<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/NCT03795584</url>
  </required_header>
  <id_info>
    <org_study_id>HYH20180520</org_study_id>
    <nct_id>NCT03795584</nct_id>
  </id_info>
  <brief_title>Endoclip Papillaplasty Restores Sphincter of Oddi Function</brief_title>
  <official_title>Endoclip Papillaplasty Restores Sphincter of Oddi Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications&#xD;
      such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile&#xD;
      duct gallstones. Despite its efficacy and improvements over time, EST is still associated&#xD;
      with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of&#xD;
      function of the sphincter of Oddi (SO). Permanent loss of SO function can cause&#xD;
      duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence,&#xD;
      cholangitis, and liver abscess.&#xD;
&#xD;
      Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now&#xD;
      recognized as an alternative technique for the removal of CBD gallstones. The small balloon&#xD;
      (diameter &lt;8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves&#xD;
      the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter.&#xD;
      EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for&#xD;
      patients with large gallstone, but EPLBD widens the distal common bile duct and still may&#xD;
      cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may&#xD;
      reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no&#xD;
      efficient strategy has been proposed. The present pilot study aimed to examine the&#xD;
      feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair&#xD;
      the damaged ampulla and recover SO function. The advantage of this device is that it can be&#xD;
      rotated clockwise or counterclockwise by turning the handle until the correct position is&#xD;
      achieved. Another advantage is if the clip is not in desired position, it may be re-opened&#xD;
      and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly&#xD;
      attached to the tissue by pulling the slider back until tactile resistance is felt in the&#xD;
      handle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications&#xD;
      such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile&#xD;
      duct gallstones. Despite its efficacy and improvements over time, EST is still associated&#xD;
      with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of&#xD;
      function of the sphincter of Oddi (SO). Permanent loss of SO function can cause&#xD;
      duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence,&#xD;
      cholangitis, and liver abscess.&#xD;
&#xD;
      Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now&#xD;
      recognized as an alternative technique for the removal of CBD gallstones. The small balloon&#xD;
      (diameter &lt;8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves&#xD;
      the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter.&#xD;
      EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for&#xD;
      patients with large gallstone, but EPLBD widens the distal common bile duct and still may&#xD;
      cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may&#xD;
      reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no&#xD;
      efficient strategy has been proposed. The present pilot study aimed to examine the&#xD;
      feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair&#xD;
      the damaged ampulla and recover SO function. The advantage of this device is that it can be&#xD;
      rotated clockwise or counterclockwise by turning the handle until the correct position is&#xD;
      achieved. Another advantage is if the clip is not in desired position, it may be re-opened&#xD;
      and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly&#xD;
      attached to the tissue by pulling the slider back until tactile resistance is felt in the&#xD;
      handle.&#xD;
&#xD;
      The investigators will recruit patients according to admission criteria and exclusion&#xD;
      criteria. The participants underwent SOM before, immediately after EST, and 3 weeks after EST&#xD;
      with endoclip papilloplasty. The participants were followed for 3 days during hospitalized.&#xD;
      Complications including perforation, bleeding, and PEP were recorded. Blood routine,&#xD;
      pancreatic enzymes (amylase and lipase), and liver function (serum alanine aminotransferase,&#xD;
      aspartate aminotransferase, r-glutamyl transpeptidase, and alkaline phosphatase) were tested&#xD;
      at 4 and 24 h after ERCP. All participants were followed at 3 weeks. Symptoms were examined&#xD;
      and blood tests as above were repeated ahead of stents retrieval and sphincter of Oddi&#xD;
      monitoring through duodenoscope.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 21, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SO manometric data</measure>
    <time_frame>Before operation、During operation、Three weeks after operation</time_frame>
    <description>The comparison of the SO manometric data before and after the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of use of ML and the incidence of adverse events</measure>
    <time_frame>Three weeks after operation</time_frame>
    <description>Measure the frequency of use of ML and the incidence of adverse events, and to evaluate the healing of the ampulla.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Sphincter of Oddi Function</condition>
  <arm_group>
    <arm_group_label>Endoclip papillaplasty</arm_group_label>
    <description>Endoclip papilloplasty was performed to repair the Oddi sphincter using sterile repositionable hemostasis clipping device (Micro-tech (Nanjing), Co., Ltd.; stainless-steel). The participants underwent SOM before, immediately after EST, and 3 weeks after EST with endoclip papilloplasty. The participants were followed for 3 days during hospitalized.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sterile repositionable hemostasis clipping device close the large duodenal papilla incision</intervention_name>
    <description>After the bile duct stent was placed, the investigators can use sterile repositionable hemostasis clipping device to close large duodenal papilla incision at 11 o'clock on the duodenal papilla.</description>
    <arm_group_label>Endoclip papillaplasty</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This was a prospective pilot study of consecutive patients with CBD gallstones (transverse&#xD;
        diameter ≥10 mm) who were treated at the Gastroenterology Department of Peking University&#xD;
        Third Hospital by large-EST combined with endoclip papilloplasty between May 2018 and March&#xD;
        2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - 1)18-85 years of age; 2) informed consent obtained before ERCP; 3) CBD diameter ≥12 mm;&#xD;
        4) CBD gallstones visualized at magnetic resonance cholangiopancreatography (MRCP) with at&#xD;
        least one gallstone ≥10 mm (transverse diameter)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. gallstone transverse diameter &gt;35 mm, which is not appropriate to be extracted;&#xD;
&#xD;
          2. history of previous sphincterotomy, previous EPBD;&#xD;
&#xD;
          3. accompanied with choledochoduodenal fistula, coagulopathy, anticoagulant/antiplatelet&#xD;
             therapy, or Billroth II or Roux-en-Y reconstruction;&#xD;
&#xD;
          4. papilla located deep within a diverticulum;&#xD;
&#xD;
          5. small papilla and short intramural segment, which was not suitable for large EST;&#xD;
&#xD;
          6. medications known to affect the SO (calcium channel blockers, nitrates, opiates, and&#xD;
             anticholinergics) taken within 48 h of the procedure;&#xD;
&#xD;
          7. benign or malignant biliary stricture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yonghui Huang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University Third Hosptial</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yonghui Huang, MD</last_name>
    <phone>86-10-13911765322</phone>
    <email>13911765322@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Third Hosptial</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yonghui Huang, archiater</last_name>
      <phone>13911765322</phone>
      <email>pskyq@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Third Hospital</investigator_affiliation>
    <investigator_full_name>Huang Yonghui</investigator_full_name>
    <investigator_title>chief physician</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03795584
org study id: HYH20180520
nct id: NCT03795584
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications
      such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile
      duct gallstones. Despite its efficacy and improvements over time, EST is still associated
      with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of
      function of the sphincter of Oddi (SO). Permanent loss of SO function can cause
      duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence,
      cholangitis, and liver abscess.

      Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now
      recognized as an alternative technique for the removal of CBD gallstones. The small balloon
      (diameter <8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves
      the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter.
      EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for
      patients with large gallstone, but EPLBD widens the distal common bile duct and still may
      cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may
      reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no
      efficient strategy has been proposed. The present pilot study aimed to examine the
      feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair
      the damaged ampulla and recover SO function. The advantage of this device is that it can be
      rotated clockwise or counterclockwise by turning the handle until the correct position is
      achieved. Another advantage is if the clip is not in desired position, it may be re-opened
      and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly
      attached to the tissue by pulling the slider back until tactile resistance is felt in the
      handle.
Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications
      such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile
      duct gallstones. Despite its efficacy and improvements over time, EST is still associated
      with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of
      function of the sphincter of Oddi (SO). Permanent loss of SO function can cause
      duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence,
      cholangitis, and liver abscess.

      Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now
      recognized as an alternative technique for the removal of CBD gallstones. The small balloon
      (diameter <8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves
      the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter.
      EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for
      patients with large gallstone, but EPLBD widens the distal common bile duct and still may
      cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may
      reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no
      efficient strategy has been proposed. The present pilot study aimed to examine the
      feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair
      the damaged ampulla and recover SO function. The advantage of this device is that it can be
      rotated clockwise or counterclockwise by turning the handle until the correct position is
      achieved. Another advantage is if the clip is not in desired position, it may be re-opened
      and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly
      attached to the tissue by pulling the slider back until tactile resistance is felt in the
      handle.

      The investigators will recruit patients according to admission criteria and exclusion
      criteria. The participants underwent SOM before, immediately after EST, and 3 weeks after EST
      with endoclip papilloplasty. The participants were followed for 3 days during hospitalized.
      Complications including perforation, bleeding, and PEP were recorded. Blood routine,
      pancreatic enzymes (amylase and lipase), and liver function (serum alanine aminotransferase,
      aspartate aminotransferase, r-glutamyl transpeptidase, and alkaline phosphatase) were tested
      at 4 and 24 h after ERCP. All participants were followed at 3 weeks. Symptoms were examined
      and blood tests as above were repeated ahead of stents retrieval and sphincter of Oddi
      monitoring through duodenoscope.
observational model: Case-Only
time perspective: Prospective
measure: SO manometric data
time frame: Before operation、During operation、Three weeks after operation
description: The comparison of the SO manometric data before and after the procedure
measure: Frequency of use of ML and the incidence of adverse events
time frame: Three weeks after operation
description: Measure the frequency of use of ML and the incidence of adverse events, and to evaluate the healing of the ampulla.
arm group label: Endoclip papillaplasty
description: Endoclip papilloplasty was performed to repair the Oddi sphincter using sterile repositionable hemostasis clipping device (Micro-tech (Nanjing), Co., Ltd.; stainless-steel). The participants underwent SOM before, immediately after EST, and 3 weeks after EST with endoclip papilloplasty. The participants were followed for 3 days during hospitalized.
intervention type: Procedure
intervention name: sterile repositionable hemostasis clipping device close the large duodenal papilla incision
description: After the bile duct stent was placed, the investigators can use sterile repositionable hemostasis clipping device to close large duodenal papilla incision at 11 o'clock on the duodenal papilla.
arm group label: Endoclip papillaplasty
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yonghui Huang, MD
role: Study Director
affiliation: Peking University Third Hosptial
last name: Yonghui Huang, MD
phone: 86-10-13911765322
email: 13911765322@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Third Hospital
investigator full name: Huang Yonghui
investigator title: chief physician
mesh term: Hemostatics