<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/NCT03820531</url>
  </required_header>
  <id_info>
    <org_study_id>ZYSTEUS-Study</org_study_id>
    <nct_id>NCT03820531</nct_id>
  </id_info>
  <brief_title>DNA-mutation Analysis in Cyst Fluid of Suspected Intraductal Papillary Mucinous Neoplasia of the Pancreas</brief_title>
  <official_title>DNA-mutation Analysis by Next Generation Sequencing in Cyst Fluid of Suspected Intraductal Papillary Mucinous Neoplasia of the Pancreas Obtained by Endoscopic Ultrasound-guided Fine Needle Aspiration (ZYSTEUS-Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theresienkrankenhaus und St. Hedwig-Klinik GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital Heidelberg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Theresienkrankenhaus und St. Hedwig-Klinik GmbH</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diagnostic tools are needed to identify mucinous cysts for further evaluation or follow-up&#xD;
      respectively to identify cysts with HGD or invasive cancer at an early stage for surgical&#xD;
      resection. Molecular genetic analysis of pancreatic cyst fluid is a new but rapidly evolving&#xD;
      method to identify KRAS/GNAS oncogenic driver mutations in mucinous cysts and to identify&#xD;
      tumour suppressor gene mutations which are involved in advanced cysts with HGD or carcinoma.&#xD;
      The ongoing ZYSTEUS-study tries to implement DNA mutation analysis by Next Generation&#xD;
      Sequencing in the diagnostic algorithm of pancreas cyst evaluation. The first aim is to&#xD;
      distinguish mucinous from non-mucinous cysts. The second aim is to define relevant tumour&#xD;
      suppressor gene mutations which are relevant to distinguish between LGD and HGD/carcinoma in&#xD;
      mucinous cysts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intraductal papillary mucinous neoplasm (IPMN) with low grade dysplasia (LGD) can progress to&#xD;
      high grade dysplasia (HGD) or invasive cancer. Main duct IPMN, mixed type IPMN or branch duct&#xD;
      IPMN with high risk stigmata are highly predictive for malignancy. Therefore, patients in&#xD;
      good general state should be considered for surgical resection. Guidelines like the&#xD;
      International Fukuoka Consensus Guidelines from 2017 or the European evidence-based&#xD;
      Guidelines on Pancreatic cyst neoplasms from 2018 provide detailed recommendations on the&#xD;
      management of IPMNs by focusing on clinical characteristics, image morphology, cytology and&#xD;
      laboratory parameters. However, these applied guidelines still lead to surgical overtreatment&#xD;
      of pancreas cysts based on the pathologic outcomes as neither HGD nor carcinoma is found in&#xD;
      up to 82.1 % of the resected cysts. Cyst fluid sent for cytology usually provides adequate&#xD;
      cellular material for analysis in only 31% of the cases and Endoscopic Ultrasound-guided&#xD;
      forceps biopsy has not yet shown to be better than fine needle aspiration. Hence, further&#xD;
      diagnostic tools are needed to identify mucinous cysts for further evaluation or follow-up&#xD;
      respectively to identify cysts with HGD or invasive cancer at an early stage for surgical&#xD;
      resection. Molecular genetic analysis of pancreatic cyst fluid is possibly able to identify&#xD;
      KRAS/GNAS oncogenic driver mutations in mucinous cysts and to identify tumour suppressor gene&#xD;
      mutations which are involved in advanced cysts with HGD or carcinoma. This workgroup&#xD;
      described a high sensitive method of targeted Next Generation Sequencing in pancreas cyst&#xD;
      fluid with a limit of detection of allele frequency down to 0.01 %. Further investigations of&#xD;
      the ongoing ZYSTEUS-study are focused on the implementation of DNA mutation analysis by NGS&#xD;
      in the diagnostic algorithm of pancreas cyst evaluation. The first aim is to reliably&#xD;
      distinguish mucinous from non-mucinous cysts respectively main duct IPMN from chronic&#xD;
      pancreatitis with main duct dilatation as the absence of KRAS/GNAS-mutations is highly&#xD;
