<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/NCT04400357</url>
  </required_header>
  <id_info>
    <org_study_id>KY2020-93</org_study_id>
    <nct_id>NCT04400357</nct_id>
  </id_info>
  <brief_title>Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors</brief_title>
  <acronym>PORTAL</acronym>
  <official_title>Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors: A Multicenter Phase III Non-Inferiority Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Intuitive Surgical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ruijin Hospital</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multicenter randomized trial aims to primarily assess and compare the functional&#xD;
      recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and&#xD;
      malignant lesions of the head of the pancreas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PORTAL trial is a Phase 3 multicenter non-inferiority randomized controlled trial that&#xD;
      aims to address the question of feasibility and efficacy of the robotic minimally invasive&#xD;
      approach in pancreaticoduodenectomy.&#xD;
&#xD;
      In the past 10 years there has been an increasing number of retrospective series from major&#xD;
      centers for pancreatic surgery worldwide, that demonstrate similar and occasionally improved&#xD;
      postoperative outcomes in patients who undergo a robotic pancreaticoduodenectomy (Whipple).&#xD;
      The benefits of this minimally invasive approach appear to be decreased intraoperative&#xD;
      estimated blood loss, lower postoperative pain levels and smaller length of hospital stay,&#xD;
      whereas postoperative complications rates are comparable with the standard open approach.&#xD;
&#xD;
      This trial is conducted in multiple major centers for pancreatic surgery (open and robotic)&#xD;
      in China and aims to address these questions in a prospective fashion. All eligible patients&#xD;
      who present to these centers within the study period will be randomized in a 1:1 ratio to&#xD;
      either of the two arms (open vs. robotic). Patients enrolled in the study will be blinded&#xD;
      regarding the type of the procedure by application of identical wound dressings at the trocar&#xD;
      sites and the open incision. Patients will be followed up closely and will be evaluated&#xD;
      routinely for quality of life parameters for a period of at least 2 years postoperatively.&#xD;
      Additionally, patients who undergo surgery in either arm for pancreatic adenocarcinoma will&#xD;
      also be evaluated for time to adjuvant chemotherapy postoperatively, as well as recurrence&#xD;
      and survival data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 7, 2022</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to functional recovery postoperatively</measure>
    <time_frame>From date of surgery to date of functional recovery as described, assessed up to 90 days.</time_frame>
    <description>Daily evaluation of patient postoperative course will take place by the nursing and medical staff and will be documented by the study coordinators. Postoperative criteria that need to be fulfilled independently to achieve functional recovery status are the following:&#xD;
Discontinuation of intravenous or subcutaneous analgesia and preservation of adequate control levels (pain score)&#xD;
Early ambulation and restoration of mobility to an independent level (or to preoperative level if previously impaired)&#xD;
Ability to maintain sufficient oral caloric intake as defined by institutional dietitian services, without intravenous fluid support&#xD;
No clinical signs of active abdominal infection affecting the patient's performance status: absence of fever, white cell count and C-reactive protein decreasing towards normalization. The patient can be in oral antibiotics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients with pancreatic adenocarcinoma who achieve administration of adjuvant chemotherapy at 8 weeks postoperatively</measure>
    <time_frame>Postoperative Day 1 to Day 56</time_frame>
    <description>The number of patients who are fit and well to initiate adjuvant chemotherapy at the 8-week mark after the operation will be documented and compared between the two arms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>During surgery</time_frame>
    <description>Comparison of estimated blood loss (in ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>During surgery</time_frame>
