<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/NCT03277937</url>
  </required_header>
  <id_info>
    <org_study_id>JULY 20-2017</org_study_id>
    <nct_id>NCT03277937</nct_id>
  </id_info>
  <brief_title>Angiography for Evaluation of the Feeder Vessel in EUS-guided Coils and Cyanoacrylate Therapy for Gastric Varices</brief_title>
  <official_title>The Use of Angiography for Determination and Confirmation of the Feeder Vessel as a Modification of the Original EUS-guided Coils and Cyanoacrylate Therapy for Gastric Varices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Ecuatoriano de Enfermedades Digestivas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Ecuatoriano de Enfermedades Digestivas</source>
  <oversight_info>
    <has_dmc>Yes</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>
      INTRODUCTION: Bleeding from gastric varices (GV) is associated with a high mortality rate.&#xD;
      Injection of cyanoacrylate (CYA) using standard gastroscope has demonstrated to achieve&#xD;
      higher hemostasis and lower rebleeding rates compared to band ligation or sclerotherapy.&#xD;
      Nevertheless CYA treatment is known to be associated with significant adverse events.&#xD;
      Pulmonary embolism due to CYA injection is a serious and sometimes fatal complication of this&#xD;
      therapy. These patients usually have respiratory symptom, however this complication can be&#xD;
      present in asymptomatic patients, being demonstrated only by a pathological CT scan. On the&#xD;
      other hand, it has been described that the risk of glue embolism dependent on the volume of&#xD;
      CYA injected, being significantly greater with high volumes. Other complications related to&#xD;
      CYA injection are hemorrhage from injection site ulcers, fever, peritonitis, needle&#xD;
      impaction, and even death. Also the injection material can cause serious damage to the&#xD;
      endoscope.&#xD;
&#xD;
      Currently, endoscopic injection of CYA can be performed by direct visualization using a&#xD;
      standard gastroscope or guided by Endoscopic Ultrasound (EUS) with injection of CYA alone or&#xD;
      in combination with coils. The injection of coils in conjunction with CYA may reduce or&#xD;
      eliminate the risk of glue embolization as coils can function as a scaffold to retain CYA&#xD;
      within the varix and may decrease the amount of glue injection needed to achieve&#xD;
      obliteration. It has been previously demonstrated that treatment under EUS guidance may have&#xD;
      some benefits. It allows a precise targeting of the varix lumen or afferent feeding veins,&#xD;
      being the vessel obstructed with less amount of CYA than used for the &quot;blind&quot; injection by&#xD;
      standard endoscopy, reducing the risk of glue embolism. EUS can confirm varix obliteration by&#xD;
      Doppler effect and also the visualization of GV is not impaired by blood or food in the&#xD;
      stomach, thus it can be used in the setting of active hemorrhage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On the other hand, despite the EUS-injection of coils and CYA have shown very promising&#xD;
      results, it is extremely important to have experience performing this technique, as the&#xD;
      injection in a wrong vessel could be catastrophic. It has been develop in our unit a&#xD;
      modification of Binmoeller´s original technique by performing the injection of coils and CYA&#xD;
      by EUS and fluoroscopic guidance. The performance of an angiography guided by EUS and under&#xD;
      fluoroscopy evaluation, represents a modification to the original technique that add some&#xD;
      benefits: 1) The injection of water-soluble contrast allows identifying the variceal flow and&#xD;
      the afferent feeding vessel (left gastric vein) and avoiding splenic vessels embolization. 2)&#xD;
      Also, if there is a shunt it can be detected and the injection of CYA can be avoided. 3) In&#xD;
      case of active bleeding the angiography allows visualizing which varix is bleeding, and&#xD;
      target the correct vessel.&#xD;
&#xD;
      The aim of this study is to show the results and potential benefits by adding an angiography&#xD;
      to the original EUS-guided injection of coils in combination with CYA technique, to&#xD;
      determinate and confirm the feeder vessel in GV treatment.&#xD;
&#xD;
      MATERIALS AND METHODS&#xD;
&#xD;
      Study design: It will be an interventional, descriptive and prospective study, performed in&#xD;
      the Ecuadorian Institute of Digestive Disease (IECED), Omni Hospital Academic Tertiary Center&#xD;
      Ecuador. Patients have been included from July 2015 and will continue to be included up to&#xD;
      October 2017. The study protocol and consent form has been approved by the institutional&#xD;
      review board, and will be conducted according to the declaration of Helsinki. Written&#xD;
      informed consent will be obtained from all subjects.&#xD;
&#xD;
      Population selection, inclusion and exclusion criteria: Patients above 18 years old with&#xD;
      gastric varices (GV) on the initial standard diagnostic upper endoscopy will be enrolled. GV&#xD;
      will be classified according to Sarin and Kumar classification. Only gastro-esophageal&#xD;
      varices type II (GOV II) (fundal varices communicating with esophageal varices) and isolated&#xD;
      gastric varices type I (IGV I) (fundal varices within a few centimeters of the gastric&#xD;
      cardia) will be included. Gastro-esophageal varices type I (GOV I) will be excluded as they&#xD;
      can be successfully treated by endoscopic band ligation. Patients with active bleeding and&#xD;
      history of previous bleeding due to GV (secondary prophylaxis) will be included as well as&#xD;
      patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus.&#xD;
      The exclusion criteria will be pregnancy, concurrent hepatorenal syndrome and/or multi-organ&#xD;
      failure, platelet count less than 50,000/ml or International Normalized Rate (INR) &gt;2,&#xD;
      esophageal stricture, splenic or portal vein thrombosis and allergy to iodine.&#xD;
&#xD;
      Endoscopic Procedure and Technique: All procedures will be performed in a hospital-based&#xD;
      interventional endoscopy setting, where radiology is available and by one endoscopist&#xD;
      (C.R.M), under general anesthesia, with tracheal intubation, with the patient in supine&#xD;
      position and using antibiotic prophylaxis. EUS examination will be performed using a 3.8 mm&#xD;
