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/NCT06001476</url>
    </required_header>
    <id_info>
      <org_study_id>2023-SDU-QILU-G002</org_study_id>
      <nct_id>NCT06001476</nct_id>
    </id_info>
    <brief_title>Cold Snare Polypectomy for Small Bowel Polyps in Patients With Peutz-Jeghers Syndrome</brief_title>
    <official_title>Feasibility and Safety Analysis of Cold Snare Polypectomy in 5-9mm Small Intestinal Polyp Resection in Patients With Peutz-Jeghers Syndrome: A Prospective, Interventional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shandong University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to evaluate the feasibility and safety of Cold snare polypectomy for removing&#xD;
        5-9mm small intestinal polyps in patients with Peutz-Jeghers Syndrome (PJS),in order to&#xD;
        provide some reference for clinical strategy of endoscopic treatment of small intestinal&#xD;
        polyps in PJS patients, and may prolong the follow-up period of PJS patients Intervals.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>Phase 4</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 complications in the application of cold snare polypectomy for 5-9mm small bowel polypectomy in patients with PJS</measure>
      <time_frame>28 days after the procedure</time_frame>
      <description>The complications include complications during CSP and complications occurring within 28 days after enteroscopy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of complications during cold snare polypectomy for 5-9mm small bowel polypectomy</measure>
      <time_frame>Immediately after the procedure</time_frame>
      <description>Including intraoperative bleeding (defined as active haemorrhage for more than 30s), perforation immediately, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of complications within 28 days after enteroscopy</measure>
      <time_frame>28 days after the procedure</time_frame>
      <description>Including Delayed bleeding, delayed perforation, pancreatitis, electrocoagulation syndrome.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Peutz-Jeghers Syndrome</condition>
    <condition>Small Bowel Polyp</condition>
    <arm_group>
      <arm_group_label>Cold snare polypectomy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Cold snare polypectomy</intervention_name>
      <description>For eligible patients, use cold snare polypectomy to resect 5-9mm short-pedicled, broad-pedicled or sessile small bowel polyps</description>
      <arm_group_label>Cold snare polypectomy group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 8-60, male or female.&#xD;
  &#xD;
            -  Diagnosed with Peutz-Jeghers Syndrome&#xD;
  &#xD;
            -  Undergo enteroscopy for small bowel polypectomy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Absence of at least one study polyp (5-9mm stubby pedicle, wide pedicle and sessile&#xD;
               small bowel polyps);&#xD;
  &#xD;
            -  Be evaluated during enteroscopy for requiring surgical intervention (such as&#xD;
               endoscopically difficult to handle giant polyps, intussusception, etc.)；&#xD;
  &#xD;
            -  With more than 50 polyps ≥1cm found in this enteroscopy examination;&#xD;
  &#xD;
            -  The polyp has been confirmed to be malignant by pathology, or highly suspicious of&#xD;
               malignant transformation under endoscopy;&#xD;
  &#xD;
            -  Receiving anticoagulant therapy during this treatment;&#xD;
  &#xD;
            -  Unable or unwilling to provide informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Qilu Hospital, Shandong University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250012</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>van Leerdam ME, Roos VH, van Hooft JE, Dekker E, Jover R, Kaminski MF, Latchford A, Neumann H, Pellise M, Saurin JC, Tanis PJ, Wagner A, Balaguer F, Ricciardiello L. Endoscopic management of polyposis syndromes: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2019 Sep;51(9):877-895. doi: 10.1055/a-0965-0605. Epub 2019 Jul 23.</citation>
      <PMID>31342472</PMID>
    </reference>
    <reference>
      <citation>Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.</citation>
      <PMID>28212588</PMID>
    </reference>
    <reference>
      <citation>Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28.</citation>
      <PMID>28970290</PMID>
    </reference>
    <reference>
      <citation>Sakamoto H, Yamamoto H, Hayashi Y, Yano T, Miyata T, Nishimura N, Shinhata H, Sato H, Sunada K, Sugano K. Nonsurgical management of small-bowel polyps in Peutz-Jeghers syndrome with extensive polypectomy by using double-balloon endoscopy. Gastrointest Endosc. 2011 Aug;74(2):328-33. doi: 10.1016/j.gie.2011.04.001. Epub 2011 Jun 25.</citation>
      <PMID>21704992</PMID>
    </reference>
    <reference>
      <citation>Wang YX, Bian J, Zhu HY, Dong YH, Fang AQ, Li ZS, Du YQ. The role of double-balloon enteroscopy in reducing the maximum size of polyps in patients with Peutz-Jeghers syndrome: 12-year experience. J Dig Dis. 2019 Aug;20(8):415-420. doi: 10.1111/1751-2980.12784. Epub 2019 Jun 17.</citation>
      <PMID>31099986</PMID>
    </reference>
    <reference>
      <citation>Sato J, Hirooka Y, Watanabe O, Nakamura M, Yamamura T, Funasaka K, Ohno E, Kawashima H, Miyahara R, Goto H. Newly Developed Endoscopic Treatment for Small Bowel Polyps: Cold Snare Polypectomy. Intern Med. 2016;55(18):2601-3. doi: 10.2169/internalmedicine.55.6732. Epub 2016 Sep 15.</citation>
