<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/NCT04406961</url>
  </required_header>
  <id_info>
    <org_study_id>0682539685</org_study_id>
    <nct_id>NCT04406961</nct_id>
  </id_info>
  <brief_title>Endoscopic Transpapillary Interventions.</brief_title>
  <official_title>Endoscopic Transpapillary Antegrade Sphincterotomy Developed by Dr. Dovbenko.(ASD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Military Medical Clinical Center of the Southern Region, Ukraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Military Medical Clinical Center of the Southern Region, Ukraine</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>
      The aim of the research has become to create a sphincterotome and a method that takes into&#xD;
      account the anatomical structure of the sph Oddi. The disadvantages of pull-type&#xD;
      sphincterotome led to develop a new sphincterotome. The characteristic features of new&#xD;
      antegrade sphincterotome are: it is inserted ready to use; the direction of cutting is&#xD;
      strictly determined; fully controlled depth of the cut. Thanks to shaping as it hook the&#xD;
      sphincterotome has been extracted cutting the circular layer only. The cutting wire is&#xD;
      located between two teflon catheters preventing the longitudinal muscle layer from being&#xD;
      damaged. The distance between the catheters determines the depth of the cut. Endoscopic&#xD;
      transpapillary antegrade sphincterotomy developed by Dr. Dovbenko -(ASD) performance in such&#xD;
      case allowed: to manage the papillary stenosis; to treat complicated form of gallstone&#xD;
      disease; In research group this method allowed to avoid cholecystectomy in 71,2 % of cases&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sph of Oddi consists of a circular inner muscle layer and a longitudinal outer muscle layer.&#xD;
      The circular layer does not depend on the duodenum. The longitudinal layer passes from the&#xD;
      wall of the duodenum and separates ascending and descending parts superimposing over its&#xD;
      circular layer. The arrangement of these layers towards each others is constant. Mostly ERCP&#xD;
      complications are caused by the interventions in major papilla and remain at a high level of&#xD;
      frequency up to 23 % Cutting all the layers of duodenum leads to bleeding up to 3 %. The&#xD;
      perforation might happened up to 1 % Destruction of the opening mechanism after&#xD;
      sphincterotomy leads to develop of reflux cholangitis, acute cholecystitis. It is possible to&#xD;
      avoid further cholecystectomy only in 10% of patients. Incapability of performing the&#xD;
      retrograde sphincterotomy in patients with extended papillary stenosis led to the creation of&#xD;
      a new method - ASD. Retrograde and antegrade sphincterotomies are analysed. 750 patients&#xD;
      underwent ASD within 7 years 65 % in urgent cases . Relative risk of complication after ASD&#xD;
      performing 3 times less. Taking into consideration possible post-ASD inner edema, plastic&#xD;
      biliary/pancreatic stent(s) are required during 5-10 days after. Standard methods for post&#xD;
      ERCP pancreatitis prevention must be applied in all cases. The new method performed some&#xD;
      selective. First of all young patient with alone stone in the common bile duct, women after&#xD;
      after childbirth. secondly, elderly patient were cured by ASD. And as well as a group of&#xD;
      patients with severe comorbid diseases, such as renal failure, acute myocardial infarction.&#xD;
      In our research, in two patients with AIDS was performed ASD. They were on special treatment&#xD;
      after being diagnosed with HIV-infection, within 2 years. It was SSC. Papillary stenosis and&#xD;
      cholangiolithiasis were cured successfully. The use of ASD with preservation of the closure&#xD;
      function of the sph. Oddi allowed to avoid cholecystectomy in 71.2%. ASD can be performed new&#xD;
      design of sphincterotome. It takes into account the anatomical structure of sph. Oddi and is&#xD;
      recommended as an alternative to standard sphincterotomy, balloon dilatation and drainage&#xD;
      interventions (RR 0,55 [95%CI 0,18 to 1,67]. ASD must be performed by an endoscopist with&#xD;
      experience in transpapillary intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 21, 2003</start_date>
  <completion_date type="Anticipated">December 21, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 21, 2022</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>
    <intervention_model_description>After the anatomical justification of the structure of the sphincter of Oddi. The technique of sphincterotomy with dissection of only the circular muscle layer of the sphincter of Oddi has been developed. A new knife design has been developed for this technique. The confidence interval and relative risk of complications was determined in patients who are treated with standard methods or with the new method of Dr. Dovbenko.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of participants with the complete removal of stones from bile ducts.</measure>
    <time_frame>During the procedure.</time_frame>
