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/NCT06024343</url>
    </required_header>
    <id_info>
      <org_study_id>CSPAC-MEN-1</org_study_id>
      <nct_id>NCT06024343</nct_id>
    </id_info>
    <brief_title>Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Repair or Reconstruction</brief_title>
    <official_title>Long-term Prognosis and Quality of Life in Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Repair or Reconstruction: A Multicenter Prospective Single-Arm Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Third Affiliated Hospital of Soochow University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tongji Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chinese PLA General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Affiliated Hospital of Xuzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fudan University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to evaluate the impact of concomitant main pancreatic duct repair or&#xD;
        reconstruction during minimally invasive pancreatic tumor enucleation on long-term patient&#xD;
        prognosis and quality of life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Standard surgical procedures for benign or low-grade malignant pancreatic tumors is&#xD;
        associated with increased risks of postoperative complications and long-term pancreatic&#xD;
        functional impairment, while parenchyma-sparing pancreatectomy such as enucleation can reduce&#xD;
        the incidence of complications and preserve healthy parenchyma, thereby preserve both&#xD;
        endocrine and exocrine pancreatic function. It has been reported that pancreatic tumor&#xD;
        enucleation is a safe and feasible approach in preserving normal physiological function in&#xD;
        patients undergoing pancreatic surgery.&#xD;
  &#xD;
        With the growing emphasis on routine screenings and the application of high-quality&#xD;
        thin-slice imaging techniques, the detection rates of pancreatic tumors have witnessed a&#xD;
        steady increase. Additionally, there is a notable trend towards younger patients being&#xD;
        diagnosed with pancreatic tumors. Consequently, in conjunction with ensuring safe and&#xD;
        thorough tumor resection while maximizing preservation of pancreatic function, there is a&#xD;
        current clinical demand to further reduce surgical trauma.&#xD;
  &#xD;
        Literature reviews and meta-analyses have demonstrated that minimally invasive enucleation&#xD;
        procedures offer well-known advantages associated with minimally invasive approaches, such as&#xD;
        shorter postoperative hospital stays and lower overall complication rates. While the&#xD;
        occurrence rate of severe complications, such as postoperative hemorrhage, remains relatively&#xD;
        low, the development of postoperative pancreatic fistula (POPF) continues to pose a&#xD;
        challenging issue.&#xD;
  &#xD;
        The distance between the tumor and the main pancreatic duct (MPD) is considered a crucial&#xD;
        factor influencing the occurrence of POPF after enucleation. However, these data have been&#xD;
        rarely described in previous studies, making it challenging to accurately assess their actual&#xD;
        impact on the rate of POPF occurrence. Heeger et al. suggested that the risk of POPF&#xD;
        increases with closer proximity of the tumor to the MPD. The incidence of POPF was higher in&#xD;
        deep-seated tumors after pancreatic enucleation (distance to MPD &lt;3 mm) compared to&#xD;
        superficial tumors (&gt;3 mm) (73.3% vs. 30.0%, P=0.002). Other studies have even limited this&#xD;
        critical distance to 2mm. Some research has indicated that if the tumor invades or encases&#xD;
        the MPD, enucleation surgery should be contraindicated, and standard resection should be&#xD;
        preferred to avoid the risk of POPF postoperatively. However, a retrospective analysis by&#xD;
        Strobel et al. on 166 cases of pancreatic tumor enucleation demonstrated that even tumors in&#xD;
        close proximity to the MPD can be safely resected, although their study did not include cases&#xD;
        with tumor encasement of the MPD. In 2021, Professor Liu Rong and colleagues introduced the&#xD;
        concept of pancreatic duct surgery and outlined four main surgical approaches: MPD repair,&#xD;
        pancreatic end-to-end anastomosis, local excision of branch-duct intraductal papillary&#xD;
        mucinous neoplasms, and MPD replacement. However, detailed research data in this field are&#xD;
        still lacking.&#xD;
  &#xD;
        The safety and feasibility of minimally invasive pancreatic tumor enucleation procedures&#xD;
        involving MPD repair or reconstruction, the control of POPF, and the long-term prognosis and&#xD;
