<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/NCT03259763</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00128878</org_study_id>
    <nct_id>NCT03259763</nct_id>
  </id_info>
  <brief_title>EUS-GE vs ES for Palliation of Gastric Outlet Obstruction</brief_title>
  <official_title>EUS-guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is&#xD;
      associated with substantial morbidity. Palliation of GOO has traditionally been through the&#xD;
      surgical bypass of the obstructed lumen by creating an opening between the stomach and small&#xD;
      intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has&#xD;
      gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this&#xD;
      study, the investigators are going to compare the safety and efficacy of the two different&#xD;
      endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE)&#xD;
      and enteral stenting (ES).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, Enteral Stenting (ES) has commonly been used as the first line management of&#xD;
      unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic&#xD;
      ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique&#xD;
      for palliation of malignant GOO, which has the theoretical potential to minimize the risk for&#xD;
      stent occlusion while maintaining the less invasive endoscopic approach. This novel&#xD;
      endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby&#xD;
      bypassing the occluded lumen. This endoscopic technique has been performed to treat patients&#xD;
      with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable&#xD;
      to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly&#xD;
      decreased risk of recurrent GOO and reinterventions.&#xD;
&#xD;
      Based on the investigator's clinical experience for the last three years and the&#xD;
      above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with&#xD;
      ES in the management of unresectable malignant gastric outlet obstruction. The investigators&#xD;
      hypothesize that EUS-GE is associated with comparable technical and clinical success and&#xD;
      safety profile while requiring fewer re-interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 26, 2020</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of gastric outlet obstruction recurrence</measure>
    <time_frame>3 months</time_frame>
    <description>Recurrence of nausea, vomiting, and inability to tolerate PO intake up to 3 months after the procedure confirmed either endoscopically and/or radiographically.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success rate</measure>
    <time_frame>Day of procedure</time_frame>
    <description>Adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success rate</measure>
    <time_frame>1 week</time_frame>
    <description>The improvement of at least 1 point in the gastric outlet obstruction score within 7 days after stent insertion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of procedure</measure>
    <time_frame>Day of procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events rate</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-procedure length of hospital stay</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reintervention rate for recurrent gastric outlet obstruction</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life SF-36 questionnaire scoring</measure>
    <time_frame>3 months</time_frame>
    <description>The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrent gastric outlet obstruction</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric Outlet Obstruction Scoring system (GOOSS)</measure>
    <time_frame>1 year</time_frame>
    <description>Diet toleration will be scored based on the Gastric Outlet Obstruction Scoring System (GOOSS). The scoring ranges from 0 to 3 in the following format:&#xD;
0 = no oral intake, 1 = liquids only, 2 = soft solids, 3 = low-residue or full diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Dysfunction Rate</measure>
    <time_frame>3 months</time_frame>
    <description>the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of stent patency</measure>
    <time_frame>3 months</time_frame>
    <description>Calculated from the time of stent placement to the time of stent dysfunction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Gastric Outlet Obstruction</condition>
  <arm_group>
    <arm_group_label>EUS-guided gastroenterostomy (EUS-GE)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enteral Stenting (ES)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lumen-apposing metal stent</intervention_name>
    <description>In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.</description>