      working channel linear-array therapeutic echoendoscopes (EG 3870UTK; Pentax, Hamburg,&#xD;
      Germany), attached to an ultrasound console (Avius Hitachi, Tokyo, Japan). The echoendoscope&#xD;
      will be positioned in the distal esophagus at the level of the cardia (anterograde&#xD;
      trans-esophageal, transcrural approach) to visualize the gastric fundus and intramural&#xD;
      varices.&#xD;
&#xD;
      Detection of the feeder vessel by EUS: Once positioned, water will be instilled to fill the&#xD;
      gastric fundus, in order to improve acoustic coupling and visualization of GV. EUS color&#xD;
      Doppler imaging will be used to allow direct visualization of the varices flow. Following the&#xD;
      gastric vessel, and by using the fine-flow doppler color of the ultrasound console, the&#xD;
      vessel or vessels will be followed from the cardia (distal part of the esophagus) to the&#xD;
      proximal part of the esophagus (2 to 3 cm) above the cardia, to detect the feeding vessel.&#xD;
      The feeding vessel is characterized by the convergence of all vessels. Once the feeding&#xD;
      vessel has been found, a 19 gauge EUS-fine needle aspiration (FNA) (Expect® flexible; Boston&#xD;
      Scientific®, Marlborough, USA) will be used to access the vessel, the stylet will be&#xD;
      withdrawn and a 20 ml syringe with negative pressure will be used to evaluate blood return,&#xD;
      confirming intravascular location. In order to prevent blood clotting of the needle tip, 5 ml&#xD;
      of saline solution will be instilled. Moreover, the flush with saline solution allows to&#xD;
      confirm the flow of the gastric vessels under B-mode ultrasound visualization.&#xD;
&#xD;
      Using angiography to confirm the target vessel (feeder vessel) and flow traject: In the final&#xD;
      diagnostic step, an angiography will be performed using 5 to 10 mL of water-soluble contrast&#xD;
      (Ultravist, Bayer, Ecuador) under fluoroscopic evaluation, in order to ensure intravascular&#xD;
      location and study varix flow direction (afferent or efferent). Angiography technical success&#xD;
      will be measured, determined as the possibility to define the flow trajectory vessel under&#xD;
      fluoroscopy.&#xD;
&#xD;
      EUS-guided deployment of Coils and Cyanoacrylate injection: Finally, patients will be treated&#xD;
      by EUS-deployment of coils followed by CYA injection. The intravascular embolization coils&#xD;
      that will be used (10-16 mm coiled diameter, 12-20 cm straight lengths, 0.035 inches&#xD;
      diameter, Nester Embolization Coil; Cook Medical) will be delivered into the vessel through&#xD;
      the FNA needle, using the stylet as a pusher. Special attention will be paid not place the&#xD;
      needle tip on the counter wall due to the risk of perforation, bleed, coil extrusion and to&#xD;
      allow enough space for the coil to curl.&#xD;
&#xD;
      The CYA that will be used is the 2-Octyl-CYA (Dermabond; Ethicon, Piscataway, NJ). It will be&#xD;
      injected always after the coils are deployed and then 1 mL of saline solution will be used to&#xD;
      flush the glue completely through the needle. The diameter (10-16 mm), number of coils and&#xD;
      the volume of the 2-Octyl-CYA injected will be calculated according to the diameter of the&#xD;
      vessel measured on EUS and by the angiography of the vessel. After 30 seconds, once CYA has&#xD;
      been solidified and the risk of bleeding on the puncturing site decrease, the needle will be&#xD;
      withdrawn. Obliteration of the vessel will be confirmed 3 minutes later using Doppler&#xD;
      imaging. Complete obliteration of the treated varix will be defined as absence of Doppler&#xD;
      flow on EUS.&#xD;
&#xD;
      A direct visualization of the gastric varices will be performed after the EUS procedure to&#xD;
      determine the effect of the obliteration of the feeder vessel by using a standard&#xD;
      videoendoscope. After the procedure, patients will be observed for 2 hours in the recovery&#xD;
      room before being discharged of the unit. In cases of primary prophylaxis the treatment will&#xD;
      be ambulatory.&#xD;
&#xD;
      Finally, a 1, 3, 9 and 12 months follow-up will be performed in order to confirm the results&#xD;
      of the EUS-therapeutic by EUS and by upper endoscopy.&#xD;
&#xD;
      Technical success will be considered as target of the vessels and deployment of the proposed&#xD;
      EUS-therapeutic. Treatment failure and early rebleeding will be considered when bleeding&#xD;
      occurred the first five days and between 5 and 90 days respectively.&#xD;
&#xD;
      Statistical analysis: Demographic characteristics, previous medication and radiological&#xD;
      images will be described. Quantitative variables will be described in mean or median, and&#xD;
      standard deviation or range, as corresponding. Qualitative variables will be described in&#xD;
      percentages. A Kolmogorov-Smirnov test with a p value &lt;0.05 will be considered to be&#xD;
      statistically significant. The IECED institutional biostatistician will review statistical&#xD;
      methodology of the study. Statistical calculations will be performed in SPSS software suite&#xD;
      v.22.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>efficacy of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate, confirm and target the feeder vessel in GV treatment.</measure>
    <time_frame>12 months</time_frame>
    <description>efficacy will be considered be the complete occlusion and/or disappearance of the GV and will be determinate by follow-up controls using EUS and upper endoscopy. Treatment failure and early rebleeding will be considered when bleeding occurred the first five days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>safety of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate and confirm the feeder vessel in GV treatment</measure>
    <time_frame>12 months</time_frame>
    <description>all adverse events related to the technique during the procedure or the follow-up will be described.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Gastric Varices</condition>
  <arm_group>