        quality of life of patients after MPD repair or reconstruction remain unclear. Therefore,&#xD;
        this study aims to conduct a prospective, multicenter, single-arm clinical trial. The results&#xD;
        of this study will serve as a valuable reference for clinical practice and promote the&#xD;
        development and application of minimally invasive pancreatic tumor enucleation procedures.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Clinically Relevant Postoperative Pancreatic Fistula</measure>
      <time_frame>Within 90 days after surgery.</time_frame>
      <description>Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Perioperative complication rate according to the Clavien-Dindo classification</measure>
      <time_frame>Within 90 days after surgery.</time_frame>
      <description>Adverse events that occur during or after the surgery, reported according to the Clavien-Dindo classification.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative pancreatic hemorrhage (PPH) rate</measure>
      <time_frame>Within 90 days after surgery.</time_frame>
      <description>Postoperative pancreatic hemorrhage (PPH) rate within 90 days after surgery, reported according to the ISGPS definition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delayed gastric emptying (DGE) rate</measure>
      <time_frame>Within 90 days after surgery.</time_frame>
      <description>Delayed gastric emptying (DGE) rate within 90 days after surgery, reported according to the ISGPS definition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reoperation rate</measure>
      <time_frame>Within 90 days after surgery.</time_frame>
      <description>Reoperation rate within 90 days after surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of pancreatic enzyme-dependent malabsorption</measure>
      <time_frame>Through study completion, an average of 3 year.</time_frame>
      <description>Postoperative pancreatic enzyme-dependent malabsorption rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of new-onset diabetes</measure>
      <time_frame>Through study completion, an average of 3 year.</time_frame>
      <description>Postoperative new-onset diabetes rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Life quality satisfaction evaluated according to EORTC C30 scale</measure>
      <time_frame>Through study completion, an average of 3 year.</time_frame>
      <description>The patient's health-related quality of life after surgical intervention. It includes physical, emotional, and social aspects of a patient's well-being. This study evaluated quality of life using a telephone survey and the EORTC C30 scales.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>R0 resection rate</measure>
      <time_frame>From the date of surgery to 1 month after surgery.</time_frame>
      <description>R0 margin rate on postoperative pathological assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrence-free survival (RFS)</measure>
      <time_frame>Through study completion, an average of 3 year.</time_frame>
      <description>The time of surgery to the time of tumor recurrence or death.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">112</enrollment>
    <condition>Pancreatic Tumor, Benign</condition>
    <condition>Pancreatic Neuroendocrine Tumor</condition>
    <condition>Solid Pseudopapillary Tumor of the Pancreas</condition>
    <arm_group>
      <arm_group_label>MPD Repair or Reconstruction</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In laparoscopic or robotic pancreatic tumor enucleation, it is inevitable that the main pancreatic duct (MPD) may be damaged due to its proximity or encasement by the tumor. After tumor resection, MPD repair or reconstruction can be performed. If there is no associated MPD dilation, a MPD stent can be inserted and secured with interrupted sutures. When placing the stent, it is important to ensure that the distal end of the stent passes through the duodenal papilla to sufficiently reduce the pressure inside the MPD. Vascular remnants or branch pancreatic duct remnants on the pancreatic resection surface should be sutured. After hemostasis, efforts should be made to restore the serosalization of the pancreatic resection surface. The surface can also be left exposed or covered with ligamentum teres hepatis. Fish-mouth-shaped incisions can be closed, but care should be taken to avoid creating dead spaces that may lead to fluid accumulation and hinder drainage.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>MPD Repair or Reconstruction</intervention_name>
      <description>During laparoscopic or robotic pancreatic tumor enucleation, if the main pancreatic duct (MPD) is damaged due to its proximity or encasement by the tumor, MPD repair or reconstruction is performed.</description>