      predictive for non-mucinous diseases. The second aim is to define relevant tumour suppressor&#xD;
      gene mutations which are relevant to differentiate LGD from HGD/carcinoma in mucinous cysts.&#xD;
      DNA mutation analysis will be compared with already established peroperative diagnostic tests&#xD;
      of pancreas cyst fluid: Measurement of CEA and lipase as well as cytology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 2022</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>
    <intervention_model_description>DNA-mutation analysis by Next Generation Sequencing is performed to identify IPMN pancreas cysts with LGD versus HGD/Carcinoma.&#xD;
Controls: non-neoplastic pancreas cysts and chronic pancreatitis with main duct dilation</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients with a mucinous pancreas cyst</measure>
    <time_frame>From EUS-guided fine needle aspiration of pancreas cyst fluid up to seven days</time_frame>
    <description>Number of patients with the preoperative diagnosis of a mucinous pancreas cyst (numerator) in correlation with the number of patients with a mucinous pancreas cyst confirmed by surgery (denominator)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pancreas cyst with HGD or carcinoma</measure>
    <time_frame>From EUS-guided fine needle aspiration of pancreas cyst fluid up to seven days</time_frame>
    <description>Number of patients with the preoperative diagnosis of a HGD/carcinoma pancreas cyst (numerator) in correlation with the number of patients with a HGD/carcinoma pancreas cyst confirmed by surgery (denominator)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Pancreas Cyst</condition>
  <arm_group>
    <arm_group_label>Suspected mucinous pancreas cyst</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In all pancreas cysts &gt; 15mm and/or pancreas duct dilatation &gt; 5mm in patients who are fit for surgery EUS-guided pancreas cyst fluid aspiration is conducted. In cyst fluid CEA and lipase examination, cytology and Next Generation Sequencing is performed. After that, the pancreas cyst will be resected and histopathologically analysed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Next Generation Sequencing</intervention_name>
    <description>DNA Mutational Analysis in pancreas cyst fluid concerning KRAS/GNAS-mutations and mutations in tumor supressor genes</description>
    <arm_group_label>Suspected mucinous pancreas cyst</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CEA and lipase</intervention_name>
    <description>Measuring CEA and lipase level in pancreas cyst fluid:&#xD;
CEA &gt; 192 ng/ml and lipase &gt; 200 U/l = mucinous cyst</description>
    <arm_group_label>Suspected mucinous pancreas cyst</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cytology</intervention_name>
    <description>Cytology in pancreas cyst fluid:&#xD;
mucinous versus non-mucinous cyst; LGD versus HGD/Carcinoma</description>
    <arm_group_label>Suspected mucinous pancreas cyst</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Histology of resected pancreas cyst</intervention_name>
    <description>Histology of resected pancreas cyst concerning mucinous versus non-mucinous cyst, IPMN versus non-IPMN and LGD versus HGD/Carcinoma</description>
    <arm_group_label>Suspected mucinous pancreas cyst</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pancreas cysts with cyst size &gt; 15mm&#xD;
&#xD;
          -  pancreas with main duct dilation &gt; 5mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who are not fit for surgery&#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>Christel Weiß, Prof.Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>University of Heidelberg, Department of Medical Statistis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic</name>
      <address>
        <city>Mannheim</city>
        <zip>68165</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Felsenstein M, Noe M, Masica DL, Hosoda W, Chianchiano P, Fischer CG, Lionheart G, Brosens LAA, Pea A, Yu J, Gemenetzis G, Groot VP, Makary MA, He J, Weiss MJ, Cameron JL, Wolfgang CL, Hruban RH, Roberts NJ, Karchin R, Goggins MG, Wood LD. IPMNs with co-occurring invasive cancers: neighbours but not always relatives. Gut. 2018 Sep;67(9):1652-1662. doi: 10.1136/gutjnl-2017-315062. Epub 2018 Mar 2.</citation>