    <description>Comparison of operative time (in minutes, from first incision to skin closure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complication rates and associated interventions</measure>
    <time_frame>Postoperative Day 1 to Day 30</time_frame>
    <description>Comparison of post-pancreatectomy morbidity between the two surgical approaches, that focus on:&#xD;
Pancreatic fistula&#xD;
Bile leak&#xD;
Chyle leak&#xD;
Delayed gastric emptying&#xD;
Surgical site infection&#xD;
Postoperative pancreatitis&#xD;
Postoperative hemorrhage&#xD;
Surgical site infections&#xD;
Other complications Additional documentation of re-intervention (radiological, endoscopic, or surgical) and re-admission rates, as well as postoperative hospital and ICU length of stay (time to discharge)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative mortality</measure>
    <time_frame>Postoperative Day 1 to Day 90</time_frame>
    <description>Comparison of mortality rates as a result of the pancreaticoduodenectomy in each arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measurements</measure>
    <time_frame>Postoperative Day 1 to Day 90</time_frame>
    <description>For assessment of postoperative quality of life (QoL) improvement, patients will be evaluated with the established EuqoQol EQ-5D-5L questionnaire, which is a self-reported assay focusing on five parameters: Pain/discomfort, anxiety/depression, usual activities, self-care, and mobility. Each of the five aforementioned parameters is scored from 0 to 5 (no issue, slight problem, moderate problem, severe problem, unable); patients also score independently their health status on a scale numbered from 0 to 100; 100 means the best health they can imagine, and 0 the worst.&#xD;
Answered questionnaires will be collected on postoperative days 1, 3, 5, 7, and afterwards every week until day 30. QoL evaluation will terminate at Day 90.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Margin resection status (R) in patients with pancreatic adenocarcinoma</measure>
    <time_frame>During surgery</time_frame>
    <description>In a sub-cohort of patients with pancreatic adenocarcinoma, the margin resection status (R) will be assessed and compared: R0 is defined as presence of tumor &gt;1mm from the resection margin, R1 as presence of tumor ≤1mm from the resection margin.&#xD;
Number of harvested lymph nodes&#xD;
Number of positive lymph nodes (infiltrated by tumor)&#xD;
Tumor size, degree of differentiation, perineural and lymphovascular invasion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in locoregional lymphadenectomy in patients with pancreatic adenocarcinoma</measure>
    <time_frame>During surgery</time_frame>
    <description>In a sub-cohort of patients with pancreatic adenocarcinoma, the number of harvested and positive lymph nodes (infiltrated by tumor) will be assessed and compared between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative recurrence in patients with pancreatic adenocarcinoma</measure>
    <time_frame>Postoperative Day 1 up to 5 years after surgery</time_frame>
    <description>Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document disease recurrence, defined as the re-presentation of measurable tumor after resection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative survival in patients with pancreatic adenocarcinoma</measure>
    <time_frame>Postoperative Day 1 up to 5 years after surgery</time_frame>
    <description>Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document overall survival, defined as the time between date of operation and date of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative costs</measure>
    <time_frame>Postoperative Day 1 to Day 90</time_frame>
    <description>Comparison of cost between the two groups, defined as the combination of intraoperative and postoperative costs, measured in US Dollars.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of operative approach on circulating biomarkers in the postoperative setting</measure>
    <time_frame>Postoperative Day 1 to Day 30</time_frame>
    <description>Enrolled patients in the study will be consented for peripheral blood draws in multiple time-points to assess the amount of circulating tumor DNA (ctDNA) and assess potential differences between the two groups in patients with pancreatic adenocarcinoma. The blood draws will occur: 1. immediately pre-operatively, 2. Postoperative days 2, 7, and 30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of perioperative inflammatory response (C-reactive protein)</measure>