    <description>Complete extraction of stones from the bile ducts is controlled by cholangiogram data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of participants with acute pancreatitis.</measure>
    <time_frame>Up to 12 hours after the procedure.</time_frame>
    <description>Participants suffering from acute pancreatitis after the procedure are considered. Participants suffered one or more symptoms: an increase in serum lipase or amylase above normal, abdominal pain that persists for 24 hours with the need to relieve pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of participants with acute bleeding.</measure>
    <time_frame>From during the procedure to two days after the procedure.</time_frame>
    <description>Participants suffering from acute bleeding after sphincterotomy are considered. Bleeding after sphincterotomy with a drop in hemoglobin&gt; 2 g / dl and requires therapeutic and / or endoscopic methods to stop bleeding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of participants with perforation of duodenum.</measure>
    <time_frame>From one to 3 days after the procedure.</time_frame>
    <description>Clinical manifestation of duodenal perforation after procedure, confirmed by CT or surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of participants with restenosis.</measure>
    <time_frame>From 1 to 5 years after the procedure.</time_frame>
    <description>Restenosis of the sphincter of Oddi is confirmed by CT or cholangiogram. The expansion of the diameter of the common bile duct should be more than 11 mm, and the total bilirubin is increased&gt; 60 mmol / L.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Endoscopic Surgery</condition>
  <arm_group>
    <arm_group_label>Standard sphincterotomy.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard retrograde sphincterotomy is performed on 750 patients using a standard sphincterotome. After deep bile duct cannulation, the standard sphincterotome, the Erlangen &quot;pull-type&quot; model, retrogradely cuts all layers of the wall of the duodenum and sphincter of Oddi. Precut papillotomy using a needle knife used in 20% to improve insert standard sphincterotome to bile duct. The number of patients with complications is calculated: bleeding, perforation, pancreatitis, cholangitis, acute cholecystitis, recurrent cholangiolithiasis, restenosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antegrade sphincterotomy. ASD.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>750 patients underwent a new antegrade sphincterotomy using the new sphincterotome design developed by Dr. Dovbenko (ASD). After deep bile duct cannulation, the new design of sphincterotome, antegradely cuts only circular muscle layer of the sphincter of Oddi. Precut papillotomy using a needle knife used in 20% to improve cannulation new design sphincterotome to bile duct. The number of patients with complications is calculated: bleeding, perforation, pancreatitis, cholangitis, acute cholecystitis, recurrent cholangiolithiasis, restenosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.</intervention_name>
    <description>Sph. Oddi consists of a longitudinal and circular smooth muscle layers. Circular muscle fibers form the pancreatic and duodenal parts. Anatomical justification was cutting of only the circular layer of sph Oddi by special sphincterotome. Papillary stenosis and stenosis terminal part of common bile duct due to damage only circular layer sph Oddi. Anterograde direction and hooked form of sphincterotome (endoscopic antegrade sphincterotomy- ASD) allows to capture only need layer and control depth. Also ASD was performed patient with SOD (I-III) with preservation of the longitudinal muscular layer sph Oddi and septum of papilla.</description>
    <arm_group_label>Antegrade sphincterotomy. ASD.</arm_group_label>
    <other_name>ASD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The antegrade sphincterotome developed by Dr. Dovbenko.</intervention_name>
    <description>A device is represented by a teflon catheter in the distal part of which a double tube of variable shape is created. The proximal part of the ASD sphincterotome consists of a handle, and a metal wire is located inside the teflon catheter for connection to an electrosurgical unit. On the distal part, the teflon catheter is formed of a double tube length is 10 to 35 mm. The metal wire exits the catheter at a distance 10 to 35 mm from the tip and enters into the tip the second teflon tube. The distal part of the knife is formed shape a hook. A metal cutting wire is located between two tubes. Moving the handle the metal wire is shifted. Pushing the metal wire or approaching in the distal part the second tube sets the depth of cut. The incision is made by moving on guidewire in bile duct. The power settings vary.</description>
    <arm_group_label>Antegrade sphincterotomy. ASD.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic sphincterotomy.</intervention_name>
    <description>Endoscopic standard sphincterotomy aims at opening bile duct or pancreatic duct by cutting the papilla and sphincter muscles. After deep bile duct cannulation, the standard sphincterotome is retracted until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary. The extent of the sphincterotomy is limited by the length of the intraduodenal portion of the common bile duct.</description>
