<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/NCT04431427</url>
  </required_header>
  <id_info>
    <org_study_id>05.2020</org_study_id>
    <nct_id>NCT04431427</nct_id>
  </id_info>
  <brief_title>Partially Covered Metal Stents Efficacy in Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction</brief_title>
  <acronym>METARSI</acronym>
  <official_title>Partially Covered Metal Stents Efficacy in the Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction, a Multicentric Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Santi Mangiafico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliero-Universitaria di Modena</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malignant obstructions of the bile duct are not rare. The most common and accepted method for&#xD;
      biliary drainage is endoscopic stent placement. There are three types of metal stents: fully&#xD;
      covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced&#xD;
      and compared to FC-SEMS they seem to have a lower risk of migration, although data in the&#xD;
      literature are discordant. Therefore the investigators will randomize the participants with&#xD;
      biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS. After&#xD;
      metallic biliary stent insertion, enrolled patients will be followed for 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malignant obstructions of the bile duct are generally caused by: adenocarcinoma of the Vater&#xD;
      ampulla, pancreas head cancer, cholangiocarcinoma and external compression secondary to lymph&#xD;
      node (LN) metastasis. The management of jaundice and cholangitis, as a result of bile&#xD;
      stenosis, is crucial in this group of patients. The most common and accepted method for&#xD;
      biliary drainage is endoscopic stent placement with plastic stents or self-expandable metal&#xD;
      stents (SEMS). In recent times, the use of SEMS has become more common as it provides longer&#xD;
      times of patency and a reduced risk of adverse events such as cholangitic episodes. There are&#xD;
      three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U).&#xD;
      PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk&#xD;
      of migration, however different randomized and non-randomized studies have compared the&#xD;
      outcome of U-SEMS vs FC-SEMS with between uncovered and covered stents have produced&#xD;
      different results regarding the cumulative patency of stents and endoscopic re-intervention&#xD;
      rates. To date, there are few and discordant prospective data on the outcomes of PC-SEMS use&#xD;
      in malignant biliary obstructions.&#xD;
&#xD;
      Therefore, the investigators will randomize the participants with biliary obstruction in 2&#xD;
      groups according to the type of stent used: PC-SEMS or U-SEMS (T0 timing).&#xD;
&#xD;
      Then the participants will be followed for total period of 12 months. 2 different timings of&#xD;
      follow-up will be considered:&#xD;
&#xD;
      - T1: it will start after stent insertion. The biliary drainage will be considered effective,&#xD;
      according to the European guidelines, when the bilirubin values will be &lt; or = 2 mg/dl for a&#xD;
      period of at least 6 weeks if the initial bilirubin values were higher than 10 mg/dl or 3&#xD;
      weeks if at the beginning were lower than 10 mg/dl; After this first phase, all the enrolled&#xD;
      patients will be divided in 2 groups according to their &quot;fitness&quot; for chemiotherapy: FIT and&#xD;
      UNFIT Group.&#xD;
&#xD;
      FIT group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study&#xD;
      once every three months.&#xD;
&#xD;
      UNFIT Group: blood test (including total bilirubin, gamma-GT) will be done for follow-up&#xD;
      study after 3, 9 and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2021</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Re-intervention rate</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation in both arms of the re-intervention rate considered as any procedure needed for a new drainage of the biliary tree, endoscopic or percutaneous, to replace a dysfunctional stent.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of patency, migration and adverse events rate</measure>
    <time_frame>12 months</time_frame>
    <description>evaluation of patency, migration and adverse events rate for each arm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Biliary Obstruction</condition>
  <arm_group>
    <arm_group_label>Partially Covered Metal Stent Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study. Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent). After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Uncovered Metal Stent Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study. Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent). After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biliary drainage with PC-SEMS</intervention_name>