    <time_frame>Day of surgery to Postoperative Day 7</time_frame>
    <description>Patients C-reactive protein (CRP, measured in ng/L) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of perioperative inflammatory response (Neutrophil-to-Lymphocyte ratio)</measure>
    <time_frame>Day of surgery to Postoperative Day 7</time_frame>
    <description>Patients neutrophil-to-lymphocyte ratio (NLR, defined as the division of absolute neutrophil number to absolute lymphocyte number) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of perioperative inflammatory response (Interleukin-6)</measure>
    <time_frame>Day of surgery to Postoperative Day 7</time_frame>
    <description>Patients Interleukin 6 (IL-6, measured in pg/mL) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">244</enrollment>
  <condition>Pancreatic Adenocarcinoma</condition>
  <condition>Pancreatic Cysts</condition>
  <condition>Pancreatic Endocrine Tumors</condition>
  <condition>Chronic Pancreatitis</condition>
  <condition>Cholangiocarcinoma, Extrahepatic</condition>
  <condition>Ampullary Adenocarcinoma</condition>
  <condition>Duodenal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Robotic pancreaticoduodenectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized in this arm will undergo a robotic pancreaticoduodenectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open pancreaticoduodenectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized in this arm will undergo a routine open pancreaticoduodenectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robotic pancreaticoduodenectomy</intervention_name>
    <description>Patients in this arm will undergo a pancreaticoduodenectomy with robotic-assisted techonology.</description>
    <arm_group_label>Robotic pancreaticoduodenectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open pancreaticoduodenectomy</intervention_name>
    <description>Patients in this arm will undergo an open pancreaticoduodenectomy which is the standard surgical approach.</description>
    <arm_group_label>Open pancreaticoduodenectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an indication for elective pancreaticoduodenectomy for malignant,&#xD;
             premalignant, and symptomatic benign disease in the pancreatic and periampullary&#xD;
             region&#xD;
&#xD;
          -  Performance status of 0/1 (assessed based on comorbidities using the Karnofsky score&#xD;
             and Malnutrition Universal Screening Tool score among others, especially for patients&#xD;
             with malignant disease)&#xD;
&#xD;
          -  Imaging with computed tomography and/or MRI pancreas performed within 8 weeks for&#xD;
             benign and 4 weeks for malignant disease; for the latter tumor staging with MRI liver,&#xD;
             CT chest, and Cancer Antigen 19-9 is also mandatory.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index &gt; 35 kg/m2&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous history of major abdominal surgery&#xD;
&#xD;
          -  Requirement for multivisceral resection (additional surgical resection)&#xD;
&#xD;
          -  Preoperative chemotherapy and/or radiotherapy (for patients with pancreatic&#xD;
             adenocarcinoma)&#xD;
&#xD;
          -  Involvement of major regional vessels by the tumor (portal and superior mesenteric&#xD;
             vein, superior mesenteric artery, hepatic artery, celiac artery) as defined by the&#xD;
             borderline resectable and locally advanced nomenclature&#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_official>
    <last_name>Baiyong Shen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiabin JIN, PhD</last_name>
    <phone>008618101870031</phone>
    <email>jjb11501@rjh.com.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Georgios Gemenetzis, MD</last_name>
    <email>georgios.gemenetzis@glasgow.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ruijin Hospital Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jiabin JIN, PhD</last_name>
      <phone>008602164370045</phone>
      <phone_ext>670904</phone_ext>
      <email>jjb11501@rjh.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Nassour I, Winters SB, Hoehn R, Tohme S, Adam MA, Bartlett DL, Lee KK, Paniccia A, Zureikat AH. Long-term oncologic outcomes of robotic and open pancreatectomy in a national cohort of pancreatic adenocarcinoma. J Surg Oncol. 2020 Aug;122(2):234-242. doi: 10.1002/jso.25958. Epub 2020 Apr 29.</citation>