      <PMID>27629953</PMID>
    </reference>
    <reference>
      <citation>Hamada K, Takeuchi Y, Ishikawa H, Tonai Y, Matsuura N, Ezoe Y, Ishihara R, Tomita Y, Iishi H. Feasibility of Cold Snare Polypectomy for Multiple Duodenal Adenomas in Patients with Familial Adenomatous Polyposis: A Pilot Study. Dig Dis Sci. 2016 Sep;61(9):2755-9. doi: 10.1007/s10620-016-4165-7. Epub 2016 Apr 28. No abstract available.</citation>
      <PMID>27126203</PMID>
    </reference>
    <reference>
      <citation>Maruoka D, Matsumura T, Kasamatsu S, Ishigami H, Taida T, Okimoto K, Nakagawa T, Katsuno T, Arai M. Cold polypectomy for duodenal adenomas: a prospective clinical trial. Endoscopy. 2017 Aug;49(8):776-783. doi: 10.1055/s-0043-107028. Epub 2017 May 10.</citation>
      <PMID>28493238</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shandong University</investigator_affiliation>
      <investigator_full_name>Xiuli Zuo</investigator_full_name>
      <investigator_title>Director of Qilu Hospital gastroenterology department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peutz-Jeghers Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Polyps</mesh_term>
      <mesh_term>Intestinal Polyps</mesh_term>
    </condition_browse>
    <!-- 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/NCT06001476
  org study id: 2023-SDU-QILU-G002
  nct id: NCT06001476
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate the feasibility and safety of Cold snare polypectomy for removing
        5-9mm small intestinal polyps in patients with Peutz-Jeghers Syndrome (PJS),in order to
        provide some reference for clinical strategy of endoscopic treatment of small intestinal
        polyps in PJS patients, and may prolong the follow-up period of PJS patients Intervals.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of complications in the application of cold snare polypectomy for 5-9mm small bowel polypectomy in patients with PJS
  time frame: 28 days after the procedure
  description: The complications include complications during CSP and complications occurring within 28 days after enteroscopy
  measure: Incidence of complications during cold snare polypectomy for 5-9mm small bowel polypectomy
  time frame: Immediately after the procedure
  description: Including intraoperative bleeding (defined as active haemorrhage for more than 30s), perforation immediately, etc.
  measure: Incidence of complications within 28 days after enteroscopy
  time frame: 28 days after the procedure
  description: Including Delayed bleeding, delayed perforation, pancreatitis, electrocoagulation syndrome.
  arm group label: Cold snare polypectomy group
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Cold snare polypectomy
  description: For eligible patients, use cold snare polypectomy to resect 5-9mm short-pedicled, broad-pedicled or sessile small bowel polyps
  arm group label: Cold snare polypectomy group
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 60 Years
  healthy volunteers: No
  facility: 
  country: China
  citation: van Leerdam ME, Roos VH, van Hooft JE, Dekker E, Jover R, Kaminski MF, Latchford A, Neumann H, Pellise M, Saurin JC, Tanis PJ, Wagner A, Balaguer F, Ricciardiello L. Endoscopic management of polyposis syndromes: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2019 Sep;51(9):877-895. doi: 10.1055/a-0965-0605. Epub 2019 Jul 23.
  PMID: 31342472
  citation: Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
  PMID: 28212588
  citation: Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28.
  PMID: 28970290
  citation: Sakamoto H, Yamamoto H, Hayashi Y, Yano T, Miyata T, Nishimura N, Shinhata H, Sato H, Sunada K, Sugano K. Nonsurgical management of small-bowel polyps in Peutz-Jeghers syndrome with extensive polypectomy by using double-balloon endoscopy. Gastrointest Endosc. 2011 Aug;74(2):328-33. doi: 10.1016/j.gie.2011.04.001. Epub 2011 Jun 25.
  PMID: 21704992
  citation: Wang YX, Bian J, Zhu HY, Dong YH, Fang AQ, Li ZS, Du YQ. The role of double-balloon enteroscopy in reducing the maximum size of polyps in patients with Peutz-Jeghers syndrome: 12-year experience. J Dig Dis. 2019 Aug;20(8):415-420. doi: 10.1111/1751-2980.12784. Epub 2019 Jun 17.
  PMID: 31099986
  citation: Sato J, Hirooka Y, Watanabe O, Nakamura M, Yamamura T, Funasaka K, Ohno E, Kawashima H, Miyahara R, Goto H. Newly Developed Endoscopic Treatment for Small Bowel Polyps: Cold Snare Polypectomy. Intern Med. 2016;55(18):2601-3. doi: 10.2169/internalmedicine.55.6732. Epub 2016 Sep 15.
  PMID: 27629953
  citation: Hamada K, Takeuchi Y, Ishikawa H, Tonai Y, Matsuura N, Ezoe Y, Ishihara R, Tomita Y, Iishi H. Feasibility of Cold Snare Polypectomy for Multiple Duodenal Adenomas in Patients with Familial Adenomatous Polyposis: A Pilot Study. Dig Dis Sci. 2016 Sep;61(9):2755-9. doi: 10.1007/s10620-016-4165-7. Epub 2016 Apr 28. No abstract available.
  PMID: 27126203
  citation: Maruoka D, Matsumura T, Kasamatsu S, Ishigami H, Taida T, Okimoto K, Nakagawa T, Katsuno T, Arai M. Cold polypectomy for duodenal adenomas: a prospective clinical trial. Endoscopy. 2017 Aug;49(8):776-783. doi: 10.1055/s-0043-107028. Epub 2017 May 10.
  PMID: 28493238
  responsible party type: Principal Investigator
  investigator affiliation: Shandong University
  investigator full name: Xiuli Zuo
  investigator title: Director of Qilu Hospital gastroenterology department
  mesh term: Peutz-Jeghers Syndrome
  mesh term: Syndrome
  mesh term: Polyps
  mesh term: Intestinal Polyps