    <arm_group_label>Standard sphincterotomy.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The standard sphincterotome.</intervention_name>
    <description>The standard sphincterotome, the Erlangen &quot;pull-type&quot; model, consists of a catheter containing a cautery wire exposed 15 to 25 mm near the tip of the instrument. The leading tip distal to the wire, the &quot;nose,&quot; is 5 to 10 mm in diameter. After deep bile duct cannulation, the sphincterotome is retracted slowly, until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made by lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary.</description>
    <arm_group_label>Standard sphincterotomy.</arm_group_label>
    <other_name>&quot;pull-type&quot; model, the Erlangen.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of Gallstone Disease. Must have anatomy of the esophagus of the stomach&#xD;
        and duodenum for the introduction of a duodenoscope to the major duodenal papilla.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The acute form of viral hepatitis of any etiology. Acute decompensated heart failure&#xD;
        complicated by respiratory failure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>102 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Oleg Dovbenko, MD</last_name>
    <phone>+380682539685</phone>
    <email>dovbenko2015@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Oleg Dovbenko, MD</last_name>
    <phone>+380503161054</phone>
    <email>dovbenko2015@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oleg Dovbenko</name>
      <address>
        <city>Odessa</city>
        <state>Odessa Region</state>
        <zip>65044</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oleg Dovbenko, MD</last_name>
      <phone>+380682539685</phone>
      <email>dovbenko73@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Oleg Dovbenko, MD</last_name>
      <phone>+380503161054</phone>
      <email>dovbenko2015@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Ukraine</country>
  </location_countries>
  <link>
    <url>https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0039-1681738</url>
    <description>Endoscopic transpapillary antegrade sphincterotomy.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/12953410</url>
    <description>Endoscopic papillosphincterotomy: a technique and its methodologies.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/20218365</url>
    <description>Endoscopic correction of biliary duct obstructions of non-tumor origin</description>
  </link>
  <link>
    <url>http://uapatents.com/6-101137-ustatkuvannya-dlya-endoskopichnogo-zovnishno-vnutrishnogo-drenuvannya-protokiv-pechinki-pidshlunkovo-zalozi-porozhnini-abscesu-i-kist-ta-sposib-drenuvannya.html</url>
    <description>Equipment for endoscopic external and internal drainage of the ducts of the liver, pancreas, abscess and cyst cavity and method of drainage</description>
  </link>
  <link>
    <url>https://sis.ukrpatent.org/uk/search/detail/245385/</url>
    <description>Diathermic knife and method of endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 2, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>April 23, 2022</last_update_submitted>
  <last_update_submitted_qc>April 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Military Medical Clinical Center of the Southern Region, Ukraine</investigator_affiliation>
    <investigator_full_name>Oleg Dovbenko, MD</investigator_full_name>
    <investigator_title>Head of the Department of Endoscopic Surgery, Colonel, MD</investigator_title>
  </responsible_party>
  <keyword>endoscopic transpapillary antegrade sphincterotomy (ASD)</keyword>
  <keyword>antegrade sphincterotome</keyword>
  <keyword>preservation of the function of the sph. of Oddi</keyword>
  <keyword>avoid cholecystectomy</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>the highly detailed IPD available in the original CRFs</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>21/01/2021 within 3 months</ipd_time_frame>
    <ipd_access_criteria>personal contact</ipd_access_criteria>
  </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/NCT04406961
org study id: 0682539685
nct id: NCT04406961
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the research has become to create a sphincterotome and a method that takes into
      account the anatomical structure of the sph Oddi. The disadvantages of pull-type
      sphincterotome led to develop a new sphincterotome. The characteristic features of new
      antegrade sphincterotome are: it is inserted ready to use; the direction of cutting is
      strictly determined; fully controlled depth of the cut. Thanks to shaping as it hook the
      sphincterotome has been extracted cutting the circular layer only. The cutting wire is
      located between two teflon catheters preventing the longitudinal muscle layer from being
      damaged. The distance between the catheters determines the depth of the cut. Endoscopic
      transpapillary antegrade sphincterotomy developed by Dr. Dovbenko -(ASD) performance in such
      case allowed: to manage the papillary stenosis; to treat complicated form of gallstone
      disease; In research group this method allowed to avoid cholecystectomy in 71,2 % of cases
Sph of Oddi consists of a circular inner muscle layer and a longitudinal outer muscle layer.
