<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/NCT03823690</url>
  </required_header>
  <id_info>
    <org_study_id>CRE-2018.335</org_study_id>
    <nct_id>NCT03823690</nct_id>
  </id_info>
  <brief_title>EPASS Versus Uncovered Duodenal Stent for Unresectable Malignant Gastric Outlet Obstruction.</brief_title>
  <official_title>EUS-guided Balloon-occluded Gastrojejunostomy Bypass (EPASS) Versus Uncovered Duodenal Stent for Unresectable Malignant Gastric Outlet Obstruction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      Surgical gastrojejunostomy is the conventional treatment for palliating patients suffering&#xD;
      from of inoperable malignant gastric outlet obstruction (GOO). Although, the procedure is&#xD;
      associated with a high success and low re-intervention rates, there is a risk of morbidities&#xD;
      (10% - 16%) and mortalities (7%). The placement of a pyloro-duodenal self-expandable metallic&#xD;
      stent (SEMS) is an alternative to surgery for the palliating these patients. As compared to&#xD;
      surgery, the procedure is associated with shorter hospital stay, reduced morbidities and&#xD;
      cost. However, the clinical efficacy of SEMS is limited by several problems. In uncovered&#xD;
      SEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis.&#xD;
      In covered SEMS, stent migration occurs at a frequency of 14-25% and it is a major obstacle&#xD;
      to stent patency. As a result, randomized trials comparing uncovered stents and partially or&#xD;
      fully covered stents in patients with malignant GOO have reported comparable stent patency&#xD;
      between the two types of stents.&#xD;
&#xD;
      Recently, the creation of a gastrojejunostomy under EUS (EUS-GJ) guidance using&#xD;
      lumen-apposing stents has been described. The procedure was associated with a technical&#xD;
      success rate of around 90% and clinical success of 85% to 100%. The procedure holds the&#xD;
      potential to create a gastrojejunostomy without surgery. Furthermore, there is a low risk of&#xD;
      tumor ingrowth and stent migration, thus improving the stent patency and reducing the need of&#xD;
      re-intervention. We have previously published a novel method of creating EUS-GJ with the use&#xD;
      of a double balloon occluder (EPASS). The device provides a stable condition for performance&#xD;
      of EUS-GJ and improves the safety of the procedure. However, there is limited data on how&#xD;
      EPASS compares to endoscopic stenting. The aim of the current study is thus to compare EPASS&#xD;
      and DS under a randomized setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, SEMSs have provided an attractive alternative to surgery for palliation of&#xD;
      malignant gastric outlet obstruction. Several studies have assessed the clinical and&#xD;
      technical success rates of pyloro-duodenal SEMS for malignant gastroduodenal obstruction.&#xD;
      Technical success rates of 90% to 100% and clinical success of 80% to 95% was achieved.The&#xD;
      procedure was associated with quicker recovery and reduced morbidities as compared to&#xD;
      surgical gastrojeunostomies. However, the long-term patency of uncovered SEMS is limited by&#xD;
      the risk of tumor ingrowth that would lead to subsequent re-stenosis of the stents requiring&#xD;
      re-intervention. Thus to palliate malignant gastric outlet obstruction, surgical&#xD;
      gastrojejunostomy is preferred in patients that are at good risk for surgery with prolonged&#xD;
      life expectancy whilst insertion of pyloro-duodenal SEMS is preferred in patients that are&#xD;
      associated with high-risk for surgery and short life expectancy.&#xD;
&#xD;
      In lieu of the above reasons, it would be the ideal situation if a gastrojejunostomy could be&#xD;
      created endoscopically without surgery. The procedure could potentially avoid the risk of&#xD;
      morbidities and mortalities associated with surgery whilst enjoying the superior patency&#xD;
      associated with a gastrojejunostomy. However, a number of hurdles need to be overcome for&#xD;
      safe creation of an anastomosis endoscopically. Firstly, the collapsed bowel (duodenum or&#xD;
      jejunum) needs to be easily identified from the stomach. Secondly, a reliable method of&#xD;
      creating an anastomosis needs to be available. Lastly, a device for maintaining the&#xD;
      anastomosis between two non-adherent organs is required.&#xD;
&#xD;
      The use of EUS as a platform to create a gastrojejunostomy endoscopically may theoretically&#xD;