    <description>partially covered metallic biliary stent insertion during ERCP</description>
    <arm_group_label>Partially Covered Metal Stent Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biliary drainage with U-SEMS</intervention_name>
    <description>Uncovered metallic biliary stent insertion during ERCP</description>
    <arm_group_label>Uncovered Metal Stent Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        •The patients who had malignant biliary obstruction with a estimated survival &gt;4 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients who had resectable biliary malignancy&#xD;
&#xD;
          -  The patients who had hilar obstruction&#xD;
&#xD;
          -  The patients who had duodenal obstruction&#xD;
&#xD;
          -  The patients who had International Normalized Ratio (INR)&gt;1.5&#xD;
&#xD;
          -  The patients who did not give informed consent&#xD;
&#xD;
          -  The patients who had technically difficult structure for Endoscopic retrograde&#xD;
             cholangiopancreatography (ERCP)&#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_contact>
    <last_name>SILVIA COCCA, MD</last_name>
    <phone>00393756213301</phone>
    <email>cocca.silvia@aou.mo.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Santi Mangiafico, MD</last_name>
    <email>mangiafico.santi@aou.mo.it</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Bowlus CL, Olson KA, Gershwin ME. Evaluation of indeterminate biliary strictures. Nat Rev Gastroenterol Hepatol. 2016 Jan;13(1):28-37. doi: 10.1038/nrgastro.2015.182. Epub 2015 Nov 3. Erratum In: Nat Rev Gastroenterol Hepatol. 2017 Nov 02;:</citation>
    <PMID>26526122</PMID>
  </results_reference>
  <results_reference>
    <citation>Reisman Y, Gips CH, Lavelle SM, Wilson JH. Clinical presentation of (subclinical) jaundice--the Euricterus project in The Netherlands. United Dutch Hospitals and Euricterus Project Management Group. Hepatogastroenterology. 1996 Sep-Oct;43(11):1190-5.</citation>
    <PMID>8908550</PMID>
  </results_reference>
  <results_reference>
    <citation>Zorron Pu L, de Moura EG, Bernardo WM, Baracat FI, Mendonca EQ, Kondo A, Luz GO, Furuya Junior CK, Artifon EL. Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis. World J Gastroenterol. 2015 Dec 21;21(47):13374-85. doi: 10.3748/wjg.v21.i47.13374.</citation>
    <PMID>26715823</PMID>
  </results_reference>
  <results_reference>
    <citation>Dumonceau JM, Tringali A, Papanikolaou IS, Blero D, Mangiavillano B, Schmidt A, Vanbiervliet G, Costamagna G, Deviere J, Garcia-Cano J, Gyokeres T, Hassan C, Prat F, Siersema PD, van Hooft JE. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017. Endoscopy. 2018 Sep;50(9):910-930. doi: 10.1055/a-0659-9864. Epub 2018 Aug 7.</citation>
    <PMID>30086596</PMID>
  </results_reference>
  <results_reference>
    <citation>Crippa S, Cirocchi R, Partelli S, Petrone MC, Muffatti F, Renzi C, Falconi M, Arcidiacono PG. Systematic review and meta-analysis of metal versus plastic stents for preoperative biliary drainage in resectable periampullary or pancreatic head tumors. Eur J Surg Oncol. 2016 Sep;42(9):1278-85. doi: 10.1016/j.ejso.2016.05.001. Epub 2016 May 24.</citation>
    <PMID>27296728</PMID>
  </results_reference>
  <results_reference>
    <citation>Mukai T, Yasuda I, Nakashima M, Doi S, Iwashita T, Iwata K, Kato T, Tomita E, Moriwaki H. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2013 Feb;20(2):214-22. doi: 10.1007/s00534-012-0508-8.</citation>
    <PMID>22415652</PMID>
  </results_reference>
  <results_reference>
    <citation>Tsuboi T, Sasaki T, Serikawa M, Ishii Y, Mouri T, Shimizu A, Kurihara K, Tatsukawa Y, Miyaki E, Kawamura R, Tsushima K, Murakami Y, Uemura K, Chayama K. Preoperative Biliary Drainage in Cases of Borderline Resectable Pancreatic Cancer Treated with Neoadjuvant Chemotherapy and Surgery. Gastroenterol Res Pract. 2016;2016:7968201. doi: 10.1155/2016/7968201. Epub 2016 Jan 6.</citation>
    <PMID>26880897</PMID>
  </results_reference>
  <results_reference>
    <citation>Yang MJ, Kim JH, Yoo BM, Hwang JC, Yoo JH, Lee KS, Kang JK, Kim SS, Lim SG, Shin SJ, Cheong JY, Lee KM, Lee KJ, Cho SW. Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial. Scand J Gastroenterol. 2015;50(12):1490-9. doi: 10.3109/00365521.2015.1057219. Epub 2015 Jul 1.</citation>
    <PMID>26133200</PMID>
  </results_reference>
  <results_reference>