    <arm_group_label>Patients with gastric varices</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients above 18 years old with gastric varices (GV) on the initial standard diagnostic upper endoscopy will be enrolled and treated using angiography in EUS-injection of coils + CYA. GV will be classified according to Sarin and Kumar classification. Only gastro-esophageal varices type II (GOV II) (fundal varices communicating with esophageal varices) and isolated gastric varices type I (IGV I) (fundal varices within a few centimeters of the gastric cardia) will be included. Gastro-esophageal varices type I (GOV I) will be excluded. Patients with active bleeding and history of previous bleeding due to GV (secondary prophylaxis) will be included as well as patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus. T</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>angiography in EUS-injection of coils + CYA</intervention_name>
    <description>Doppler imaging will be used to allow direct visualization of the varices flow. The gastric vessels will be followed from the cardia to the proximal part of the esophagus, to detect the feeding vessel (FV). Once the FV has been found, a 19-gauge EUS-FNA will be used to access the vessel. An angiography will be performed using 5-10 ml of water-soluble contrast under fluoroscopy, to ensure intravascular location and study varix flow direction. Finally, patients will be treated by EUS-deployment of coils followed by CYA injection. The coils will be delivered into the vessel through the FNA needle, using the stylet as a pusher. The 2-Octyl-CYA will be used. It will be injected always after the coils deployment and then 1 mL of saline solution will be used to flush the glue completely.</description>
    <arm_group_label>Patients with gastric varices</arm_group_label>
    <other_name>Drug: cyanoacrylate</other_name>
    <other_name>Device: coils</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients above 18 years old with gastric varices (GV) on the initial standard&#xD;
             diagnostic upper endoscopy will be enrolled. GV will be classified&#xD;
&#xD;
          -  Only gastro-esophageal varices type II (GOV II) (fundal varices communicating with&#xD;
             esophageal varices) and isolated gastric varices type I (IGV I) (fundal varices within&#xD;
             a few centimeters of the gastric cardia) will be included (according to Sarin and&#xD;
             Kumar classification).&#xD;
&#xD;
          -  Patients with active bleeding and history of previous bleeding due to GV (secondary&#xD;
             prophylaxis)&#xD;
&#xD;
          -  Patients with high-risk GV suitable for primary prophylaxis according to Baveno VI&#xD;
             consensus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastro-esophageal varices type I (GOV I) will be excluded as they can be successfully&#xD;
             treated by endoscopic band ligation.&#xD;
&#xD;
          -  Pregnancy,&#xD;
&#xD;
          -  Hepatorenal syndrome&#xD;
&#xD;
          -  Multi-organ failure,&#xD;
&#xD;
          -  platelet count less than 50,000/ml&#xD;
&#xD;
          -  International Normalized Rate (INR) &gt;2,&#xD;
&#xD;
          -  esophageal stricture,&#xD;
&#xD;
          -  Splenic vein thrombosis&#xD;
&#xD;
          -  Portal vein thrombosis&#xD;
&#xD;
          -  Allergy to iodine.&#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>Carlos A Robles-Medranda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ecuadorian Institute of Digestive Diseases</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ecuadorian Institute of Digestive Diseases, Omnihospital</name>
      <address>
        <city>Guayaquil</city>
        <state>Guayas</state>
        <zip>090505</zip>
        <country>Ecuador</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ecuador</country>
  </location_countries>
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  </results_reference>
  <results_reference>
    <citation>Binmoeller KF, Weilert F, Shah JN, Kim J. EUS-guided transesophageal treatment of gastric fundal varices with combined coiling and cyanoacrylate glue injection (with videos). Gastrointest Endosc. 2011 Nov;74(5):1019-25. doi: 10.1016/j.gie.2011.06.030. Epub 2011 Sep 1.</citation>
    <PMID>21889139</PMID>
  </results_reference>
  <results_reference>
    <citation>Sarin SK, Kumar A. Gastric varices: profile, classification, and management. Am J Gastroenterol. 1989 Oct;84(10):1244-9.</citation>
    <PMID>2679046</PMID>
  </results_reference>
  <results_reference>
    <citation>de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.</citation>
    <PMID>26047908</PMID>
  </results_reference>
  <results_reference>
    <citation>Gianotti R, Charles H, Hymes K, Chandarana H, Sigal S. Treatment of gastric varices with partial splenic embolization in a patient with portal vein thrombosis and a myeloproliferative disorder. World J Gastroenterol. 2014 Oct 21;20(39):14495-9. doi: 10.3748/wjg.v20.i39.14495.</citation>
    <PMID>25339837</PMID>
  </results_reference>
  <results_reference>
    <citation>Rengstorff DS, Binmoeller KF. A pilot study of 2-octyl cyanoacrylate injection for treatment of gastric fundal varices in humans. Gastrointest Endosc. 2004 Apr;59(4):553-8. doi: 10.1016/s0016-5107(03)02865-7.</citation>
    <PMID>15044898</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>November 18, 2018</last_update_submitted>
  <last_update_submitted_qc>November 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastric varices</keyword>
  <keyword>endoscopic ultrasound</keyword>
  <keyword>coils</keyword>
  <keyword>cyanoacrylate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal and Gastric Varices</mesh_term>
    <mesh_term>Varicose Veins</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03277937
org study id: JULY 20-2017
nct id: NCT03277937
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
INTRODUCTION: Bleeding from gastric varices (GV) is associated with a high mortality rate.
      Injection of cyanoacrylate (CYA) using standard gastroscope has demonstrated to achieve
      higher hemostasis and lower rebleeding rates compared to band ligation or sclerotherapy.
      Nevertheless CYA treatment is known to be associated with significant adverse events.
      Pulmonary embolism due to CYA injection is a serious and sometimes fatal complication of this
      therapy. These patients usually have respiratory symptom, however this complication can be
      present in asymptomatic patients, being demonstrated only by a pathological CT scan. On the
      other hand, it has been described that the risk of glue embolism dependent on the volume of
      CYA injected, being significantly greater with high volumes. Other complications related to
      CYA injection are hemorrhage from injection site ulcers, fever, peritonitis, needle
      impaction, and even death. Also the injection material can cause serious damage to the
      endoscope.