      <arm_group_label>MPD Repair or Reconstruction</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age between 18 and 70 years, regardless of gender.&#xD;
  &#xD;
            2. Solitary benign or low-grade malignant tumor of the pancreas.&#xD;
  &#xD;
            3. Patients evaluated according to guidelines indicating the need for surgery or strongly&#xD;
               requesting surgery.&#xD;
  &#xD;
            4. Feasibility of performing minimally invasive pancreatic tumor enucleation based on&#xD;
               preoperative imaging evaluation.&#xD;
  &#xD;
            5. Intraoperative procedure involving repair or reconstruction of the main pancreatic&#xD;
               duct.&#xD;
  &#xD;
            6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or&#xD;
               1.&#xD;
  &#xD;
            7. Willingness to comply with the study's follow-up plan and other protocol requirements.&#xD;
  &#xD;
            8. Voluntary participation and signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Body mass index (BMI) &gt; 35 kg/m2.&#xD;
  &#xD;
            2. Individuals planning pregnancy, currently pregnant, or breastfeeding.&#xD;
  &#xD;
            3. History of major abdominal surgery.&#xD;
  &#xD;
            4. Concurrent presence of other malignant tumors.&#xD;
  &#xD;
            5. Intraoperative frozen pathology or postoperative pathology indicating the tumor to be&#xD;
               malignant, requiring curative resection instead.&#xD;
  &#xD;
            6. Severe impairment of cardiac, hepatic, or renal function (e.g., NYHA class 3-4 heart&#xD;
               failure, ALT and/or AST levels exceeding three times the upper limit of normal,&#xD;
               creatinine levels exceeding the upper limit of normal).&#xD;
  &#xD;
            7. Participation in other clinical trials simultaneously.&#xD;
  &#xD;
          Withdrawal Criteria:&#xD;
  &#xD;
            1. Significant changes in the participant's condition after enrollment that render the&#xD;
               study protocol unsuitable or infeasible.&#xD;
  &#xD;
            2. Occurrence of severe complications that impact the implementation of the study plan.&#xD;
  &#xD;
            3. Identification of technical difficulties after enrollment, making the studied&#xD;
               treatment protocol impossible to implement.&#xD;
  &#xD;
            4. Emergent need for treatment due to other diseases confirmed after enrollment.&#xD;
  &#xD;
            5. Deviation from the study protocol in the actual administration of treatment.&#xD;
  &#xD;
            6. Voluntary withdrawal or discontinuation of any examinations, treatments, and&#xD;
               monitoring required by the study at any stage, for personal reasons of the&#xD;
               participant.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xianjun Yu, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xiaowu Xu, MD</last_name>
      <role>Study Director</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xianjun Yu, MD, PhD</last_name>
      <phone>+86-13801669875</phone>
      <email>yuxianjun@fudanpci.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zheng Li, MD</last_name>
      <phone>+86-18521097686</phone>
      <email>lizheng@fudanpci.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xianjun Yu, MD, PhD</last_name>
        <phone>+86-13801669875</phone>
        <email>yuxianjun@fudanpci.org</email>
      </contact>
      <investigator>
        <last_name>Xianjun Yu, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Xiaowu Xu, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <link>
      <url>https://doi.org/10.1016/j.isurg.2022.11.001</url>
      <description>In 2021, Professor Liu Rong and colleagues introduced the concept of pancreatic duct surgery for the first time and outlined four main surgical approaches.</description>
    </link>
    <reference>
      <citation>Cauley CE, Pitt HA, Ziegler KM, Nakeeb A, Schmidt CM, Zyromski NJ, House MG, Lillemoe KD. Pancreatic enucleation: improved outcomes compared to resection. J Gastrointest Surg. 2012 Jul;16(7):1347-53. doi: 10.1007/s11605-012-1893-7. Epub 2012 Apr 24.</citation>
      <PMID>22528577</PMID>
    </reference>
    <reference>
      <citation>Giuliani T, De Pastena M, Paiella S, Marchegiani G, Landoni L, Festini M, Ramera M, Marinelli V, Casetti L, Esposito A, Bassi C, Salvia R. Pancreatic Enucleation Patients Share the Same Quality of Life as the General Population at Long-Term Follow-Up: A Propensity Score-Matched Analysis. Ann Surg. 2023 Mar 1;277(3):e609-e616. doi: 10.1097/SLA.0000000000004911. Epub 2021 Apr 14.</citation>
      <PMID>33856383</PMID>
    </reference>
    <reference>