    <arm_group_label>EUS-guided gastroenterostomy (EUS-GE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Self-expandable metal stent</intervention_name>
    <description>In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.</description>
    <arm_group_label>Enteral Stenting (ES)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with malignant, symptomatic gastric outlet obstruction due to an&#xD;
             unresectable malignant lesion&#xD;
&#xD;
          -  Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1&#xD;
             (liquids only)&#xD;
&#xD;
          -  Age&gt;= 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of other strictures in the gastrointestinal (GI) tract&#xD;
&#xD;
          -  Previous gastric, periampullary or duodenal surgery&#xD;
&#xD;
          -  World Health Organization (WHO) performance score of 4 (patient is 100% of time in&#xD;
             bed)&#xD;
&#xD;
          -  Unable to fill out quality of life questionnaire&#xD;
&#xD;
          -  Unable to sign the informed consent&#xD;
&#xD;
          -  Cancer extending into the body of the stomach, 4th portion of the duodenum or proximal&#xD;
             jejunum around the ligament of Treitz&#xD;
&#xD;
          -  Large volume ascites&#xD;
&#xD;
          -  Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability,&#xD;
             severe pulmonary disease or other severe comorbidities&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Uncorrectable coagulopathy defined by INR &gt; 1.5 or platelet &lt; 50000/µl&#xD;
&#xD;
          -  Complete GOO evidenced by inability to either pass a wire across the stricture and/or&#xD;
             inability to opacify small bowel distal to the malignant stricture&#xD;
&#xD;
          -  Resectable or borderline resectable tumors&#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>Mouen A. Khashab, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mouen A. Khashab, MD</last_name>
    <phone>443-509-3388</phone>
    <email>mkhasha1@jhmi.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omid Sanaei, MD</last_name>
    <phone>410-502-0064</phone>
    <email>osanaei1@jhmi.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Bejjani, MD</last_name>
      <phone>443-743-5621</phone>
      <email>mbejjan1@jhmi.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Rio Hortega</name>
      <address>
        <city>Valladolid</city>
        <zip>47012</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Francisco Javier Garcia-Alonso</last_name>
      <phone>680351234</phone>
      <phone_ext>0034</phone_ext>
      <email>mailto:fj.garcia.alonso@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sergio Bazaga</last_name>
      <phone>627995214</phone>
      <email>mailto:Email%3ASergio.bpr@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mittal A, Windsor J, Woodfield J, Casey P, Lane M. Matched study of three methods for palliation of malignant pyloroduodenal obstruction. Br J Surg. 2004 Feb;91(2):205-9. doi: 10.1002/bjs.4396.</citation>
    <PMID>14760669</PMID>
  </reference>
  <reference>
    <citation>Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3.</citation>
    <PMID>15457364</PMID>
  </reference>
  <reference>
    <citation>Maetani I, Akatsuka S, Ikeda M, Tada T, Ukita T, Nakamura Y, Nagao J, Sakai Y. Self-expandable metallic stent placement for palliation in gastric outlet obstructions caused by gastric cancer: a comparison with surgical gastrojejunostomy. J Gastroenterol. 2005 Oct;40(10):932-7. doi: 10.1007/s00535-005-1651-7.</citation>
    <PMID>16261429</PMID>
  </reference>
  <reference>
    <citation>Khashab M, Alawad AS, Shin EJ, Kim K, Bourdel N, Singh VK, Lennon AM, Hutfless S, Sharaiha RZ, Amateau S, Okolo PI, Makary MA, Wolfgang C, Canto MI, Kalloo AN. Enteral stenting versus gastrojejunostomy for palliation of malignant gastric outlet obstruction. Surg Endosc. 2013 Jun;27(6):2068-75. doi: 10.1007/s00464-012-2712-7. Epub 2013 Jan 9.</citation>
    <PMID>23299137</PMID>
  </reference>
  <reference>
    <citation>Khashab MA, Kumbhari V, Grimm IS, Ngamruengphong S, Aguila G, El Zein M, Kalloo AN, Baron TH. EUS-guided gastroenterostomy: the first U.S. clinical experience (with video). Gastrointest Endosc. 2015 Nov;82(5):932-8. doi: 10.1016/j.gie.2015.06.017. Epub 2015 Jul 26.</citation>
    <PMID>26215646</PMID>
  </reference>
  <reference>
    <citation>Itoi T, Baron TH, Khashab MA, Tsuchiya T, Irani S, Dhir V, Bun Teoh AY. Technical review of endoscopic ultrasonography-guided gastroenterostomy in 2017. Dig Endosc. 2017 May;29(4):495-502. doi: 10.1111/den.12794. Epub 2017 Jan 27.</citation>
    <PMID>28032663</PMID>
  </reference>
  <reference>