      tackle all of the above hurdles. The device could be used in the stomach to visualize the&#xD;
      adjacent duodenum or jejunum for anastomosis. A 19-gauge needle could be used to puncture the&#xD;
      adjacent bowel for passage of a guide-wire to connect the two non-adherent organs.&#xD;
      Thereafter, a SEMS could be placed between the two organs for creation and maintenance of the&#xD;
      anastomosis.&#xD;
&#xD;
      Initial results of EUS-guided gastrojejunostomies from two studies have become available.&#xD;
      Khashab et al reported EUS-GJ in 10 patients. Technical success was achieved in 9 patients&#xD;
      (90%). Clinical success with resumption of solid oral intake was achieved in all 9 patients&#xD;
      (100%), who underwent successful EUS-GE. 8 patients were able to tolerate almost a normal&#xD;
      diet and/or full diet, and 1 patient tolerated a soft diet. There were no procedure-related&#xD;
      adverse events. Mean procedure time was 96 minutes (range 45-152 minutes), and mean length of&#xD;
      hospital stay was 2.2 days. In another multicenter study, 26 patients received EUS-GJ.&#xD;
      Technical success was achieved in 24 patients (92 %). Clinical success was achieved in 22&#xD;
      patients (85 %). Of the 4 patients in whom clinical success was not achieved, 2 had&#xD;
      persistent nausea and vomiting despite a patent EUS-GJ and required enteral feeding for&#xD;
      nutrition, 1 died before the initiation of an oral diet, and 1 underwent surgery for&#xD;
      suspected perforation. Adverse events, including peritonitis, bleeding, and surgery, occurred&#xD;
      in 3 patients (11.5 %). In both of these studies, the AXIOS stent was used for creation of&#xD;
      the anastomosis (Boston Scientific, Natick, MA, USA).&#xD;
&#xD;
      However, a common technical problem exists in both of these series. The target duodenum or&#xD;
      jejunum needed for creation of a GJ is collapsed and it is difficult to identify the target&#xD;
      organ by EUS from the stomach. Furthermore, the insertion of the stent for creation of the&#xD;
      anastomosis may be difficult with a collapsed bowel and this may result in catastrophic&#xD;
      outcomes. Our group has overcome this problem with a novel device - the double balloon&#xD;
      occluder. The device comprises of two balloons that could occlude a segment of bowel. Saline&#xD;
      could then be injected in to the occluded segment resulting in distension of the bowel and&#xD;
      making it possible to be targeted by EUS from the stomach.&#xD;
&#xD;
      Our group has published the results of using the double balloon occluder in conjunction with&#xD;
      the AXIOS stent for creation of a GJ in 20 patients (Endoscopic ultrasonography-guided&#xD;
      double-balloon-occluded gastrojejunostomy bypass - EPASS). The technical success rate was 90%&#xD;
      (18/20). The median intubation time from the double-balloon tube intubation to stent&#xD;
      placement was 25.5 min (range 10-39 min). Post-treatment gastric outlet obstruction scoring&#xD;
      system (GOOSS) score improved in all 18 cases in which EPASS was successfully performed. The&#xD;
      mean post-GOOSS score was significantly higher than the pre-GOOSS score (0.6±0.75 vs&#xD;
      2.94±0.23, p&lt;0.001). None of the patients with successful placement of the stent suffered&#xD;
      from adverse events or recurrent obstruction.&#xD;
&#xD;
      The outcomes of EUS-GJ were recently compared with that of conventional procedures for&#xD;
      management of malignant GOO. In a retrospective study, EUS-GJ was compared with DS. 30&#xD;
      patients received EUS-GJ and 60 patients DS. The technical success rates were similar between&#xD;
      the two groups (96.7% vs. 86.7%, P=0.07). Clinical success was also similar between the two&#xD;
      groups (70.0% vs. 86.7%, P=0.08). The re-intervention rate was significantly higher in the ES&#xD;
      group (43.3% vs. 3.4%, P&lt;0.001), whilst adverse events were comparable (13.3% vs 18.3%, P =&#xD;
      0.549). On multivariate analysis, DS was independently associated with need for&#xD;
      re-intervention (OR 25.7, p=0.004). In another study, EUS-GJ (25 patients) was compared with&#xD;
      laparoscopic gastrojejunostomy (29 patients) 20. Technical success was comparable (88% vs&#xD;
      100%, P = 0.11). Clinical success was similar (84% vs 90%, P = 0.11). Average post-procedure&#xD;
      length of stay was 9.4 days in the EUS-GJ group and 8.9 days in the Lap-GJ group (P = 0.75).&#xD;