      <citation>Kromrey ML, Bulow R, Hubner J, Paperlein C, Lerch MM, Ittermann T, Volzke H, Mayerle J, Kuhn JP. Prospective study on the incidence, prevalence and 5-year pancreatic-related mortality of pancreatic cysts in a population-based study. Gut. 2018 Jan;67(1):138-145. doi: 10.1136/gutjnl-2016-313127. Epub 2017 Sep 6.</citation>
      <PMID>28877981</PMID>
    </reference>
    <reference>
      <citation>van Huijgevoort NCM, Del Chiaro M, Wolfgang CL, van Hooft JE, Besselink MG. Diagnosis and management of pancreatic cystic neoplasms: current evidence and guidelines. Nat Rev Gastroenterol Hepatol. 2019 Nov;16(11):676-689. doi: 10.1038/s41575-019-0195-x. Epub 2019 Sep 16.</citation>
      <PMID>31527862</PMID>
    </reference>
    <reference>
      <citation>Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.</citation>
      <PMID>28448665</PMID>
    </reference>
    <reference>
      <citation>Zhou Y, Zhao M, Wu L, Ye F, Si X. Short- and long-term outcomes after enucleation of pancreatic tumors: An evidence-based assessment. Pancreatology. 2016 Nov-Dec;16(6):1092-1098. doi: 10.1016/j.pan.2016.07.006. Epub 2016 Jul 9.</citation>
      <PMID>27423534</PMID>
    </reference>
    <reference>
      <citation>Guerra F, Giuliani G, Bencini L, Bianchi PP, Coratti A. Minimally invasive versus open pancreatic enucleation. Systematic review and meta-analysis of surgical outcomes. J Surg Oncol. 2018 Jun;117(7):1509-1516. doi: 10.1002/jso.25026. Epub 2018 Mar 25.</citation>
      <PMID>29574729</PMID>
    </reference>
    <reference>
      <citation>Dalla Valle R, Cremaschi E, Lamecchi L, Guerini F, Rosso E, Iaria M. Open and minimally invasive pancreatic neoplasms enucleation: a systematic review. Surg Endosc. 2019 Oct;33(10):3192-3199. doi: 10.1007/s00464-019-06967-9. Epub 2019 Jul 30.</citation>
      <PMID>31363894</PMID>
    </reference>
    <reference>
      <citation>Shukla PJ, Barreto SG, Shrikhande SV. Enucleation of pancreatic neoplasms (Br J Surg 2007; 94: 1254-1259). Br J Surg. 2008 Feb;95(2):261; author reply 261-2. doi: 10.1002/bjs.6148. No abstract available.</citation>
      <PMID>18196559</PMID>
    </reference>
    <reference>
      <citation>Brient C, Regenet N, Sulpice L, Brunaud L, Mucci-Hennekine S, Carrere N, Milin J, Ayav A, Pradere B, Hamy A, Bresler L, Meunier B, Mirallie E. Risk factors for postoperative pancreatic fistulization subsequent to enucleation. J Gastrointest Surg. 2012 Oct;16(10):1883-7. doi: 10.1007/s11605-012-1971-x. Epub 2012 Aug 8.</citation>
      <PMID>22872510</PMID>
    </reference>
    <reference>
      <citation>Bartolini I, Bencini L, Bernini M, Farsi M, Calistri M, Annecchiarico M, Moraldi L, Coratti A. Robotic enucleations of pancreatic benign or low-grade malignant tumors: preliminary results and comparison with robotic demolitive resections. Surg Endosc. 2019 Sep;33(9):2834-2842. doi: 10.1007/s00464-018-6576-3. Epub 2018 Nov 12.</citation>
      <PMID>30421079</PMID>
    </reference>
    <reference>
      <citation>Ei S, Mihaljevic AL, Kulu Y, Kaiser J, Hinz U, Buchler MW, Hackert T. Enucleation for benign or borderline tumors of the pancreas: comparing open and minimally invasive surgery. HPB (Oxford). 2021 Jun;23(6):921-926. doi: 10.1016/j.hpb.2020.10.001. Epub 2020 Oct 18.</citation>
      <PMID>33087306</PMID>
    </reference>
    <reference>
      <citation>Zhang RC, Zhou YC, Mou YP, Huang CJ, Jin WW, Yan JF, Wang YX, Liao Y. Laparoscopic versus open enucleation for pancreatic neoplasms: clinical outcomes and pancreatic function analysis. Surg Endosc. 2016 Jul;30(7):2657-65. doi: 10.1007/s00464-015-4538-6. Epub 2015 Oct 20.</citation>
      <PMID>26487211</PMID>
    </reference>
    <reference>
      <citation>Strobel O, Cherrez A, Hinz U, Mayer P, Kaiser J, Fritz S, Schneider L, Klauss M, Buchler MW, Hackert T. Risk of pancreatic fistula after enucleation of pancreatic tumours. Br J Surg. 2015 Sep;102(10):1258-66. doi: 10.1002/bjs.9843. Epub 2015 Jun 24.</citation>
      <PMID>26109380</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Xian-Jun Yu</investigator_full_name>
      <investigator_title>President of Fudan University Shanghai Cancer Center</investigator_title>
    </responsible_party>
    <keyword>Pancreatic benign or low-grade malignant tumors</keyword>
    <keyword>Minimally invasive enucleation</keyword>
    <keyword>Main Pancreatic Duct Repair or Reconstruction</keyword>
    <keyword>Long-term prognosis</keyword>
    <keyword>Quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Neuroendocrine Tumors</mesh_term>
      <mesh_term>Pancreatic Neoplasms</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/NCT06024343
  org study id: CSPAC-MEN-1
  nct id: NCT06024343
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the impact of concomitant main pancreatic duct repair or
        reconstruction during minimally invasive pancreatic tumor enucleation on long-term patient
        prognosis and quality of life.