      The circular layer does not depend on the duodenum. The longitudinal layer passes from the
      wall of the duodenum and separates ascending and descending parts superimposing over its
      circular layer. The arrangement of these layers towards each others is constant. Mostly ERCP
      complications are caused by the interventions in major papilla and remain at a high level of
      frequency up to 23 % Cutting all the layers of duodenum leads to bleeding up to 3 %. The
      perforation might happened up to 1 % Destruction of the opening mechanism after
      sphincterotomy leads to develop of reflux cholangitis, acute cholecystitis. It is possible to
      avoid further cholecystectomy only in 10% of patients. Incapability of performing the
      retrograde sphincterotomy in patients with extended papillary stenosis led to the creation of
      a new method - ASD. Retrograde and antegrade sphincterotomies are analysed. 750 patients
      underwent ASD within 7 years 65 % in urgent cases . Relative risk of complication after ASD
      performing 3 times less. Taking into consideration possible post-ASD inner edema, plastic
      biliary/pancreatic stent(s) are required during 5-10 days after. Standard methods for post
      ERCP pancreatitis prevention must be applied in all cases. The new method performed some
      selective. First of all young patient with alone stone in the common bile duct, women after
      after childbirth. secondly, elderly patient were cured by ASD. And as well as a group of
      patients with severe comorbid diseases, such as renal failure, acute myocardial infarction.
      In our research, in two patients with AIDS was performed ASD. They were on special treatment
      after being diagnosed with HIV-infection, within 2 years. It was SSC. Papillary stenosis and
      cholangiolithiasis were cured successfully. The use of ASD with preservation of the closure
      function of the sph. Oddi allowed to avoid cholecystectomy in 71.2%. ASD can be performed new
      design of sphincterotome. It takes into account the anatomical structure of sph. Oddi and is
      recommended as an alternative to standard sphincterotomy, balloon dilatation and drainage
      interventions (RR 0,55 [95%CI 0,18 to 1,67]. ASD must be performed by an endoscopist with
      experience in transpapillary intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: After the anatomical justification of the structure of the sphincter of Oddi. The technique of sphincterotomy with dissection of only the circular muscle layer of the sphincter of Oddi has been developed. A new knife design has been developed for this technique. The confidence interval and relative risk of complications was determined in patients who are treated with standard methods or with the new method of Dr. Dovbenko.
primary purpose: Treatment
masking: Single (Participant)
measure: The number of participants with the complete removal of stones from bile ducts.
time frame: During the procedure.
description: Complete extraction of stones from the bile ducts is controlled by cholangiogram data.
measure: The number of participants with acute pancreatitis.
time frame: Up to 12 hours after the procedure.
description: Participants suffering from acute pancreatitis after the procedure are considered. Participants suffered one or more symptoms: an increase in serum lipase or amylase above normal, abdominal pain that persists for 24 hours with the need to relieve pain.
measure: The number of participants with acute bleeding.
time frame: From during the procedure to two days after the procedure.
description: Participants suffering from acute bleeding after sphincterotomy are considered. Bleeding after sphincterotomy with a drop in hemoglobin> 2 g / dl and requires therapeutic and / or endoscopic methods to stop bleeding.
measure: The number of participants with perforation of duodenum.
time frame: From one to 3 days after the procedure.
description: Clinical manifestation of duodenal perforation after procedure, confirmed by CT or surgery.
measure: The number of participants with restenosis.
time frame: From 1 to 5 years after the procedure.
description: Restenosis of the sphincter of Oddi is confirmed by CT or cholangiogram. The expansion of the diameter of the common bile duct should be more than 11 mm, and the total bilirubin is increased> 60 mmol / L.
arm group label: Standard sphincterotomy.
arm group type: Active Comparator
description: Standard retrograde sphincterotomy is performed on 750 patients using a standard sphincterotome. After deep bile duct cannulation, the standard sphincterotome, the Erlangen "pull-type" model, retrogradely cuts all layers of the wall of the duodenum and sphincter of Oddi. Precut papillotomy using a needle knife used in 20% to improve insert standard sphincterotome to bile duct. The number of patients with complications is calculated: bleeding, perforation, pancreatitis, cholangitis, acute cholecystitis, recurrent cholangiolithiasis, restenosis.
arm group label: Antegrade sphincterotomy. ASD.