    <PMID>32350882</PMID>
  </reference>
  <reference>
    <citation>Shi Y, Jin J, Qiu W, Weng Y, Wang J, Zhao S, Huo Z, Qin K, Wang Y, Chen H, Deng X, Peng C, Shen B. Short-term Outcomes After Robot-Assisted vs Open Pancreaticoduodenectomy After the Learning Curve. JAMA Surg. 2020 May 1;155(5):389-394. doi: 10.1001/jamasurg.2020.0021.</citation>
    <PMID>32129815</PMID>
  </reference>
  <reference>
    <citation>Podda M, Gerardi C, Di Saverio S, Marino MV, Davies RJ, Pellino G, Pisanu A. Robotic-assisted versus open pancreaticoduodenectomy for patients with benign and malignant periampullary disease: a systematic review and meta-analysis of short-term outcomes. Surg Endosc. 2020 Jun;34(6):2390-2409. doi: 10.1007/s00464-020-07460-4. Epub 2020 Feb 18.</citation>
    <PMID>32072286</PMID>
  </reference>
  <reference>
    <citation>Zureikat AH, Beane JD, Zenati MS, Al Abbas AI, Boone BA, Moser AJ, Bartlett DL, Hogg ME, Zeh HJ 3rd. 500 Minimally Invasive Robotic Pancreatoduodenectomies: One Decade of Optimizing Performance. Ann Surg. 2021 May 1;273(5):966-972. doi: 10.1097/SLA.0000000000003550.</citation>
    <PMID>31851003</PMID>
  </reference>
  <reference>
    <citation>Girgis MD, Zenati MS, King JC, Hamad A, Zureikat AH, Zeh HJ, Hogg ME. Oncologic Outcomes After Robotic Pancreatic Resections Are Not Inferior to Open Surgery. Ann Surg. 2021 Sep 1;274(3):e262-e268. doi: 10.1097/SLA.0000000000003615.</citation>
    <PMID>31663967</PMID>
  </reference>
  <reference>
    <citation>Shi Y, Wang W, Qiu W, Zhao S, Wang J, Weng Y, Huo Z, Jin J, Wang Y, Deng X, Shen B, Peng C. Learning Curve From 450 Cases of Robot-Assisted Pancreaticoduocectomy in a High-Volume Pancreatic Center: Optimization of Operative Procedure and a Retrospective Study. Ann Surg. 2021 Dec 1;274(6):e1277-e1283. doi: 10.1097/SLA.0000000000003664.</citation>
    <PMID>31651533</PMID>
  </reference>
  <reference>
    <citation>Zhao W, Liu C, Li S, Geng D, Feng Y, Sun M. Safety and efficacy for robot-assisted versus open pancreaticoduodenectomy and distal pancreatectomy: A systematic review and meta-analysis. Surg Oncol. 2018 Sep;27(3):468-478. doi: 10.1016/j.suronc.2018.06.001. Epub 2018 Jun 4.</citation>
    <PMID>30217304</PMID>
  </reference>
  <reference>
    <citation>McMillan MT, Zureikat AH, Hogg ME, Kowalsky SJ, Zeh HJ, Sprys MH, Vollmer CM Jr. A Propensity Score-Matched Analysis of Robotic vs Open Pancreatoduodenectomy on Incidence of Pancreatic Fistula. JAMA Surg. 2017 Apr 1;152(4):327-335. doi: 10.1001/jamasurg.2016.4755.</citation>
    <PMID>28030724</PMID>
  </reference>
  <reference>
    <citation>Zureikat AH, Postlewait LM, Liu Y, Gillespie TW, Weber SM, Abbott DE, Ahmad SA, Maithel SK, Hogg ME, Zenati M, Cho CS, Salem A, Xia B, Steve J, Nguyen TK, Keshava HB, Chalikonda S, Walsh RM, Talamonti MS, Stocker SJ, Bentrem DJ, Lumpkin S, Kim HJ, Zeh HJ 3rd, Kooby DA. A Multi-institutional Comparison of Perioperative Outcomes of Robotic and Open Pancreaticoduodenectomy. Ann Surg. 2016 Oct;264(4):640-9. doi: 10.1097/SLA.0000000000001869.</citation>
    <PMID>27433907</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 10, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>April 30, 2022</last_update_submitted>
  <last_update_submitted_qc>April 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>JIABIN JIN</investigator_full_name>
    <investigator_title>Attending Surgeon, Pancreatic Disease Center</investigator_title>
  </responsible_party>
  <keyword>pancreaticoduodenectomy</keyword>
  <keyword>Whipple</keyword>
  <keyword>robotic</keyword>
  <keyword>daVinci</keyword>
  <keyword>pancreatic cancer</keyword>
  <keyword>outcomes</keyword>
  <keyword>pancreatectomy</keyword>
  <keyword>functional recovery</keyword>
  <keyword>complications</keyword>
  <keyword>recurrence</keyword>
  <keyword>circulating tumor DNA</keyword>
  <keyword>perioperative inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Pancreatic Cyst</mesh_term>
    <mesh_term>Endocrine Gland Neoplasms</mesh_term>
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Chronic</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/NCT04400357
org study id: KY2020-93
nct id: NCT04400357
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This multicenter randomized trial aims to primarily assess and compare the functional
      recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and
      malignant lesions of the head of the pancreas.
