 26.</citation>
    <PMID>23079762</PMID>
  </results_reference>
  <results_reference>
    <citation>Lavu H, Sell NM, Carter TI, Winter JM, Maguire DP, Gratch DM, Berman RA, Feil MG, Grunwald Z, Leiby BE, Pequignot EC, Rosato EL, Yeo CJ. The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy. Ann Surg. 2014 Sep;260(3):445-53; discussion 453-5. doi: 10.1097/SLA.0000000000000872.</citation>
    <PMID>25115420</PMID>
  </results_reference>
  <results_reference>
    <citation>Boldt J. Use of albumin: an update. Br J Anaesth. 2010 Mar;104(3):276-84. doi: 10.1093/bja/aep393. Epub 2010 Jan 24.</citation>
    <PMID>20100698</PMID>
  </results_reference>
  <results_reference>
    <citation>Ring J, Messmer K. Incidence and severity of anaphylactoid reactions to colloid volume substitutes. Lancet. 1977 Feb 26;1(8009):466-9. doi: 10.1016/s0140-6736(77)91953-5.</citation>
    <PMID>65572</PMID>
  </results_reference>
  <results_reference>
    <citation>Ling, Q. Y., Ariffin, A. C., Azman, A., Zuhdi, Z., Othman, H., &amp; Jarmin, R. (2017). Early postoperative outcomes for pancreaticoduodenectomy before and after implementation of enhanced recovery after surgery (ERAS) protocol. Surgical Chronicles, 22(3), 109-113</citation>
  </results_reference>
  <results_reference>
    <citation>Soar J, Pumphrey R, Cant A, Clarke S, Corbett A, Dawson P, Ewan P, Foex B, Gabbott D, Griffiths M, Hall J, Harper N, Jewkes F, Maconochie I, Mitchell S, Nasser S, Nolan J, Rylance G, Sheikh A, Unsworth DJ, Warrell D; Working Group of the Resuscitation Council (UK). Emergency treatment of anaphylactic reactions--guidelines for healthcare providers. Resuscitation. 2008 May;77(2):157-69. doi: 10.1016/j.resuscitation.2008.02.001. Epub 2008 Mar 20.</citation>
    <PMID>18358585</PMID>
  </results_reference>
  <results_reference>
    <citation>Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.</citation>
    <PMID>28040257</PMID>
  </results_reference>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Laxenaire MC, Charpentier C, Feldman L. [Anaphylactoid reactions to colloid plasma substitutes: incidence, risk factors, mechanisms. A French multicenter prospective study]. Ann Fr Anesth Reanim. 1994;13(3):301-10. doi: 10.1016/s0750-7658(94)80038-3. French.</citation>
    <PMID>7992937</PMID>
  </results_reference>
  <results_reference>
    <citation>Fischer M, Matsuo K, Gonen M, Grant F, Dematteo RP, D'Angelica MI, Mascarenhas J, Brennan MF, Allen PJ, Blumgart LH, Jarnagin WR. Relationship between intraoperative fluid administration and perioperative outcome after pancreaticoduodenectomy: results of a prospective randomized trial of acute normovolemic hemodilution compared with standard intraoperative management. Ann Surg. 2010 Dec;252(6):952-8. doi: 10.1097/SLA.0b013e3181ff36b1.</citation>
    <PMID>21107104</PMID>
  </results_reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>March 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 15, 2022</last_update_submitted>
  <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreaticoduodenectomy</keyword>
  <keyword>Postoperative Pancreatic Fistula</keyword>
  <keyword>Pancreatic Cancer</keyword>
  <keyword>Intravenous Human Albumin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Pancreatic Fistula</mesh_term>
    <mesh_term>Gastroparesis</mesh_term>
    <mesh_term>Fistula</mesh_term>
    <mesh_term>Anastomotic Leak</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 11, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04418739
org study id: JEP-2019-796
nct id: NCT04418739
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay
      treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes
      are broadly categorized to disease-related, patient-related and operative factors. Whereas an
      inexhaustible list of study exists on looking at reducing PD complication rates with respect
      to the above-mentioned factors, it was only recently that more attention has been given to
      the impact of perioperative and intraoperative fluid regimes on PD outcomes. This study takes
      interest in the impact of intraoperative fluid regimes on PD outcomes. The objective of this
      investigation is to compare the outcomes with the use of intraoperative intravenous human
      albumin versus standard intraoperative fluid regimes.
This is a randomized controlled trial being conducted at the Universiti Kebangsaan Malaysia
      Medical Center (UKMMC) with two arms; the control and treatment arms. The treatment arm will
      receive intravenous human albumin intraoperatively whilst the control arm will receive
      standard intraoperative fluid regimes. Primary endpoint will be overall complication rates
      whilst secondary endpoints are length of hospitalization, length of ICU care, duration of
      gastroparesis, pancreatic fistula rates, surgical site infection rates, duration of surgery
      and intraoperative bleeding.

      Beyond the intraoperative fluid regimes, postoperative care follows the standardised UKMMC
      Enhanced Recovery After Surgery (ERAS) protocols which saw an improvement in overall outcomes
      in patients who underwent pancreaticoduodenectomies (PD). Preoperative care will include
      nutrition optimisation, counselling, antimicrobial prophylaxis, perioperative glycemic
      control and near-zero fluid balance.