  Standard surgical procedures for benign or low-grade malignant pancreatic tumors is
        associated with increased risks of postoperative complications and long-term pancreatic
        functional impairment, while parenchyma-sparing pancreatectomy such as enucleation can reduce
        the incidence of complications and preserve healthy parenchyma, thereby preserve both
        endocrine and exocrine pancreatic function. It has been reported that pancreatic tumor
        enucleation is a safe and feasible approach in preserving normal physiological function in
        patients undergoing pancreatic surgery.
  
        With the growing emphasis on routine screenings and the application of high-quality
        thin-slice imaging techniques, the detection rates of pancreatic tumors have witnessed a
        steady increase. Additionally, there is a notable trend towards younger patients being
        diagnosed with pancreatic tumors. Consequently, in conjunction with ensuring safe and
        thorough tumor resection while maximizing preservation of pancreatic function, there is a
        current clinical demand to further reduce surgical trauma.
  
        Literature reviews and meta-analyses have demonstrated that minimally invasive enucleation
        procedures offer well-known advantages associated with minimally invasive approaches, such as
        shorter postoperative hospital stays and lower overall complication rates. While the
        occurrence rate of severe complications, such as postoperative hemorrhage, remains relatively
        low, the development of postoperative pancreatic fistula (POPF) continues to pose a
        challenging issue.
  
        The distance between the tumor and the main pancreatic duct (MPD) is considered a crucial
        factor influencing the occurrence of POPF after enucleation. However, these data have been
        rarely described in previous studies, making it challenging to accurately assess their actual
        impact on the rate of POPF occurrence. Heeger et al. suggested that the risk of POPF
        increases with closer proximity of the tumor to the MPD. The incidence of POPF was higher in
        deep-seated tumors after pancreatic enucleation (distance to MPD <3 mm) compared to
        superficial tumors (>3 mm) (73.3% vs. 30.0%, P=0.002). Other studies have even limited this
        critical distance to 2mm. Some research has indicated that if the tumor invades or encases
        the MPD, enucleation surgery should be contraindicated, and standard resection should be
        preferred to avoid the risk of POPF postoperatively. However, a retrospective analysis by
        Strobel et al. on 166 cases of pancreatic tumor enucleation demonstrated that even tumors in
        close proximity to the MPD can be safely resected, although their study did not include cases
        with tumor encasement of the MPD. In 2021, Professor Liu Rong and colleagues introduced the
        concept of pancreatic duct surgery and outlined four main surgical approaches: MPD repair,
        pancreatic end-to-end anastomosis, local excision of branch-duct intraductal papillary
        mucinous neoplasms, and MPD replacement. However, detailed research data in this field are
        still lacking.
  
        The safety and feasibility of minimally invasive pancreatic tumor enucleation procedures
        involving MPD repair or reconstruction, the control of POPF, and the long-term prognosis and
        quality of life of patients after MPD repair or reconstruction remain unclear. Therefore,
        this study aims to conduct a prospective, multicenter, single-arm clinical trial. The results
        of this study will serve as a valuable reference for clinical practice and promote the
        development and application of minimally invasive pancreatic tumor enucleation procedures.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of Clinically Relevant Postoperative Pancreatic Fistula
  time frame: Within 90 days after surgery.
  description: Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.
  measure: Perioperative complication rate according to the Clavien-Dindo classification
  time frame: Within 90 days after surgery.
  description: Adverse events that occur during or after the surgery, reported according to the Clavien-Dindo classification.