    <PMID>29500184</PMID>
  </reference>
  <reference>
    <citation>Kanda M, Sadakari Y, Borges M, Topazian M, Farrell J, Syngal S, Lee J, Kamel I, Lennon AM, Knight S, Fujiwara S, Hruban RH, Canto MI, Goggins M. Mutant TP53 in duodenal samples of pancreatic juice from patients with pancreatic cancer or high-grade dysplasia. Clin Gastroenterol Hepatol. 2013 Jun;11(6):719-30.e5. doi: 10.1016/j.cgh.2012.11.016. Epub 2012 Nov 28.</citation>
    <PMID>23200980</PMID>
  </reference>
  <reference>
    <citation>Singhi AD, McGrath K, Brand RE, Khalid A, Zeh HJ, Chennat JS, Fasanella KE, Papachristou GI, Slivka A, Bartlett DL, Dasyam AK, Hogg M, Lee KK, Marsh JW, Monaco SE, Ohori NP, Pingpank JF, Tsung A, Zureikat AH, Wald AI, Nikiforova MN. Preoperative next-generation sequencing of pancreatic cyst fluid is highly accurate in cyst classification and detection of advanced neoplasia. Gut. 2018 Dec;67(12):2131-2141. doi: 10.1136/gutjnl-2016-313586. Epub 2017 Sep 28.</citation>
    <PMID>28970292</PMID>
  </reference>
  <reference>
    <citation>Rosenbaum MW, Jones M, Dudley JC, Le LP, Iafrate AJ, Pitman MB. Next-generation sequencing adds value to the preoperative diagnosis of pancreatic cysts. Cancer Cytopathol. 2017 Jan;125(1):41-47. doi: 10.1002/cncy.21775. Epub 2016 Sep 20.</citation>
    <PMID>27647802</PMID>
  </reference>
  <reference>
    <citation>Amato E, Molin MD, Mafficini A, Yu J, Malleo G, Rusev B, Fassan M, Antonello D, Sadakari Y, Castelli P, Zamboni G, Maitra A, Salvia R, Hruban RH, Bassi C, Capelli P, Lawlor RT, Goggins M, Scarpa A. Targeted next-generation sequencing of cancer genes dissects the molecular profiles of intraductal papillary neoplasms of the pancreas. J Pathol. 2014 Jul;233(3):217-27. doi: 10.1002/path.4344.</citation>
    <PMID>24604757</PMID>
  </reference>
  <reference>
    <citation>Volckmar AL, Endris V, Gaida MM, Leichsenring J, Stogbauer F, Allgauer M, von Winterfeld M, Penzel R, Kirchner M, Brandt R, Neumann O, Sultmann H, Schirmacher P, Rudi J, Schmitz D, Stenzinger A. Next generation sequencing of the cellular and liquid fraction of pancreatic cyst fluid supports discrimination of IPMN from pseudocysts and reveals cases with multiple mutated driver clones: First findings from the prospective ZYSTEUS biomarker study. Genes Chromosomes Cancer. 2019 Jan;58(1):3-11. doi: 10.1002/gcc.22682. Epub 2018 Oct 17.</citation>
    <PMID>30230086</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>December 17, 2022</last_update_submitted>
  <last_update_submitted_qc>December 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DNA Mutational Analysis</keyword>
  <keyword>Cyst Fluid</keyword>
  <keyword>Pancreas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysts</mesh_term>
    <mesh_term>Pancreatic Cyst</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancrelipase</mesh_term>
  </intervention_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/NCT03820531
org study id: ZYSTEUS-Study
nct id: NCT03820531
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diagnostic tools are needed to identify mucinous cysts for further evaluation or follow-up
      respectively to identify cysts with HGD or invasive cancer at an early stage for surgical
      resection. Molecular genetic analysis of pancreatic cyst fluid is a new but rapidly evolving
      method to identify KRAS/GNAS oncogenic driver mutations in mucinous cysts and to identify
      tumour suppressor gene mutations which are involved in advanced cysts with HGD or carcinoma.
      The ongoing ZYSTEUS-study tries to implement DNA mutation analysis by Next Generation
      Sequencing in the diagnostic algorithm of pancreas cyst evaluation. The first aim is to
      distinguish mucinous from non-mucinous cysts. The second aim is to define relevant tumour
      suppressor gene mutations which are relevant to distinguish between LGD and HGD/carcinoma in
      mucinous cysts.