The PORTAL trial is a Phase 3 multicenter non-inferiority randomized controlled trial that
      aims to address the question of feasibility and efficacy of the robotic minimally invasive
      approach in pancreaticoduodenectomy.

      In the past 10 years there has been an increasing number of retrospective series from major
      centers for pancreatic surgery worldwide, that demonstrate similar and occasionally improved
      postoperative outcomes in patients who undergo a robotic pancreaticoduodenectomy (Whipple).
      The benefits of this minimally invasive approach appear to be decreased intraoperative
      estimated blood loss, lower postoperative pain levels and smaller length of hospital stay,
      whereas postoperative complications rates are comparable with the standard open approach.

      This trial is conducted in multiple major centers for pancreatic surgery (open and robotic)
      in China and aims to address these questions in a prospective fashion. All eligible patients
      who present to these centers within the study period will be randomized in a 1:1 ratio to
      either of the two arms (open vs. robotic). Patients enrolled in the study will be blinded
      regarding the type of the procedure by application of identical wound dressings at the trocar
      sites and the open incision. Patients will be followed up closely and will be evaluated
      routinely for quality of life parameters for a period of at least 2 years postoperatively.
      Additionally, patients who undergo surgery in either arm for pancreatic adenocarcinoma will
      also be evaluated for time to adjuvant chemotherapy postoperatively, as well as recurrence
      and survival data.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time to functional recovery postoperatively
time frame: From date of surgery to date of functional recovery as described, assessed up to 90 days.
description: Daily evaluation of patient postoperative course will take place by the nursing and medical staff and will be documented by the study coordinators. Postoperative criteria that need to be fulfilled independently to achieve functional recovery status are the following:
Discontinuation of intravenous or subcutaneous analgesia and preservation of adequate control levels (pain score)
Early ambulation and restoration of mobility to an independent level (or to preoperative level if previously impaired)
Ability to maintain sufficient oral caloric intake as defined by institutional dietitian services, without intravenous fluid support
No clinical signs of active abdominal infection affecting the patient's performance status: absence of fever, white cell count and C-reactive protein decreasing towards normalization. The patient can be in oral antibiotics.
measure: Percentage of patients with pancreatic adenocarcinoma who achieve administration of adjuvant chemotherapy at 8 weeks postoperatively
time frame: Postoperative Day 1 to Day 56
description: The number of patients who are fit and well to initiate adjuvant chemotherapy at the 8-week mark after the operation will be documented and compared between the two arms
measure: Intraoperative blood loss
time frame: During surgery
description: Comparison of estimated blood loss (in ml)
measure: Operative time
time frame: During surgery
description: Comparison of operative time (in minutes, from first incision to skin closure)
measure: Postoperative complication rates and associated interventions
time frame: Postoperative Day 1 to Day 30
description: Comparison of post-pancreatectomy morbidity between the two surgical approaches, that focus on:
Pancreatic fistula
Bile leak
Chyle leak
Delayed gastric emptying
Surgical site infection
Postoperative pancreatitis
Postoperative hemorrhage
Surgical site infections
Other complications Additional documentation of re-intervention (radiological, endoscopic, or surgical) and re-admission rates, as well as postoperative hospital and ICU length of stay (time to discharge)
measure: Postoperative mortality
time frame: Postoperative Day 1 to Day 90
description: Comparison of mortality rates as a result of the pancreaticoduodenectomy in each arm
measure: Quality of life measurements
time frame: Postoperative Day 1 to Day 90
description: For assessment of postoperative quality of life (QoL) improvement, patients will be evaluated with the established EuqoQol EQ-5D-5L questionnaire, which is a self-reported assay focusing on five parameters: Pain/discomfort, anxiety/depression, usual activities, self-care, and mobility. Each of the five aforementioned parameters is scored from 0 to 5 (no issue, slight problem, moderate problem, severe problem, unable); patients also score independently their health status on a scale numbered from 0 to 100; 100 means the best health they can imagine, and 0 the worst.