      Adverse events were significantly more the lap-GJ group (41% vs 12%, P = 0.03).&#xD;
&#xD;
      Thus, based on the above results, EUS-GJ may be associated with improved outcomes as compared&#xD;
      with conventional procedures for management of malignant GOO. Hence, the aim of the current&#xD;
      study is to compare the efficacies of EPASS versus uncovered pyloro-duodenal stents (DS) in&#xD;
      unresectable malignant gastric outlet obstruction in a randomized setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">May 30, 2022</completion_date>
  <primary_completion_date type="Actual">May 30, 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>The patients would be randomized to either EUS-guided balloon-occluded gastrojejunostomy bypass (EPASS) or uncovered duodenal stent after cannulation of the obstruction site is achieved with the guide-wire.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Recruited patients would not be informed of the type of treatment that was received.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Re-intervention rate</measure>
    <time_frame>6 months</time_frame>
    <description>The percentage of patients requiring additional endoscopic intervention due to stent dysfunction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success rate</measure>
    <time_frame>1 day</time_frame>
    <description>The successful placement of a stent across the site of obstruction, as confirmed by endoscopy or fluoroscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success rate</measure>
    <time_frame>3 days</time_frame>
    <description>Clinical success if measured by the improvement of at least 1 point in the gastric outlet obstruction score within 3 days after stent insertion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent dysfunction rate</measure>
    <time_frame>6 months</time_frame>
    <description>Stent dysfunction is defined as 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>6 months</time_frame>
    <description>Calculated from the time of stent placement to the time of stent dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events rate</measure>
    <time_frame>6 months</time_frame>
    <description>Graded according to the lexicon of endoscopic adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>6 months</time_frame>
    <description>Death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric outlet obstruction scores (GOOS)</measure>
    <time_frame>6 months</time_frame>
    <description>Scoring system for food intake. Range of score is 0 -3 with 3 being the highest and indicating tolerating full diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment scores</measure>
    <time_frame>6 months</time_frame>
    <description>EORTC QLQ-C30. This questionnaire is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of 5 multiitem scales (physical, role, social, emotional and cognitive functioning) and 9 single items (pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment scores</measure>
    <time_frame>6 months</time_frame>
    <description>EORTC STO-22 modules. This the gastric cancer module to the QLQ-C30 questionnaire. The questionnaire is composed of 5 multiitem scales (dysphagia, pain, reflux, eating, anxiety) and 4 single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Gastric Outlet Obstruction</condition>
  <arm_group>
    <arm_group_label>EUS-guided gastrojejunostomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The procedures would be performed under conscious sedation or monitored anesthesia by a therapeutic gastroscope. The endoscope would be used to reach the site of obstruction. The stricture would be cannulated with a 0.025&quot; or 0.035&quot; guide-wire. The double balloon occluder would then be inserted on guidewire beyond the duodenal-jejunal flexure and the two balloons of the occluder would be inflated.&#xD;
A segment of duodenum/jejunum would then be occluded and saline would be injected. A linear echoendoscope would then be inserted into the stomach to guide insertion of the gastrojejunostomy stent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pyloro-duodenal stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The uncovered DS used in this study is Wallflex (Boston, Natick, MA, USA), made of nitinol wire, with a diameter of 22mm and length of 6, 9, 12cm. This stent is a braided stent with high axial force, good flexibility and conformability.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EUS-guided gastrojejunstomy</intervention_name>
    <description>As listed in the arms description</description>