    <citation>Kitano M, Yamashita Y, Tanaka K, Konishi H, Yazumi S, Nakai Y, Nishiyama O, Uehara H, Mitoro A, Sanuki T, Takaoka M, Koshitani T, Arisaka Y, Shiba M, Hoki N, Sato H, Sasaki Y, Sato M, Hasegawa K, Kawabata H, Okabe Y, Mukai H. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol. 2013 Nov;108(11):1713-22. doi: 10.1038/ajg.2013.305. Epub 2013 Sep 17.</citation>
    <PMID>24042190</PMID>
  </results_reference>
  <results_reference>
    <citation>Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.</citation>
    <PMID>31863440</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero-Universitaria di Modena</investigator_affiliation>
    <investigator_full_name>Santi Mangiafico</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Malignant biliary obstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholestasis, Extrahepatic</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/NCT04431427
org study id: 05.2020
nct id: NCT04431427
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Malignant obstructions of the bile duct are not rare. The most common and accepted method for
      biliary drainage is endoscopic stent placement. There are three types of metal stents: fully
      covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced
      and compared to FC-SEMS they seem to have a lower risk of migration, although data in the
      literature are discordant. Therefore the investigators will randomize the participants with
      biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS. After
      metallic biliary stent insertion, enrolled patients will be followed for 12 months.
Malignant obstructions of the bile duct are generally caused by: adenocarcinoma of the Vater
      ampulla, pancreas head cancer, cholangiocarcinoma and external compression secondary to lymph
      node (LN) metastasis. The management of jaundice and cholangitis, as a result of bile
      stenosis, is crucial in this group of patients. The most common and accepted method for
      biliary drainage is endoscopic stent placement with plastic stents or self-expandable metal
      stents (SEMS). In recent times, the use of SEMS has become more common as it provides longer
      times of patency and a reduced risk of adverse events such as cholangitic episodes. There are
      three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U).
      PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk
      of migration, however different randomized and non-randomized studies have compared the
      outcome of U-SEMS vs FC-SEMS with between uncovered and covered stents have produced
      different results regarding the cumulative patency of stents and endoscopic re-intervention
      rates. To date, there are few and discordant prospective data on the outcomes of PC-SEMS use
      in malignant biliary obstructions.

      Therefore, the investigators will randomize the participants with biliary obstruction in 2
      groups according to the type of stent used: PC-SEMS or U-SEMS (T0 timing).

      Then the participants will be followed for total period of 12 months. 2 different timings of
      follow-up will be considered:

      - T1: it will start after stent insertion. The biliary drainage will be considered effective,
      according to the European guidelines, when the bilirubin values will be < or = 2 mg/dl for a
      period of at least 6 weeks if the initial bilirubin values were higher than 10 mg/dl or 3
      weeks if at the beginning were lower than 10 mg/dl; After this first phase, all the enrolled
      patients will be divided in 2 groups according to their "fitness" for chemiotherapy: FIT and
      UNFIT Group.

      FIT group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study
      once every three months.

      UNFIT Group: blood test (including total bilirubin, gamma-GT) will be done for follow-up
      study after 3, 9 and 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Re-intervention rate
time frame: 12 months
description: Evaluation in both arms of the re-intervention rate considered as any procedure needed for a new drainage of the biliary tree, endoscopic or percutaneous, to replace a dysfunctional stent.
measure: Evaluation of patency, migration and adverse events rate
time frame: 12 months
description: evaluation of patency, migration and adverse events rate for each arm
arm group label: Partially Covered Metal Stent Arm
arm group type: Active Comparator
description: The patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study. Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent). After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl.
arm group label: Uncovered Metal Stent Arm
arm group type: Active Comparator
description: The patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study. Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent). After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl.