  measure: Postoperative pancreatic hemorrhage (PPH) rate
  time frame: Within 90 days after surgery.
  description: Postoperative pancreatic hemorrhage (PPH) rate within 90 days after surgery, reported according to the ISGPS definition.
  measure: Delayed gastric emptying (DGE) rate
  time frame: Within 90 days after surgery.
  description: Delayed gastric emptying (DGE) rate within 90 days after surgery, reported according to the ISGPS definition.
  measure: Reoperation rate
  time frame: Within 90 days after surgery.
  description: Reoperation rate within 90 days after surgery.
  measure: Rate of pancreatic enzyme-dependent malabsorption
  time frame: Through study completion, an average of 3 year.
  description: Postoperative pancreatic enzyme-dependent malabsorption rate.
  measure: Rate of new-onset diabetes
  time frame: Through study completion, an average of 3 year.
  description: Postoperative new-onset diabetes rate.
  measure: Life quality satisfaction evaluated according to EORTC C30 scale
  time frame: Through study completion, an average of 3 year.
  description: The patient's health-related quality of life after surgical intervention. It includes physical, emotional, and social aspects of a patient's well-being. This study evaluated quality of life using a telephone survey and the EORTC C30 scales.
  measure: R0 resection rate
  time frame: From the date of surgery to 1 month after surgery.
  description: R0 margin rate on postoperative pathological assessment.
  measure: Recurrence-free survival (RFS)
  time frame: Through study completion, an average of 3 year.
  description: The time of surgery to the time of tumor recurrence or death.
  arm group label: MPD Repair or Reconstruction
  arm group type: Experimental
  description: In laparoscopic or robotic pancreatic tumor enucleation, it is inevitable that the main pancreatic duct (MPD) may be damaged due to its proximity or encasement by the tumor. After tumor resection, MPD repair or reconstruction can be performed. If there is no associated MPD dilation, a MPD stent can be inserted and secured with interrupted sutures. When placing the stent, it is important to ensure that the distal end of the stent passes through the duodenal papilla to sufficiently reduce the pressure inside the MPD. Vascular remnants or branch pancreatic duct remnants on the pancreatic resection surface should be sutured. After hemostasis, efforts should be made to restore the serosalization of the pancreatic resection surface. The surface can also be left exposed or covered with ligamentum teres hepatis. Fish-mouth-shaped incisions can be closed, but care should be taken to avoid creating dead spaces that may lead to fluid accumulation and hinder drainage.
  intervention type: Procedure
  intervention name: MPD Repair or Reconstruction
  description: During laparoscopic or robotic pancreatic tumor enucleation, if the main pancreatic duct (MPD) is damaged due to its proximity or encasement by the tumor, MPD repair or reconstruction is performed.
  arm group label: MPD Repair or Reconstruction
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Xianjun Yu, MD, PhD
  role: Principal Investigator
  affiliation: Fudan University
  last name: Xiaowu Xu, MD
  role: Study Director
  affiliation: Fudan University
  last name: Xianjun Yu, MD, PhD
  phone: +86-13801669875
  email: yuxianjun@fudanpci.org
  last name: Zheng Li, MD
  phone: +86-18521097686
  email: lizheng@fudanpci.org
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: China
  url: https://doi.org/10.1016/j.isurg.2022.11.001
  description: In 2021, Professor Liu Rong and colleagues introduced the concept of pancreatic duct surgery for the first time and outlined four main surgical approaches.
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  PMID: 22528577
  citation: Giuliani T, De Pastena M, Paiella S, Marchegiani G, Landoni L, Festini M, Ramera M, Marinelli V, Casetti L, Esposito A, Bassi C, Salvia R. Pancreatic Enucleation Patients Share the Same Quality of Life as the General Population at Long-Term Follow-Up: A Propensity Score-Matched Analysis. Ann Surg. 2023 Mar 1;277(3):e609-e616. doi: 10.1097/SLA.0000000000004911. Epub 2021 Apr 14.
  PMID: 33856383
  citation: Kromrey ML, Bulow R, Hubner J, Paperlein C, Lerch MM, Ittermann T, Volzke H, Mayerle J, Kuhn JP. Prospective study on the incidence, prevalence and 5-year pancreatic-related mortality of pancreatic cysts in a population-based study. Gut. 2018 Jan;67(1):138-145. doi: 10.1136/gutjnl-2016-313127. Epub 2017 Sep 6.