    <arm_group_label>EUS-guided gastrojejunostomy</arm_group_label>
    <other_name>EPASS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The pyloro-duodenal stent</intervention_name>
    <description>As listed in the arms description</description>
    <arm_group_label>Pyloro-duodenal stent</arm_group_label>
    <other_name>DS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients ≥ 18 years old&#xD;
&#xD;
          -  Confirmed unresectable distal gastric or duodenal or pancreatico-biliary malignancies&#xD;
&#xD;
          -  Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤&#xD;
             1&#xD;
&#xD;
          -  Performance status ECOG ≤3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior metallic stent placement&#xD;
&#xD;
          -  Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary&#xD;
             disease, sepsis, or a bleeding disorder)&#xD;
&#xD;
          -  Life expectancy of less than 1 month&#xD;
&#xD;
          -  History of gastric surgery&#xD;
&#xD;
          -  Linitus plastic&#xD;
&#xD;
          -  Multiple-level bowel obstruction confirmed on radiographic studies such as small bowel&#xD;
             series or abdominal computed tomography&#xD;
&#xD;
          -  Coagulation disorders&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Surgery, Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Anthony Teoh</investigator_full_name>
    <investigator_title>Honorary Associate Professor</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT03823690
org study id: CRE-2018.335
nct id: NCT03823690
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Surgical gastrojejunostomy is the conventional treatment for palliating patients suffering
      from of inoperable malignant gastric outlet obstruction (GOO). Although, the procedure is
      associated with a high success and low re-intervention rates, there is a risk of morbidities
      (10% - 16%) and mortalities (7%). The placement of a pyloro-duodenal self-expandable metallic
      stent (SEMS) is an alternative to surgery for the palliating these patients. As compared to
      surgery, the procedure is associated with shorter hospital stay, reduced morbidities and
      cost. However, the clinical efficacy of SEMS is limited by several problems. In uncovered
      SEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis.
      In covered SEMS, stent migration occurs at a frequency of 14-25% and it is a major obstacle
      to stent patency. As a result, randomized trials comparing uncovered stents and partially or
      fully covered stents in patients with malignant GOO have reported comparable stent patency
      between the two types of stents.

      Recently, the creation of a gastrojejunostomy under EUS (EUS-GJ) guidance using
      lumen-apposing stents has been described. The procedure was associated with a technical
      success rate of around 90% and clinical success of 85% to 100%. The procedure holds the
      potential to create a gastrojejunostomy without surgery. Furthermore, there is a low risk of
      tumor ingrowth and stent migration, thus improving the stent patency and reducing the need of
      re-intervention. We have previously published a novel method of creating EUS-GJ with the use
      of a double balloon occluder (EPASS). The device provides a stable condition for performance
      of EUS-GJ and improves the safety of the procedure. However, there is limited data on how
      EPASS compares to endoscopic stenting. The aim of the current study is thus to compare EPASS
      and DS under a randomized setting.
In recent years, SEMSs have provided an attractive alternative to surgery for palliation of
      malignant gastric outlet obstruction. Several studies have assessed the clinical and
      technical success rates of pyloro-duodenal SEMS for malignant gastroduodenal obstruction.
      Technical success rates of 90% to 100% and clinical success of 80% to 95% was achieved.The
      procedure was associated with quicker recovery and reduced morbidities as compared to
      surgical gastrojeunostomies. However, the long-term patency of uncovered SEMS is limited by
      the risk of tumor ingrowth that would lead to subsequent re-stenosis of the stents requiring
      re-intervention. Thus to palliate malignant gastric outlet obstruction, surgical
      gastrojejunostomy is preferred in patients that are at good risk for surgery with prolonged
      life expectancy whilst insertion of pyloro-duodenal SEMS is preferred in patients that are
      associated with high-risk for surgery and short life expectancy.