Intraductal papillary mucinous neoplasm (IPMN) with low grade dysplasia (LGD) can progress to
      high grade dysplasia (HGD) or invasive cancer. Main duct IPMN, mixed type IPMN or branch duct
      IPMN with high risk stigmata are highly predictive for malignancy. Therefore, patients in
      good general state should be considered for surgical resection. Guidelines like the
      International Fukuoka Consensus Guidelines from 2017 or the European evidence-based
      Guidelines on Pancreatic cyst neoplasms from 2018 provide detailed recommendations on the
      management of IPMNs by focusing on clinical characteristics, image morphology, cytology and
      laboratory parameters. However, these applied guidelines still lead to surgical overtreatment
      of pancreas cysts based on the pathologic outcomes as neither HGD nor carcinoma is found in
      up to 82.1 % of the resected cysts. Cyst fluid sent for cytology usually provides adequate
      cellular material for analysis in only 31% of the cases and Endoscopic Ultrasound-guided
      forceps biopsy has not yet shown to be better than fine needle aspiration. Hence, further
      diagnostic tools are needed to identify mucinous cysts for further evaluation or follow-up
      respectively to identify cysts with HGD or invasive cancer at an early stage for surgical
      resection. Molecular genetic analysis of pancreatic cyst fluid is possibly able to identify
      KRAS/GNAS oncogenic driver mutations in mucinous cysts and to identify tumour suppressor gene
      mutations which are involved in advanced cysts with HGD or carcinoma. This workgroup
      described a high sensitive method of targeted Next Generation Sequencing in pancreas cyst
      fluid with a limit of detection of allele frequency down to 0.01 %. Further investigations of
      the ongoing ZYSTEUS-study are focused on the implementation of DNA mutation analysis by NGS
      in the diagnostic algorithm of pancreas cyst evaluation. The first aim is to reliably
      distinguish mucinous from non-mucinous cysts respectively main duct IPMN from chronic
      pancreatitis with main duct dilatation as the absence of KRAS/GNAS-mutations is highly
      predictive for non-mucinous diseases. The second aim is to define relevant tumour suppressor
      gene mutations which are relevant to differentiate LGD from HGD/carcinoma in mucinous cysts.
      DNA mutation analysis will be compared with already established peroperative diagnostic tests
      of pancreas cyst fluid: Measurement of CEA and lipase as well as cytology.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: DNA-mutation analysis by Next Generation Sequencing is performed to identify IPMN pancreas cysts with LGD versus HGD/Carcinoma.
Controls: non-neoplastic pancreas cysts and chronic pancreatitis with main duct dilation
primary purpose: Diagnostic
masking: None (Open Label)
measure: Patients with a mucinous pancreas cyst
time frame: From EUS-guided fine needle aspiration of pancreas cyst fluid up to seven days
description: Number of patients with the preoperative diagnosis of a mucinous pancreas cyst (numerator) in correlation with the number of patients with a mucinous pancreas cyst confirmed by surgery (denominator)
measure: Pancreas cyst with HGD or carcinoma
time frame: From EUS-guided fine needle aspiration of pancreas cyst fluid up to seven days
description: Number of patients with the preoperative diagnosis of a HGD/carcinoma pancreas cyst (numerator) in correlation with the number of patients with a HGD/carcinoma pancreas cyst confirmed by surgery (denominator)
arm group label: Suspected mucinous pancreas cyst
arm group type: Experimental
description: In all pancreas cysts > 15mm and/or pancreas duct dilatation > 5mm in patients who are fit for surgery EUS-guided pancreas cyst fluid aspiration is conducted. In cyst fluid CEA and lipase examination, cytology and Next Generation Sequencing is performed. After that, the pancreas cyst will be resected and histopathologically analysed.
intervention type: Diagnostic Test
intervention name: Next Generation Sequencing
description: DNA Mutational Analysis in pancreas cyst fluid concerning KRAS/GNAS-mutations and mutations in tumor supressor genes
arm group label: Suspected mucinous pancreas cyst
intervention type: Diagnostic Test
intervention name: CEA and lipase
description: Measuring CEA and lipase level in pancreas cyst fluid:
CEA > 192 ng/ml and lipase > 200 U/l = mucinous cyst
arm group label: Suspected mucinous pancreas cyst
intervention type: Diagnostic Test
intervention name: Cytology
description: Cytology in pancreas cyst fluid:
mucinous versus non-mucinous cyst; LGD versus HGD/Carcinoma
arm group label: Suspected mucinous pancreas cyst
intervention type: Diagnostic Test
intervention name: Histology of resected pancreas cyst
description: Histology of resected pancreas cyst concerning mucinous versus non-mucinous cyst, IPMN versus non-IPMN and LGD versus HGD/Carcinoma
arm group label: Suspected mucinous pancreas cyst
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christel Weiß, Prof.Dr.