      Data collection will include:

      i. preoperative data: age, sex, ethnicity, BMI on admission, date of admission, comorbidities
      and the New York Heart Association (NYHA) functional status classification. Further
      information will include biochemical markers such as serum albumin albumin, white cell count
      (WCC), renal functions.

      ii. Intraoperative information: duration of surgery, estimated blood loss, pancreatic duct
      size, pancreatic texture, amount and type of fluid administered, fluid balances and type of
      anastomoses.

      iii. postoperative data: fluid balances and renal function of postoperative day 1 to 3,
      duration of ICU stay, readmission to ICU, length of hospital stay, duration to standard
      feeds, grading of pancreatic fistula (where relevant), surgical site infection, duration to
      removal of urinary catheter, cardiac complications, renal and pulmonary complications, deep
      vein thrombosis, re-operation, and mortality.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized controlled trial conducted at the University Kebangsaan Malaysia Medical Center (UKMMC) with two arms; a control a treatment arm. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes.
primary purpose: Prevention
masking: Single (Participant)
measure: Overall Complications
time frame: Postoperative complications are recorded from date of surgery to date of documented complications including death, assessed from date of surgery to date of discharge or death, whichever came earlier, for up to 12 months.
description: Complications are defined as any deviation from the normal postoperative course, graded from I to V following the Clavien-Dindo classification of complications whereby Grade I are mild complications not needing any additional interventions and Grade V equates to the most severe complication which is death.
measure: Length of Hospital Stay
time frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
description: Duration of days of hospitalization
measure: Length of ICU stay
time frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
description: Duration of stay in ICU (in days), where relevant
measure: Postoperative Pancreatic Fistula (POPF) rates
time frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
description: Rates of postoperative pancreatic fistula
measure: Delayed Gastric Emptying
time frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
description: Rates of prolonged gastroparesis
measure: Ease of surgery
time frame: Duration is measured from the start time till the end time of surgery and will be assessed at the end of surgery for up to 12 months
description: Measured in duration of surgery (in hours & mins)
arm group label: Control Arm
arm group type: No Intervention
description: Standard intraoperative fluid regime
arm group label: Treatment Arm
arm group type: Experimental
description: Intravenous human albumin 1g/kg at skin incision running at 100ml/hour
intervention type: Drug
intervention name: Human albumin
description: Intravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour
arm group label: Treatment Arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ian Chik
role: Study Chair
affiliation: Universiti Kebangsaan Malaysia Medical Center
last name: Ian Chik
phone: +60123243404
email: ianchikmd@gmail.com
last name: Sarah I Liew
phone: +601112218229
email: liew4689@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Malaysia
citation: Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. doi: 10.1097/01.sla.0000094387.50865.23.
PMID: 14578723
citation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PMID: 15273542
citation: Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; ERAS(R) Society; European Society for Clinical Nutrition and Metabolism; International Association for Surgical Metabolism and Nutrition. Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):817-30. doi: 10.1016/j.clnu.2012.08.011. Epub 2012 Sep 26.
PMID: 23079762
citation: Lavu H, Sell NM, Carter TI, Winter JM, Maguire DP, Gratch DM, Berman RA, Feil MG, Grunwald Z, Leiby BE, Pequignot EC, Rosato EL, Yeo CJ. The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy. Ann Surg. 2014 Sep;260(3):445-53; discussion 453-5. doi: 10.1097/SLA.0000000000000872.
PMID: 25115420
citation: Boldt J. Use of albumin: an update. Br J Anaesth. 2010 Mar;104(3):276-84. doi: 10.1093/bja/aep393. Epub 2010 Jan 24.
PMID: 20100698
citation: Ring J, Messmer K. Incidence and severity of anaphylactoid reactions to colloid volume substitutes. Lancet. 1977 Feb 26;1(8009):466-9. doi: 10.1016/s0140-6736(77)91953-5.
PMID: 65572
citation: Ling, Q. Y., Ariffin, A. C., Azman, A., Zuhdi, Z., Othman, H., & Jarmin, R. (2017). Early postoperative outcomes for pancreaticoduodenectomy before and after implementation of enhanced recovery after surgery (ERAS) protocol. Surgical Chronicles, 22(3), 109-113
citation: Soar J, Pumphrey R, Cant A, Clarke S, Corbett A, Dawson P, Ewan P, Foex B, Gabbott D, Griffiths M, Hall J, Harper N, Jewkes F, Maconochie I, Mitchell S, Nasser S, Nolan J, Rylance G, Sheikh A, Unsworth DJ, Warrell D; Working Group of the Resuscitation Council (UK). Emergency treatment of anaphylactic reactions--guidelines for healthcare providers. Resuscitation. 2008 May;77(2):157-69. doi: 10.1016/j.resuscitation.2008.02.001. Epub 2008 Mar 20.
PMID: 18358585
citation: Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
PMID: 28040257
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: Laxenaire MC, Charpentier C, Feldman L. [Anaphylactoid reactions to colloid plasma substitutes: incidence, risk factors, mechanisms. A French multicenter prospective study]. Ann Fr Anesth Reanim. 1994;13(3):301-10. doi: 10.1016/s0750-7658(94)80038-3. French.
PMID: 7992937
citation: Fischer M, Matsuo K, Gonen M, Grant F, Dematteo RP, D'Angelica MI, Mascarenhas J, Brennan MF, Allen PJ, Blumgart LH, Jarnagin WR. Relationship between intraoperative fluid administration and perioperative outcome after pancreaticoduodenectomy: results of a prospective randomized trial of acute normovolemic hemodilution compared with standard intraoperative management. Ann Surg. 2010 Dec;252(6):952-8. doi: 10.1097/SLA.0b013e3181ff36b1.
PMID: 21107104
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Pancreatic Fistula
mesh term: Gastroparesis
mesh term: Fistula
mesh term: Anastomotic Leak
sharing ipd: No
submitted: January 11, 2023