      In lieu of the above reasons, it would be the ideal situation if a gastrojejunostomy could be
      created endoscopically without surgery. The procedure could potentially avoid the risk of
      morbidities and mortalities associated with surgery whilst enjoying the superior patency
      associated with a gastrojejunostomy. However, a number of hurdles need to be overcome for
      safe creation of an anastomosis endoscopically. Firstly, the collapsed bowel (duodenum or
      jejunum) needs to be easily identified from the stomach. Secondly, a reliable method of
      creating an anastomosis needs to be available. Lastly, a device for maintaining the
      anastomosis between two non-adherent organs is required.

      The use of EUS as a platform to create a gastrojejunostomy endoscopically may theoretically
      tackle all of the above hurdles. The device could be used in the stomach to visualize the
      adjacent duodenum or jejunum for anastomosis. A 19-gauge needle could be used to puncture the
      adjacent bowel for passage of a guide-wire to connect the two non-adherent organs.
      Thereafter, a SEMS could be placed between the two organs for creation and maintenance of the
      anastomosis.

      Initial results of EUS-guided gastrojejunostomies from two studies have become available.
      Khashab et al reported EUS-GJ in 10 patients. Technical success was achieved in 9 patients
      (90%). Clinical success with resumption of solid oral intake was achieved in all 9 patients
      (100%), who underwent successful EUS-GE. 8 patients were able to tolerate almost a normal
      diet and/or full diet, and 1 patient tolerated a soft diet. There were no procedure-related
      adverse events. Mean procedure time was 96 minutes (range 45-152 minutes), and mean length of
      hospital stay was 2.2 days. In another multicenter study, 26 patients received EUS-GJ.
      Technical success was achieved in 24 patients (92 %). Clinical success was achieved in 22
      patients (85 %). Of the 4 patients in whom clinical success was not achieved, 2 had
      persistent nausea and vomiting despite a patent EUS-GJ and required enteral feeding for
      nutrition, 1 died before the initiation of an oral diet, and 1 underwent surgery for
      suspected perforation. Adverse events, including peritonitis, bleeding, and surgery, occurred
      in 3 patients (11.5 %). In both of these studies, the AXIOS stent was used for creation of
      the anastomosis (Boston Scientific, Natick, MA, USA).

      However, a common technical problem exists in both of these series. The target duodenum or
      jejunum needed for creation of a GJ is collapsed and it is difficult to identify the target
      organ by EUS from the stomach. Furthermore, the insertion of the stent for creation of the
      anastomosis may be difficult with a collapsed bowel and this may result in catastrophic
      outcomes. Our group has overcome this problem with a novel device - the double balloon
      occluder. The device comprises of two balloons that could occlude a segment of bowel. Saline
      could then be injected in to the occluded segment resulting in distension of the bowel and
      making it possible to be targeted by EUS from the stomach.

      Our group has published the results of using the double balloon occluder in conjunction with
      the AXIOS stent for creation of a GJ in 20 patients (Endoscopic ultrasonography-guided
      double-balloon-occluded gastrojejunostomy bypass - EPASS). The technical success rate was 90%
      (18/20). The median intubation time from the double-balloon tube intubation to stent
      placement was 25.5 min (range 10-39 min). Post-treatment gastric outlet obstruction scoring
      system (GOOSS) score improved in all 18 cases in which EPASS was successfully performed. The
      mean post-GOOSS score was significantly higher than the pre-GOOSS score (0.6±0.75 vs
      2.94±0.23, p<0.001). None of the patients with successful placement of the stent suffered
      from adverse events or recurrent obstruction.

      The outcomes of EUS-GJ were recently compared with that of conventional procedures for
      management of malignant GOO. In a retrospective study, EUS-GJ was compared with DS. 30
      patients received EUS-GJ and 60 patients DS. The technical success rates were similar between
      the two groups (96.7% vs. 86.7%, P=0.07). Clinical success was also similar between the two
      groups (70.0% vs. 86.7%, P=0.08). The re-intervention rate was significantly higher in the ES
      group (43.3% vs. 3.4%, P<0.001), whilst adverse events were comparable (13.3% vs 18.3%, P =
      0.549). On multivariate analysis, DS was independently associated with need for
      re-intervention (OR 25.7, p=0.004). In another study, EUS-GJ (25 patients) was compared with
      laparoscopic gastrojejunostomy (29 patients) 20. Technical success was comparable (88% vs
      100%, P = 0.11). Clinical success was similar (84% vs 90%, P = 0.11). Average post-procedure
      length of stay was 9.4 days in the EUS-GJ group and 8.9 days in the Lap-GJ group (P = 0.75).