    <citation>Chen YI, Itoi T, Baron TH, Nieto J, Haito-Chavez Y, Grimm IS, Ismail A, Ngamruengphong S, Bukhari M, Hajiyeva G, Alawad AS, Kumbhari V, Khashab MA. EUS-guided gastroenterostomy is comparable to enteral stenting with fewer re-interventions in malignant gastric outlet obstruction. Surg Endosc. 2017 Jul;31(7):2946-2952. doi: 10.1007/s00464-016-5311-1. Epub 2016 Nov 10. Erratum In: Surg Endosc. 2017 Jul 17;:</citation>
    <PMID>27834024</PMID>
  </reference>
  <reference>
    <citation>Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.</citation>
    <PMID>20189503</PMID>
  </reference>
  <reference>
    <citation>Adler DG, Baron TH. Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients. Am J Gastroenterol. 2002 Jan;97(1):72-8. doi: 10.1111/j.1572-0241.2002.05423.x.</citation>
    <PMID>11808972</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastroenterostomy</keyword>
  <keyword>Gastric Outlet Obstruction</keyword>
  <keyword>Cancer</keyword>
  <keyword>Endosonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastric Outlet Obstruction</mesh_term>
    <mesh_term>Pyloric Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03259763
org study id: IRB00128878
nct id: NCT03259763
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is
      associated with substantial morbidity. Palliation of GOO has traditionally been through the
      surgical bypass of the obstructed lumen by creating an opening between the stomach and small
      intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has
      gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this
      study, the investigators are going to compare the safety and efficacy of the two different
      endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE)
      and enteral stenting (ES).
In recent years, Enteral Stenting (ES) has commonly been used as the first line management of
      unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic
      ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique
      for palliation of malignant GOO, which has the theoretical potential to minimize the risk for
      stent occlusion while maintaining the less invasive endoscopic approach. This novel
      endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby
      bypassing the occluded lumen. This endoscopic technique has been performed to treat patients
      with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable
      to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly
      decreased risk of recurrent GOO and reinterventions.

      Based on the investigator's clinical experience for the last three years and the
      above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with
      ES in the management of unresectable malignant gastric outlet obstruction. The investigators
      hypothesize that EUS-GE is associated with comparable technical and clinical success and
      safety profile while requiring fewer re-interventions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomly allocated with a 1:1 ratio to one of the study arms (EUS-GE or ES)
primary purpose: Treatment
masking: Single (Participant)
measure: Rate of gastric outlet obstruction recurrence
time frame: 3 months
description: Recurrence of nausea, vomiting, and inability to tolerate PO intake up to 3 months after the procedure confirmed either endoscopically and/or radiographically.
measure: Technical success rate
time frame: Day of procedure
description: Adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.
measure: Clinical success rate
time frame: 1 week
description: The improvement of at least 1 point in the gastric outlet obstruction score within 7 days after stent insertion.
measure: Length of procedure
time frame: Day of procedure
measure: Adverse events rate
time frame: 1 week
measure: Post-procedure length of hospital stay
time frame: 1 week
measure: Reintervention rate for recurrent gastric outlet obstruction
time frame: 3 months
measure: Quality of Life SF-36 questionnaire scoring
time frame: 3 months
description: The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.
measure: Overall survival rate
time frame: 1 year
measure: Time to recurrent gastric outlet obstruction
time frame: 3 months
measure: Gastric Outlet Obstruction Scoring system (GOOSS)
time frame: 1 year
description: Diet toleration will be scored based on the Gastric Outlet Obstruction Scoring System (GOOSS). The scoring ranges from 0 to 3 in the following format:
0 = no oral intake, 1 = liquids only, 2 = soft solids, 3 = low-residue or full diet
measure: Stent Dysfunction Rate
time frame: 3 months
description: the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture
measure: Duration of stent patency
time frame: 3 months
description: Calculated from the time of stent placement to the time of stent dysfunction
arm group label: EUS-guided gastroenterostomy (EUS-GE)
arm group type: Active Comparator
description: In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.