intervention type: Device
intervention name: Biliary drainage with PC-SEMS
description: partially covered metallic biliary stent insertion during ERCP
arm group label: Partially Covered Metal Stent Arm
intervention type: Device
intervention name: Biliary drainage with U-SEMS
description: Uncovered metallic biliary stent insertion during ERCP
arm group label: Uncovered Metal Stent Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: SILVIA COCCA, MD
phone: 00393756213301
email: cocca.silvia@aou.mo.it
last name: Santi Mangiafico, MD
email: mangiafico.santi@aou.mo.it
citation: Bowlus CL, Olson KA, Gershwin ME. Evaluation of indeterminate biliary strictures. Nat Rev Gastroenterol Hepatol. 2016 Jan;13(1):28-37. doi: 10.1038/nrgastro.2015.182. Epub 2015 Nov 3. Erratum In: Nat Rev Gastroenterol Hepatol. 2017 Nov 02;:
PMID: 26526122
citation: Reisman Y, Gips CH, Lavelle SM, Wilson JH. Clinical presentation of (subclinical) jaundice--the Euricterus project in The Netherlands. United Dutch Hospitals and Euricterus Project Management Group. Hepatogastroenterology. 1996 Sep-Oct;43(11):1190-5.
PMID: 8908550
citation: Zorron Pu L, de Moura EG, Bernardo WM, Baracat FI, Mendonca EQ, Kondo A, Luz GO, Furuya Junior CK, Artifon EL. Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis. World J Gastroenterol. 2015 Dec 21;21(47):13374-85. doi: 10.3748/wjg.v21.i47.13374.
PMID: 26715823
citation: Dumonceau JM, Tringali A, Papanikolaou IS, Blero D, Mangiavillano B, Schmidt A, Vanbiervliet G, Costamagna G, Deviere J, Garcia-Cano J, Gyokeres T, Hassan C, Prat F, Siersema PD, van Hooft JE. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017. Endoscopy. 2018 Sep;50(9):910-930. doi: 10.1055/a-0659-9864. Epub 2018 Aug 7.
PMID: 30086596
citation: Crippa S, Cirocchi R, Partelli S, Petrone MC, Muffatti F, Renzi C, Falconi M, Arcidiacono PG. Systematic review and meta-analysis of metal versus plastic stents for preoperative biliary drainage in resectable periampullary or pancreatic head tumors. Eur J Surg Oncol. 2016 Sep;42(9):1278-85. doi: 10.1016/j.ejso.2016.05.001. Epub 2016 May 24.
PMID: 27296728
citation: Mukai T, Yasuda I, Nakashima M, Doi S, Iwashita T, Iwata K, Kato T, Tomita E, Moriwaki H. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2013 Feb;20(2):214-22. doi: 10.1007/s00534-012-0508-8.
PMID: 22415652
citation: Tsuboi T, Sasaki T, Serikawa M, Ishii Y, Mouri T, Shimizu A, Kurihara K, Tatsukawa Y, Miyaki E, Kawamura R, Tsushima K, Murakami Y, Uemura K, Chayama K. Preoperative Biliary Drainage in Cases of Borderline Resectable Pancreatic Cancer Treated with Neoadjuvant Chemotherapy and Surgery. Gastroenterol Res Pract. 2016;2016:7968201. doi: 10.1155/2016/7968201. Epub 2016 Jan 6.
PMID: 26880897
citation: Yang MJ, Kim JH, Yoo BM, Hwang JC, Yoo JH, Lee KS, Kang JK, Kim SS, Lim SG, Shin SJ, Cheong JY, Lee KM, Lee KJ, Cho SW. Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial. Scand J Gastroenterol. 2015;50(12):1490-9. doi: 10.3109/00365521.2015.1057219. Epub 2015 Jul 1.
PMID: 26133200
citation: Kitano M, Yamashita Y, Tanaka K, Konishi H, Yazumi S, Nakai Y, Nishiyama O, Uehara H, Mitoro A, Sanuki T, Takaoka M, Koshitani T, Arisaka Y, Shiba M, Hoki N, Sato H, Sasaki Y, Sato M, Hasegawa K, Kawabata H, Okabe Y, Mukai H. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol. 2013 Nov;108(11):1713-22. doi: 10.1038/ajg.2013.305. Epub 2013 Sep 17.
PMID: 24042190
citation: Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PMID: 31863440
responsible party type: Sponsor-Investigator
investigator affiliation: Azienda Ospedaliero-Universitaria di Modena
investigator full name: Santi Mangiafico
investigator title: Medical Doctor
mesh term: Cholestasis, Extrahepatic
sharing ipd: No