      Adverse events were significantly more the lap-GJ group (41% vs 12%, P = 0.03).

      Thus, based on the above results, EUS-GJ may be associated with improved outcomes as compared
      with conventional procedures for management of malignant GOO. Hence, the aim of the current
      study is to compare the efficacies of EPASS versus uncovered pyloro-duodenal stents (DS) in
      unresectable malignant gastric outlet obstruction in a randomized setting.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The patients would be randomized to either EUS-guided balloon-occluded gastrojejunostomy bypass (EPASS) or uncovered duodenal stent after cannulation of the obstruction site is achieved with the guide-wire.
primary purpose: Treatment
masking: Single (Participant)
masking description: Recruited patients would not be informed of the type of treatment that was received.
measure: Re-intervention rate
time frame: 6 months
description: The percentage of patients requiring additional endoscopic intervention due to stent dysfunction.
measure: Technical success rate
time frame: 1 day
description: The successful placement of a stent across the site of obstruction, as confirmed by endoscopy or fluoroscopy.
measure: Clinical success rate
time frame: 3 days
description: Clinical success if measured by the improvement of at least 1 point in the gastric outlet obstruction score within 3 days after stent insertion.
measure: Stent dysfunction rate
time frame: 6 months
description: Stent dysfunction is defined as the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture.
measure: Duration of stent patency
time frame: 6 months
description: Calculated from the time of stent placement to the time of stent dysfunction.
measure: Adverse events rate
time frame: 6 months
description: Graded according to the lexicon of endoscopic adverse events
measure: Mortality
time frame: 6 months
description: Death from any cause
measure: Gastric outlet obstruction scores (GOOS)
time frame: 6 months
description: Scoring system for food intake. Range of score is 0 -3 with 3 being the highest and indicating tolerating full diet
measure: Quality of life assessment scores
time frame: 6 months
description: EORTC QLQ-C30. This questionnaire is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of 5 multiitem scales (physical, role, social, emotional and cognitive functioning) and 9 single items (pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
measure: Quality of life assessment scores
time frame: 6 months
description: EORTC STO-22 modules. This the gastric cancer module to the QLQ-C30 questionnaire. The questionnaire is composed of 5 multiitem scales (dysphagia, pain, reflux, eating, anxiety) and 4 single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
arm group label: EUS-guided gastrojejunostomy
arm group type: Active Comparator
description: The procedures would be performed under conscious sedation or monitored anesthesia by a therapeutic gastroscope. The endoscope would be used to reach the site of obstruction. The stricture would be cannulated with a 0.025" or 0.035" guide-wire. The double balloon occluder would then be inserted on guidewire beyond the duodenal-jejunal flexure and the two balloons of the occluder would be inflated.
A segment of duodenum/jejunum would then be occluded and saline would be injected. A linear echoendoscope would then be inserted into the stomach to guide insertion of the gastrojejunostomy stent.
arm group label: Pyloro-duodenal stent
arm group type: Active Comparator
description: The uncovered DS used in this study is Wallflex (Boston, Natick, MA, USA), made of nitinol wire, with a diameter of 22mm and length of 6, 9, 12cm. This stent is a braided stent with high axial force, good flexibility and conformability.
intervention type: Device
intervention name: EUS-guided gastrojejunstomy
description: As listed in the arms description
arm group label: EUS-guided gastrojejunostomy
other name: EPASS
intervention type: Device
intervention name: The pyloro-duodenal stent
description: As listed in the arms description
arm group label: Pyloro-duodenal stent
other name: DS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Anthony Teoh
investigator title: Honorary Associate Professor
mesh term: Gastric Outlet Obstruction
mesh term: Pyloric Stenosis