arm group label: Enteral Stenting (ES)
arm group type: Active Comparator
description: In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.
intervention type: Device
intervention name: Lumen-apposing metal stent
description: In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.
arm group label: EUS-guided gastroenterostomy (EUS-GE)
intervention type: Device
intervention name: Self-expandable metal stent
description: In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.
arm group label: Enteral Stenting (ES)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mouen A. Khashab, MD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Mouen A. Khashab, MD
phone: 443-509-3388
email: mkhasha1@jhmi.edu
last name: Omid Sanaei, MD
phone: 410-502-0064
email: osanaei1@jhmi.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
country: Spain
country: United States
citation: Mittal A, Windsor J, Woodfield J, Casey P, Lane M. Matched study of three methods for palliation of malignant pyloroduodenal obstruction. Br J Surg. 2004 Feb;91(2):205-9. doi: 10.1002/bjs.4396.
PMID: 14760669
citation: Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3.
PMID: 15457364
citation: Maetani I, Akatsuka S, Ikeda M, Tada T, Ukita T, Nakamura Y, Nagao J, Sakai Y. Self-expandable metallic stent placement for palliation in gastric outlet obstructions caused by gastric cancer: a comparison with surgical gastrojejunostomy. J Gastroenterol. 2005 Oct;40(10):932-7. doi: 10.1007/s00535-005-1651-7.
PMID: 16261429
citation: Khashab M, Alawad AS, Shin EJ, Kim K, Bourdel N, Singh VK, Lennon AM, Hutfless S, Sharaiha RZ, Amateau S, Okolo PI, Makary MA, Wolfgang C, Canto MI, Kalloo AN. Enteral stenting versus gastrojejunostomy for palliation of malignant gastric outlet obstruction. Surg Endosc. 2013 Jun;27(6):2068-75. doi: 10.1007/s00464-012-2712-7. Epub 2013 Jan 9.
PMID: 23299137
citation: Khashab MA, Kumbhari V, Grimm IS, Ngamruengphong S, Aguila G, El Zein M, Kalloo AN, Baron TH. EUS-guided gastroenterostomy: the first U.S. clinical experience (with video). Gastrointest Endosc. 2015 Nov;82(5):932-8. doi: 10.1016/j.gie.2015.06.017. Epub 2015 Jul 26.
PMID: 26215646
citation: Itoi T, Baron TH, Khashab MA, Tsuchiya T, Irani S, Dhir V, Bun Teoh AY. Technical review of endoscopic ultrasonography-guided gastroenterostomy in 2017. Dig Endosc. 2017 May;29(4):495-502. doi: 10.1111/den.12794. Epub 2017 Jan 27.
PMID: 28032663
citation: Chen YI, Itoi T, Baron TH, Nieto J, Haito-Chavez Y, Grimm IS, Ismail A, Ngamruengphong S, Bukhari M, Hajiyeva G, Alawad AS, Kumbhari V, Khashab MA. EUS-guided gastroenterostomy is comparable to enteral stenting with fewer re-interventions in malignant gastric outlet obstruction. Surg Endosc. 2017 Jul;31(7):2946-2952. doi: 10.1007/s00464-016-5311-1. Epub 2016 Nov 10. Erratum In: Surg Endosc. 2017 Jul 17;:
PMID: 27834024
citation: Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PMID: 20189503
citation: Adler DG, Baron TH. Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients. Am J Gastroenterol. 2002 Jan;97(1):72-8. doi: 10.1111/j.1572-0241.2002.05423.x.
PMID: 11808972
responsible party type: Sponsor
mesh term: Gastric Outlet Obstruction
mesh term: Pyloric Stenosis
sharing ipd: No