xml: <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/NCT05986890</url>
    </required_header>
    <id_info>
      <org_study_id>2022-433</org_study_id>
      <nct_id>NCT05986890</nct_id>
    </id_info>
    <brief_title>Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction</brief_title>
    <official_title>Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Spectrum Health Hospitals</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Spectrum Health Hospitals</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is intended to investigate whether roux-en-y bypass surgery is superior to&#xD;
        conventional loop gastrojejunostomy for Malignant gastric outlet obstruction in terms of&#xD;
        tolerance to solid food intake. We hypothesize that roux-en-y bypass will be associated with&#xD;
        improved solid food intake in the first 30 days after surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Malignant gastric outlet obstruction is when malignant tumor growth obstructs the gastric&#xD;
        outlet at the level of the distal stomach or duodenum, causing food intolerance with nausea&#xD;
        and vomiting. Most often, this signifies advanced neoplastic disease with associated poor&#xD;
        prognosis for patients. Restoring patients to oral intake is important for palliative&#xD;
        purposes. The current standard of care in patients requiring long-term alleviation of&#xD;
        symptoms (≥2 months) is performing a loop gastrojejunostomy. This involves creating an&#xD;
        intestinal bypass to the site of obstruction in the duodenum or distal stomach. This&#xD;
        procedure has long been criticized for its poor resultant function for patients, mainly due&#xD;
        to poor tolerance to food intake that include frequent episodes of nausea and vomiting and&#xD;
        inability to for solid food intake. The need for a durable solution to malignant gastric&#xD;
        outlet obstruction that provides better tolerance to solid food intake is evident. The&#xD;
        roux-en-y gastric bypass procedure has been performed for a variety of indications for&#xD;
        decades, most commonly for weight loss but also with oncologic resections of the stomach in&#xD;
        cases of gastric cancer. Laparoscopic roux-en-y gastric bypass (R-Y bypass) has become the&#xD;
        standard for this procedure in experienced hands and has been found to be safe in the short-&#xD;
        and long term. The long-term function after R-Y bypass is generally favorable across&#xD;
        published literature. No studies exist to compare loop gastrojejunostomy to roux-en-y gastric&#xD;
        bypass in patients with malignant gastric outlet obstruction.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.</measure>
      <time_frame>7 days post operative</time_frame>
      <description>Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Gastric emptying study at 30-days</measure>
      <time_frame>30 days post operative</time_frame>
      <description>Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient reported daily gastric outlet obstruction scoring system (GOOS) score</measure>
      <time_frame>30 days postoperative</time_frame>
      <description>Patients will score each day with the score that reflects the diet that was tolerated that day by the patient. This includes what was able to be ingested without a subsequent vomiting.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Clavien-Dindo grade ≥3 adverse event</measure>
      <time_frame>14 days postoperative</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients requiring reoperation for any indication</measure>
      <time_frame>30 days postoperative</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery</measure>
      <time_frame>30 days postoperative</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from surgery to death</measure>
      <time_frame>100 days postoperative</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of quality of life as measured by short form QOL Questionnaire</measure>
      <time_frame>measured pre-operatively, at 25-35 days post op and 80-100 days post op</time_frame>
      <description>The short form 36 question QOL questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of quality of life as measured GIQLI</measure>
      <time_frame>measured pre-operatively, at 25-35 days post op and 80-100 days post op</time_frame>
      <description>The Gastrointestinal quality of life questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Malignant Gastric Outlet Obstruction</condition>
    <arm_group>
      <arm_group_label>Roux-en-Y Bypass</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>laparoscopic Roux-en-Y (R-Y) procedure is a well-established procedure, commonly utilized in the setting of bariatric- and gastric cancer surgery. The procedure establishes intestinal continuity that bypasses the distal stomach and duodenum. This is achieved by dividing the jejunum 30-40 cm distal to the ligament of Treitz, bringing the distal end of jejunum up anterior to the transverse colon to be anastomosed to the back wall of the stomach (forming the Roux-limb). The proximal cut end of jejunum then gets anastomosed to the downstream roux-limb (forming the Y-limb). The benefits of this reconstruction include less chance of gastric contents travelling into the afferent limb and similarly, avoiding bile reflux from the afferent limb with associated bile gastritis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Gastrojejunostomy</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>surgical gastrojejunostomy, a procedure dating back to the late 1800's.5 This surgical bypass consists of connecting the stomach to a loop of proximal small bowel, thus bypassing any duodenal or distal gastric obstruction.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Roux-en-Y Bypass</intervention_name>
      <description>laparoscopic Roux-en-Y</description>
      <arm_group_label>Roux-en-Y Bypass</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>gastrojejunostomy</intervention_name>
      <description>surgical gastrojejunostomy</description>
      <arm_group_label>Gastrojejunostomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Provision of signed and dated informed consent form.&#xD;
  &#xD;
            2. Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study.&#xD;
  &#xD;
            3. Male or female aged ≥18 years old.&#xD;
  &#xD;
            4. Patients with a diagnosis of malignant gastric outlet obstruction. i. Defined as&#xD;
               malignant cancer growth of any organ origin in the area of the distal stomach or&#xD;
               duodenum preventing normal gastric emptying as determined by symptoms and&#xD;
               cross-sectional imaging studies.&#xD;
  &#xD;
               ii. Symptoms can include abdominal distention, abdominal pain, nausea and vomiting.&#xD;