arm group type: Active Comparator
description: 750 patients underwent a new antegrade sphincterotomy using the new sphincterotome design developed by Dr. Dovbenko (ASD). After deep bile duct cannulation, the new design of sphincterotome, antegradely cuts only circular muscle layer of the sphincter of Oddi. Precut papillotomy using a needle knife used in 20% to improve cannulation new design sphincterotome to bile duct. The number of patients with complications is calculated: bleeding, perforation, pancreatitis, cholangitis, acute cholecystitis, recurrent cholangiolithiasis, restenosis.
intervention type: Procedure
intervention name: Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.
description: Sph. Oddi consists of a longitudinal and circular smooth muscle layers. Circular muscle fibers form the pancreatic and duodenal parts. Anatomical justification was cutting of only the circular layer of sph Oddi by special sphincterotome. Papillary stenosis and stenosis terminal part of common bile duct due to damage only circular layer sph Oddi. Anterograde direction and hooked form of sphincterotome (endoscopic antegrade sphincterotomy- ASD) allows to capture only need layer and control depth. Also ASD was performed patient with SOD (I-III) with preservation of the longitudinal muscular layer sph Oddi and septum of papilla.
arm group label: Antegrade sphincterotomy. ASD.
other name: ASD
intervention type: Device
intervention name: The antegrade sphincterotome developed by Dr. Dovbenko.
description: A device is represented by a teflon catheter in the distal part of which a double tube of variable shape is created. The proximal part of the ASD sphincterotome consists of a handle, and a metal wire is located inside the teflon catheter for connection to an electrosurgical unit. On the distal part, the teflon catheter is formed of a double tube length is 10 to 35 mm. The metal wire exits the catheter at a distance 10 to 35 mm from the tip and enters into the tip the second teflon tube. The distal part of the knife is formed shape a hook. A metal cutting wire is located between two tubes. Moving the handle the metal wire is shifted. Pushing the metal wire or approaching in the distal part the second tube sets the depth of cut. The incision is made by moving on guidewire in bile duct. The power settings vary.
arm group label: Antegrade sphincterotomy. ASD.
intervention type: Procedure
intervention name: Endoscopic sphincterotomy.
description: Endoscopic standard sphincterotomy aims at opening bile duct or pancreatic duct by cutting the papilla and sphincter muscles. After deep bile duct cannulation, the standard sphincterotome is retracted until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary. The extent of the sphincterotomy is limited by the length of the intraduodenal portion of the common bile duct.
arm group label: Standard sphincterotomy.
intervention type: Device
intervention name: The standard sphincterotome.
description: The standard sphincterotome, the Erlangen "pull-type" model, consists of a catheter containing a cautery wire exposed 15 to 25 mm near the tip of the instrument. The leading tip distal to the wire, the "nose," is 5 to 10 mm in diameter. After deep bile duct cannulation, the sphincterotome is retracted slowly, until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made by lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary.
arm group label: Standard sphincterotomy.
other name: "pull-type" model, the Erlangen.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 102 Years
healthy volunteers: No
last name: Oleg Dovbenko, MD
phone: +380682539685
email: dovbenko2015@hotmail.com
last name: Oleg Dovbenko, MD
phone: +380503161054
email: dovbenko2015@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Ukraine
url: https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0039-1681738
description: Endoscopic transpapillary antegrade sphincterotomy.
url: https://www.ncbi.nlm.nih.gov/pubmed/12953410
description: Endoscopic papillosphincterotomy: a technique and its methodologies.
url: https://www.ncbi.nlm.nih.gov/pubmed/20218365
description: Endoscopic correction of biliary duct obstructions of non-tumor origin
url: http://uapatents.com/6-101137-ustatkuvannya-dlya-endoskopichnogo-zovnishno-vnutrishnogo-drenuvannya-protokiv-pechinki-pidshlunkovo-zalozi-porozhnini-abscesu-i-kist-ta-sposib-drenuvannya.html
description: Equipment for endoscopic external and internal drainage of the ducts of the liver, pancreas, abscess and cyst cavity and method of drainage
url: https://sis.ukrpatent.org/uk/search/detail/245385/
description: Diathermic knife and method of endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.
responsible party type: Principal Investigator
investigator affiliation: Military Medical Clinical Center of the Southern Region, Ukraine
investigator full name: Oleg Dovbenko, MD
investigator title: Head of the Department of Endoscopic Surgery, Colonel, MD
sharing ipd: Yes
ipd description: the highly detailed IPD available in the original CRFs
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 21/01/2021 within 3 months
ipd access criteria: personal contact