      Currently, endoscopic injection of CYA can be performed by direct visualization using a
      standard gastroscope or guided by Endoscopic Ultrasound (EUS) with injection of CYA alone or
      in combination with coils. The injection of coils in conjunction with CYA may reduce or
      eliminate the risk of glue embolization as coils can function as a scaffold to retain CYA
      within the varix and may decrease the amount of glue injection needed to achieve
      obliteration. It has been previously demonstrated that treatment under EUS guidance may have
      some benefits. It allows a precise targeting of the varix lumen or afferent feeding veins,
      being the vessel obstructed with less amount of CYA than used for the "blind" injection by
      standard endoscopy, reducing the risk of glue embolism. EUS can confirm varix obliteration by
      Doppler effect and also the visualization of GV is not impaired by blood or food in the
      stomach, thus it can be used in the setting of active hemorrhage.
On the other hand, despite the EUS-injection of coils and CYA have shown very promising
      results, it is extremely important to have experience performing this technique, as the
      injection in a wrong vessel could be catastrophic. It has been develop in our unit a
      modification of Binmoeller´s original technique by performing the injection of coils and CYA
      by EUS and fluoroscopic guidance. The performance of an angiography guided by EUS and under
      fluoroscopy evaluation, represents a modification to the original technique that add some
      benefits: 1) The injection of water-soluble contrast allows identifying the variceal flow and
      the afferent feeding vessel (left gastric vein) and avoiding splenic vessels embolization. 2)
      Also, if there is a shunt it can be detected and the injection of CYA can be avoided. 3) In
      case of active bleeding the angiography allows visualizing which varix is bleeding, and
      target the correct vessel.