role: Study Chair
affiliation: University of Heidelberg, Department of Medical Statistis
facility: 
country: Germany
citation: Felsenstein M, Noe M, Masica DL, Hosoda W, Chianchiano P, Fischer CG, Lionheart G, Brosens LAA, Pea A, Yu J, Gemenetzis G, Groot VP, Makary MA, He J, Weiss MJ, Cameron JL, Wolfgang CL, Hruban RH, Roberts NJ, Karchin R, Goggins MG, Wood LD. IPMNs with co-occurring invasive cancers: neighbours but not always relatives. Gut. 2018 Sep;67(9):1652-1662. doi: 10.1136/gutjnl-2017-315062. Epub 2018 Mar 2.
PMID: 29500184
citation: Kanda M, Sadakari Y, Borges M, Topazian M, Farrell J, Syngal S, Lee J, Kamel I, Lennon AM, Knight S, Fujiwara S, Hruban RH, Canto MI, Goggins M. Mutant TP53 in duodenal samples of pancreatic juice from patients with pancreatic cancer or high-grade dysplasia. Clin Gastroenterol Hepatol. 2013 Jun;11(6):719-30.e5. doi: 10.1016/j.cgh.2012.11.016. Epub 2012 Nov 28.
PMID: 23200980
citation: Singhi AD, McGrath K, Brand RE, Khalid A, Zeh HJ, Chennat JS, Fasanella KE, Papachristou GI, Slivka A, Bartlett DL, Dasyam AK, Hogg M, Lee KK, Marsh JW, Monaco SE, Ohori NP, Pingpank JF, Tsung A, Zureikat AH, Wald AI, Nikiforova MN. Preoperative next-generation sequencing of pancreatic cyst fluid is highly accurate in cyst classification and detection of advanced neoplasia. Gut. 2018 Dec;67(12):2131-2141. doi: 10.1136/gutjnl-2016-313586. Epub 2017 Sep 28.
PMID: 28970292
citation: Rosenbaum MW, Jones M, Dudley JC, Le LP, Iafrate AJ, Pitman MB. Next-generation sequencing adds value to the preoperative diagnosis of pancreatic cysts. Cancer Cytopathol. 2017 Jan;125(1):41-47. doi: 10.1002/cncy.21775. Epub 2016 Sep 20.
PMID: 27647802
citation: Amato E, Molin MD, Mafficini A, Yu J, Malleo G, Rusev B, Fassan M, Antonello D, Sadakari Y, Castelli P, Zamboni G, Maitra A, Salvia R, Hruban RH, Bassi C, Capelli P, Lawlor RT, Goggins M, Scarpa A. Targeted next-generation sequencing of cancer genes dissects the molecular profiles of intraductal papillary neoplasms of the pancreas. J Pathol. 2014 Jul;233(3):217-27. doi: 10.1002/path.4344.
PMID: 24604757
citation: Volckmar AL, Endris V, Gaida MM, Leichsenring J, Stogbauer F, Allgauer M, von Winterfeld M, Penzel R, Kirchner M, Brandt R, Neumann O, Sultmann H, Schirmacher P, Rudi J, Schmitz D, Stenzinger A. Next generation sequencing of the cellular and liquid fraction of pancreatic cyst fluid supports discrimination of IPMN from pseudocysts and reveals cases with multiple mutated driver clones: First findings from the prospective ZYSTEUS biomarker study. Genes Chromosomes Cancer. 2019 Jan;58(1):3-11. doi: 10.1002/gcc.22682. Epub 2018 Oct 17.
PMID: 30230086
responsible party type: Sponsor
mesh term: Cysts
mesh term: Pancreatic Cyst
mesh term: Pancreatic Neoplasms
mesh term: Pancrelipase
sharing ipd: No