Answered questionnaires will be collected on postoperative days 1, 3, 5, 7, and afterwards every week until day 30. QoL evaluation will terminate at Day 90.
measure: Margin resection status (R) in patients with pancreatic adenocarcinoma
time frame: During surgery
description: In a sub-cohort of patients with pancreatic adenocarcinoma, the margin resection status (R) will be assessed and compared: R0 is defined as presence of tumor >1mm from the resection margin, R1 as presence of tumor ≤1mm from the resection margin.
Number of harvested lymph nodes
Number of positive lymph nodes (infiltrated by tumor)
Tumor size, degree of differentiation, perineural and lymphovascular invasion
measure: Differences in locoregional lymphadenectomy in patients with pancreatic adenocarcinoma
time frame: During surgery
description: In a sub-cohort of patients with pancreatic adenocarcinoma, the number of harvested and positive lymph nodes (infiltrated by tumor) will be assessed and compared between the two groups.
measure: Postoperative recurrence in patients with pancreatic adenocarcinoma
time frame: Postoperative Day 1 up to 5 years after surgery
description: Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document disease recurrence, defined as the re-presentation of measurable tumor after resection.
measure: Postoperative survival in patients with pancreatic adenocarcinoma
time frame: Postoperative Day 1 up to 5 years after surgery
description: Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document overall survival, defined as the time between date of operation and date of death.
measure: Perioperative costs
time frame: Postoperative Day 1 to Day 90
description: Comparison of cost between the two groups, defined as the combination of intraoperative and postoperative costs, measured in US Dollars.
measure: Effect of operative approach on circulating biomarkers in the postoperative setting
time frame: Postoperative Day 1 to Day 30
description: Enrolled patients in the study will be consented for peripheral blood draws in multiple time-points to assess the amount of circulating tumor DNA (ctDNA) and assess potential differences between the two groups in patients with pancreatic adenocarcinoma. The blood draws will occur: 1. immediately pre-operatively, 2. Postoperative days 2, 7, and 30.
measure: Comparison of perioperative inflammatory response (C-reactive protein)
time frame: Day of surgery to Postoperative Day 7
description: Patients C-reactive protein (CRP, measured in ng/L) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.
measure: Comparison of perioperative inflammatory response (Neutrophil-to-Lymphocyte ratio)
time frame: Day of surgery to Postoperative Day 7
description: Patients neutrophil-to-lymphocyte ratio (NLR, defined as the division of absolute neutrophil number to absolute lymphocyte number) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.
measure: Comparison of perioperative inflammatory response (Interleukin-6)
time frame: Day of surgery to Postoperative Day 7
description: Patients Interleukin 6 (IL-6, measured in pg/mL) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.
arm group label: Robotic pancreaticoduodenectomy
arm group type: Experimental
description: Patients randomized in this arm will undergo a robotic pancreaticoduodenectomy.
arm group label: Open pancreaticoduodenectomy
arm group type: Active Comparator
description: Patients randomized in this arm will undergo a routine open pancreaticoduodenectomy.
intervention type: Procedure
intervention name: Robotic pancreaticoduodenectomy
description: Patients in this arm will undergo a pancreaticoduodenectomy with robotic-assisted techonology.
arm group label: Robotic pancreaticoduodenectomy
intervention type: Procedure
intervention name: Open pancreaticoduodenectomy
description: Patients in this arm will undergo an open pancreaticoduodenectomy which is the standard surgical approach.
arm group label: Open pancreaticoduodenectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Baiyong Shen, PhD
role: Principal Investigator
affiliation: Ruijin Hospital
last name: Jiabin JIN, PhD
phone: 008618101870031
email: jjb11501@rjh.com.cn
last name: Georgios Gemenetzis, MD
email: georgios.gemenetzis@glasgow.ac.uk
facility: 
status: Recruiting
contact: 
country: China
citation: Nassour I, Winters SB, Hoehn R, Tohme S, Adam MA, Bartlett DL, Lee KK, Paniccia A, Zureikat AH. Long-term oncologic outcomes of robotic and open pancreatectomy in a national cohort of pancreatic adenocarcinoma. J Surg Oncol. 2020 Aug;122(2):234-242. doi: 10.1002/jso.25958. Epub 2020 Apr 29.