      The aim of this study is to show the results and potential benefits by adding an angiography
      to the original EUS-guided injection of coils in combination with CYA technique, to
      determinate and confirm the feeder vessel in GV treatment.

      MATERIALS AND METHODS

      Study design: It will be an interventional, descriptive and prospective study, performed in
      the Ecuadorian Institute of Digestive Disease (IECED), Omni Hospital Academic Tertiary Center
      Ecuador. Patients have been included from July 2015 and will continue to be included up to
      October 2017. The study protocol and consent form has been approved by the institutional
      review board, and will be conducted according to the declaration of Helsinki. Written
      informed consent will be obtained from all subjects.

      Population selection, inclusion and exclusion criteria: Patients above 18 years old with
      gastric varices (GV) on the initial standard diagnostic upper endoscopy will be enrolled. GV
      will be classified according to Sarin and Kumar classification. Only gastro-esophageal
      varices type II (GOV II) (fundal varices communicating with esophageal varices) and isolated
      gastric varices type I (IGV I) (fundal varices within a few centimeters of the gastric
      cardia) will be included. Gastro-esophageal varices type I (GOV I) will be excluded as they
      can be successfully treated by endoscopic band ligation. Patients with active bleeding and
      history of previous bleeding due to GV (secondary prophylaxis) will be included as well as
      patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus.
      The exclusion criteria will be pregnancy, concurrent hepatorenal syndrome and/or multi-organ
      failure, platelet count less than 50,000/ml or International Normalized Rate (INR) >2,
      esophageal stricture, splenic or portal vein thrombosis and allergy to iodine.