  PMID: 28877981
  citation: van Huijgevoort NCM, Del Chiaro M, Wolfgang CL, van Hooft JE, Besselink MG. Diagnosis and management of pancreatic cystic neoplasms: current evidence and guidelines. Nat Rev Gastroenterol Hepatol. 2019 Nov;16(11):676-689. doi: 10.1038/s41575-019-0195-x. Epub 2019 Sep 16.
  PMID: 31527862
  citation: Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.
  PMID: 28448665
  citation: Zhou Y, Zhao M, Wu L, Ye F, Si X. Short- and long-term outcomes after enucleation of pancreatic tumors: An evidence-based assessment. Pancreatology. 2016 Nov-Dec;16(6):1092-1098. doi: 10.1016/j.pan.2016.07.006. Epub 2016 Jul 9.
  PMID: 27423534
  citation: Guerra F, Giuliani G, Bencini L, Bianchi PP, Coratti A. Minimally invasive versus open pancreatic enucleation. Systematic review and meta-analysis of surgical outcomes. J Surg Oncol. 2018 Jun;117(7):1509-1516. doi: 10.1002/jso.25026. Epub 2018 Mar 25.
  PMID: 29574729
  citation: Dalla Valle R, Cremaschi E, Lamecchi L, Guerini F, Rosso E, Iaria M. Open and minimally invasive pancreatic neoplasms enucleation: a systematic review. Surg Endosc. 2019 Oct;33(10):3192-3199. doi: 10.1007/s00464-019-06967-9. Epub 2019 Jul 30.
  PMID: 31363894
  citation: Shukla PJ, Barreto SG, Shrikhande SV. Enucleation of pancreatic neoplasms (Br J Surg 2007; 94: 1254-1259). Br J Surg. 2008 Feb;95(2):261; author reply 261-2. doi: 10.1002/bjs.6148. No abstract available.
  PMID: 18196559
  citation: Brient C, Regenet N, Sulpice L, Brunaud L, Mucci-Hennekine S, Carrere N, Milin J, Ayav A, Pradere B, Hamy A, Bresler L, Meunier B, Mirallie E. Risk factors for postoperative pancreatic fistulization subsequent to enucleation. J Gastrointest Surg. 2012 Oct;16(10):1883-7. doi: 10.1007/s11605-012-1971-x. Epub 2012 Aug 8.
  PMID: 22872510
  citation: Bartolini I, Bencini L, Bernini M, Farsi M, Calistri M, Annecchiarico M, Moraldi L, Coratti A. Robotic enucleations of pancreatic benign or low-grade malignant tumors: preliminary results and comparison with robotic demolitive resections. Surg Endosc. 2019 Sep;33(9):2834-2842. doi: 10.1007/s00464-018-6576-3. Epub 2018 Nov 12.
  PMID: 30421079
  citation: Ei S, Mihaljevic AL, Kulu Y, Kaiser J, Hinz U, Buchler MW, Hackert T. Enucleation for benign or borderline tumors of the pancreas: comparing open and minimally invasive surgery. HPB (Oxford). 2021 Jun;23(6):921-926. doi: 10.1016/j.hpb.2020.10.001. Epub 2020 Oct 18.
  PMID: 33087306
  citation: Zhang RC, Zhou YC, Mou YP, Huang CJ, Jin WW, Yan JF, Wang YX, Liao Y. Laparoscopic versus open enucleation for pancreatic neoplasms: clinical outcomes and pancreatic function analysis. Surg Endosc. 2016 Jul;30(7):2657-65. doi: 10.1007/s00464-015-4538-6. Epub 2015 Oct 20.
  PMID: 26487211
  citation: Strobel O, Cherrez A, Hinz U, Mayer P, Kaiser J, Fritz S, Schneider L, Klauss M, Buchler MW, Hackert T. Risk of pancreatic fistula after enucleation of pancreatic tumours. Br J Surg. 2015 Sep;102(10):1258-66. doi: 10.1002/bjs.9843. Epub 2015 Jun 24.
  PMID: 26109380
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Xian-Jun Yu
  investigator title: President of Fudan University Shanghai Cancer Center
  mesh term: Neoplasms
  mesh term: Neuroendocrine Tumors
  mesh term: Pancreatic Neoplasms
  sharing ipd: No