PMID: 32350882
citation: Shi Y, Jin J, Qiu W, Weng Y, Wang J, Zhao S, Huo Z, Qin K, Wang Y, Chen H, Deng X, Peng C, Shen B. Short-term Outcomes After Robot-Assisted vs Open Pancreaticoduodenectomy After the Learning Curve. JAMA Surg. 2020 May 1;155(5):389-394. doi: 10.1001/jamasurg.2020.0021.
PMID: 32129815
citation: Podda M, Gerardi C, Di Saverio S, Marino MV, Davies RJ, Pellino G, Pisanu A. Robotic-assisted versus open pancreaticoduodenectomy for patients with benign and malignant periampullary disease: a systematic review and meta-analysis of short-term outcomes. Surg Endosc. 2020 Jun;34(6):2390-2409. doi: 10.1007/s00464-020-07460-4. Epub 2020 Feb 18.
PMID: 32072286
citation: Zureikat AH, Beane JD, Zenati MS, Al Abbas AI, Boone BA, Moser AJ, Bartlett DL, Hogg ME, Zeh HJ 3rd. 500 Minimally Invasive Robotic Pancreatoduodenectomies: One Decade of Optimizing Performance. Ann Surg. 2021 May 1;273(5):966-972. doi: 10.1097/SLA.0000000000003550.
PMID: 31851003
citation: Girgis MD, Zenati MS, King JC, Hamad A, Zureikat AH, Zeh HJ, Hogg ME. Oncologic Outcomes After Robotic Pancreatic Resections Are Not Inferior to Open Surgery. Ann Surg. 2021 Sep 1;274(3):e262-e268. doi: 10.1097/SLA.0000000000003615.
PMID: 31663967
citation: Shi Y, Wang W, Qiu W, Zhao S, Wang J, Weng Y, Huo Z, Jin J, Wang Y, Deng X, Shen B, Peng C. Learning Curve From 450 Cases of Robot-Assisted Pancreaticoduocectomy in a High-Volume Pancreatic Center: Optimization of Operative Procedure and a Retrospective Study. Ann Surg. 2021 Dec 1;274(6):e1277-e1283. doi: 10.1097/SLA.0000000000003664.
PMID: 31651533
citation: Zhao W, Liu C, Li S, Geng D, Feng Y, Sun M. Safety and efficacy for robot-assisted versus open pancreaticoduodenectomy and distal pancreatectomy: A systematic review and meta-analysis. Surg Oncol. 2018 Sep;27(3):468-478. doi: 10.1016/j.suronc.2018.06.001. Epub 2018 Jun 4.
PMID: 30217304
citation: McMillan MT, Zureikat AH, Hogg ME, Kowalsky SJ, Zeh HJ, Sprys MH, Vollmer CM Jr. A Propensity Score-Matched Analysis of Robotic vs Open Pancreatoduodenectomy on Incidence of Pancreatic Fistula. JAMA Surg. 2017 Apr 1;152(4):327-335. doi: 10.1001/jamasurg.2016.4755.
PMID: 28030724
citation: Zureikat AH, Postlewait LM, Liu Y, Gillespie TW, Weber SM, Abbott DE, Ahmad SA, Maithel SK, Hogg ME, Zenati M, Cho CS, Salem A, Xia B, Steve J, Nguyen TK, Keshava HB, Chalikonda S, Walsh RM, Talamonti MS, Stocker SJ, Bentrem DJ, Lumpkin S, Kim HJ, Zeh HJ 3rd, Kooby DA. A Multi-institutional Comparison of Perioperative Outcomes of Robotic and Open Pancreaticoduodenectomy. Ann Surg. 2016 Oct;264(4):640-9. doi: 10.1097/SLA.0000000000001869.
PMID: 27433907
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: JIABIN JIN
investigator title: Attending Surgeon, Pancreatic Disease Center
mesh term: Adenocarcinoma
mesh term: Cholangiocarcinoma
mesh term: Pancreatic Cyst
mesh term: Endocrine Gland Neoplasms
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic
sharing ipd: No