      Endoscopic Procedure and Technique: All procedures will be performed in a hospital-based
      interventional endoscopy setting, where radiology is available and by one endoscopist
      (C.R.M), under general anesthesia, with tracheal intubation, with the patient in supine
      position and using antibiotic prophylaxis. EUS examination will be performed using a 3.8 mm
      working channel linear-array therapeutic echoendoscopes (EG 3870UTK; Pentax, Hamburg,
      Germany), attached to an ultrasound console (Avius Hitachi, Tokyo, Japan). The echoendoscope
      will be positioned in the distal esophagus at the level of the cardia (anterograde
      trans-esophageal, transcrural approach) to visualize the gastric fundus and intramural
      varices.

      Detection of the feeder vessel by EUS: Once positioned, water will be instilled to fill the
      gastric fundus, in order to improve acoustic coupling and visualization of GV. EUS color
      Doppler imaging will be used to allow direct visualization of the varices flow. Following the
      gastric vessel, and by using the fine-flow doppler color of the ultrasound console, the
      vessel or vessels will be followed from the cardia (distal part of the esophagus) to the
      proximal part of the esophagus (2 to 3 cm) above the cardia, to detect the feeding vessel.
      The feeding vessel is characterized by the convergence of all vessels. Once the feeding
      vessel has been found, a 19 gauge EUS-fine needle aspiration (FNA) (Expect® flexible; Boston
      Scientific®, Marlborough, USA) will be used to access the vessel, the stylet will be
      withdrawn and a 20 ml syringe with negative pressure will be used to evaluate blood return,
      confirming intravascular location. In order to prevent blood clotting of the needle tip, 5 ml
      of saline solution will be instilled. Moreover, the flush with saline solution allows to
      confirm the flow of the gastric vessels under B-mode ultrasound visualization.

      Using angiography to confirm the target vessel (feeder vessel) and flow traject: In the final
      diagnostic step, an angiography will be performed using 5 to 10 mL of water-soluble contrast
      (Ultravist, Bayer, Ecuador) under fluoroscopic evaluation, in order to ensure intravascular
      location and study varix flow direction (afferent or efferent). Angiography technical success
      will be measured, determined as the possibility to define the flow trajectory vessel under
      fluoroscopy.

      EUS-guided deployment of Coils and Cyanoacrylate injection: Finally, patients will be treated
      by EUS-deployment of coils followed by CYA injection. The intravascular embolization coils
      that will be used (10-16 mm coiled diameter, 12-20 cm straight lengths, 0.035 inches
      diameter, Nester Embolization Coil; Cook Medical) will be delivered into the vessel through
      the FNA needle, using the stylet as a pusher. Special attention will be paid not place the
      needle tip on the counter wall due to the risk of perforation, bleed, coil extrusion and to
      allow enough space for the coil to curl.

      The CYA that will be used is the 2-Octyl-CYA (Dermabond; Ethicon, Piscataway, NJ). It will be
      injected always after the coils are deployed and then 1 mL of saline solution will be used to
      flush the glue completely through the needle. The diameter (10-16 mm), number of coils and
      the volume of the 2-Octyl-CYA injected will be calculated according to the diameter of the
      vessel measured on EUS and by the angiography of the vessel. After 30 seconds, once CYA has
      been solidified and the risk of bleeding on the puncturing site decrease, the needle will be
      withdrawn. Obliteration of the vessel will be confirmed 3 minutes later using Doppler
      imaging. Complete obliteration of the treated varix will be defined as absence of Doppler
      flow on EUS.

      A direct visualization of the gastric varices will be performed after the EUS procedure to
      determine the effect of the obliteration of the feeder vessel by using a standard
      videoendoscope. After the procedure, patients will be observed for 2 hours in the recovery
      room before being discharged of the unit. In cases of primary prophylaxis the treatment will
      be ambulatory.

      Finally, a 1, 3, 9 and 12 months follow-up will be performed in order to confirm the results
      of the EUS-therapeutic by EUS and by upper endoscopy.

      Technical success will be considered as target of the vessels and deployment of the proposed
      EUS-therapeutic. Treatment failure and early rebleeding will be considered when bleeding
      occurred the first five days and between 5 and 90 days respectively.

      Statistical analysis: Demographic characteristics, previous medication and radiological
      images will be described. Quantitative variables will be described in mean or median, and
      standard deviation or range, as corresponding. Qualitative variables will be described in
      percentages. A Kolmogorov-Smirnov test with a p value <0.05 will be considered to be
      statistically significant. The IECED institutional biostatistician will review statistical
      methodology of the study. Statistical calculations will be performed in SPSS software suite
      v.22.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: efficacy of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate, confirm and target the feeder vessel in GV treatment.
time frame: 12 months
description: efficacy will be considered be the complete occlusion and/or disappearance of the GV and will be determinate by follow-up controls using EUS and upper endoscopy. Treatment failure and early rebleeding will be considered when bleeding occurred the first five days.
measure: safety of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate and confirm the feeder vessel in GV treatment
time frame: 12 months
description: all adverse events related to the technique during the procedure or the follow-up will be described.
arm group label: Patients with gastric varices
arm group type: Experimental
description: Patients above 18 years old with gastric varices (GV) on the initial standard diagnostic upper endoscopy will be enrolled and treated using angiography in EUS-injection of coils + CYA. GV will be classified according to Sarin and Kumar classification. Only gastro-esophageal varices type II (GOV II) (fundal varices communicating with esophageal varices) and isolated gastric varices type I (IGV I) (fundal varices within a few centimeters of the gastric cardia) will be included. Gastro-esophageal varices type I (GOV I) will be excluded. Patients with active bleeding and history of previous bleeding due to GV (secondary prophylaxis) will be included as well as patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus. T
intervention type: Procedure
intervention name: angiography in EUS-injection of coils + CYA
description: Doppler imaging will be used to allow direct visualization of the varices flow. The gastric vessels will be followed from the cardia to the proximal part of the esophagus, to detect the feeding vessel (FV). Once the FV has been found, a 19-gauge EUS-FNA will be used to access the vessel. An angiography will be performed using 5-10 ml of water-soluble contrast under fluoroscopy, to ensure intravascular location and study varix flow direction. Finally, patients will be treated by EUS-deployment of coils followed by CYA injection. The coils will be delivered into the vessel through the FNA needle, using the stylet as a pusher. The 2-Octyl-CYA will be used. It will be injected always after the coils deployment and then 1 mL of saline solution will be used to flush the glue completely.
arm group label: Patients with gastric varices
other name: Drug: cyanoacrylate
other name: Device: coils
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlos A Robles-Medranda, MD
role: Principal Investigator
affiliation: Ecuadorian Institute of Digestive Diseases
facility: 
country: Ecuador
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PMID: 26139494
citation: Binmoeller KF, Weilert F, Shah JN, Kim J. EUS-guided transesophageal treatment of gastric fundal varices with combined coiling and cyanoacrylate glue injection (with videos). Gastrointest Endosc. 2011 Nov;74(5):1019-25. doi: 10.1016/j.gie.2011.06.030. Epub 2011 Sep 1.
PMID: 21889139
citation: Sarin SK, Kumar A. Gastric varices: profile, classification, and management. Am J Gastroenterol. 1989 Oct;84(10):1244-9.
PMID: 2679046
citation: de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
PMID: 26047908
citation: Gianotti R, Charles H, Hymes K, Chandarana H, Sigal S. Treatment of gastric varices with partial splenic embolization in a patient with portal vein thrombosis and a myeloproliferative disorder. World J Gastroenterol. 2014 Oct 21;20(39):14495-9. doi: 10.3748/wjg.v20.i39.14495.
PMID: 25339837
citation: Rengstorff DS, Binmoeller KF. A pilot study of 2-octyl cyanoacrylate injection for treatment of gastric fundal varices in humans. Gastrointest Endosc. 2004 Apr;59(4):553-8. doi: 10.1016/s0016-5107(03)02865-7.
PMID: 15044898
responsible party type: Sponsor
mesh term: Esophageal and Gastric Varices
mesh term: Varicose Veins
sharing ipd: Undecided