  &#xD;
               iii. Cross sectional imaging findings can include tumor growth in the area of the&#xD;
               distal stomach or duodenum, gastric distention, fluid filled stomach and decompressed&#xD;
               bowel distal to obstruction point.&#xD;
  &#xD;
            5. Patients deemed to benefit from surgical bypass as opposed to stent placement, by the&#xD;
               primary surgeon. This includes assessing participants survival chances and ability to&#xD;
               undergo a surgical procedure.&#xD;
  &#xD;
            6. Patients in a general health status that permits abdominal surgery under general&#xD;
               anesthesia. As determined by primary surgeon and anesthesiologist.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients that have had previous treatment for malignant gastric outlet obstruction.&#xD;
  &#xD;
               a. Including any previous surgery or stent placement for MGOO&#xD;
  &#xD;
            2. Patients with MGOO deemed to benefit more from endoscopic stent placement rather than&#xD;
               surgery for symptom relief. This assessment will be at treating surgeon's discretion.&#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>G. Paul Wright, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Corewell Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>G. Paul Wright, MD</last_name>
      <phone>616-486-6333</phone>
      <email>paul.wright@corewellhealth.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Esther Peariso, MSN</last_name>
      <phone>6164860358</phone>
      <email>esther.peariso@corewellhealth.org</email>
    </overall_contact_backup>
    <reference>
      <citation>Weaver DW, Wiencek RG, Bouwman DL, Walt AJ. Gastrojejunostomy: is it helpful for patients with pancreatic cancer? Surgery. 1987 Oct;102(4):608-13.</citation>
      <PMID>2443991</PMID>
    </reference>
    <reference>
      <citation>Lillemoe KD, Cameron JL, Hardacre JM, Sohn TA, Sauter PK, Coleman J, Pitt HA, Yeo CJ. Is prophylactic gastrojejunostomy indicated for unresectable periampullary cancer? A prospective randomized trial. Ann Surg. 1999 Sep;230(3):322-8; discussion 328-30. doi: 10.1097/00000658-199909000-00005.</citation>
      <PMID>10493479</PMID>
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      <citation>Egrari S, O'Connell TX. Role of prophylactic gastroenterostomy for unresectable pancreatic carcinoma. Am Surg. 1995 Oct;61(10):862-4.</citation>
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      <citation>Del Piano M, Ballare M, Montino F, Todesco A, Orsello M, Magnani C, Garello E. Endoscopy or surgery for malignant GI outlet obstruction? Gastrointest Endosc. 2005 Mar;61(3):421-6. doi: 10.1016/s0016-5107(04)02757-9.</citation>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Spectrum Health Hospitals</investigator_affiliation>
      <investigator_full_name>Gerald P. Wright</investigator_full_name>
      <investigator_title>Surgical Oncology and Hepatopancreaticobiliary Surgeon</investigator_title>
    </responsible_party>
    <keyword>MGOO</keyword>
    <keyword>Malignant gastric outlet obstruction</keyword>
    <keyword>gastric outlet</keyword>
    <keyword>malignant tumor</keyword>
    <keyword>proximal bowel obstruction</keyword>
    <keyword>bowel obstruction</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>
  
  
text: 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/NCT05986890
  org study id: 2022-433
  nct id: NCT05986890
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is intended to investigate whether roux-en-y bypass surgery is superior to
        conventional loop gastrojejunostomy for Malignant gastric outlet obstruction in terms of
        tolerance to solid food intake. We hypothesize that roux-en-y bypass will be associated with
        improved solid food intake in the first 30 days after surgery.
  Malignant gastric outlet obstruction is when malignant tumor growth obstructs the gastric
        outlet at the level of the distal stomach or duodenum, causing food intolerance with nausea
        and vomiting. Most often, this signifies advanced neoplastic disease with associated poor
        prognosis for patients. Restoring patients to oral intake is important for palliative
        purposes. The current standard of care in patients requiring long-term alleviation of
        symptoms (≥2 months) is performing a loop gastrojejunostomy. This involves creating an
        intestinal bypass to the site of obstruction in the duodenum or distal stomach. This
        procedure has long been criticized for its poor resultant function for patients, mainly due
        to poor tolerance to food intake that include frequent episodes of nausea and vomiting and
        inability to for solid food intake. The need for a durable solution to malignant gastric
        outlet obstruction that provides better tolerance to solid food intake is evident. The
        roux-en-y gastric bypass procedure has been performed for a variety of indications for
        decades, most commonly for weight loss but also with oncologic resections of the stomach in
        cases of gastric cancer. Laparoscopic roux-en-y gastric bypass (R-Y bypass) has become the
        standard for this procedure in experienced hands and has been found to be safe in the short-
        and long term. The long-term function after R-Y bypass is generally favorable across
        published literature. No studies exist to compare loop gastrojejunostomy to roux-en-y gastric
        bypass in patients with malignant gastric outlet obstruction.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.
  time frame: 7 days post operative
  description: Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
  measure: Gastric emptying study at 30-days
  time frame: 30 days post operative
  description: Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
  measure: Patient reported daily gastric outlet obstruction scoring system (GOOS) score
  time frame: 30 days postoperative
  description: Patients will score each day with the score that reflects the diet that was tolerated that day by the patient. This includes what was able to be ingested without a subsequent vomiting.
  measure: Number of Clavien-Dindo grade ≥3 adverse event
  time frame: 14 days postoperative
  measure: Number of patients requiring reoperation for any indication
  time frame: 30 days postoperative
  measure: number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery
  time frame: 30 days postoperative
  measure: Time from surgery to death
  time frame: 100 days postoperative
  measure: Improvement of quality of life as measured by short form QOL Questionnaire
  time frame: measured pre-operatively, at 25-35 days post op and 80-100 days post op
  description: The short form 36 question QOL questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life
  measure: Improvement of quality of life as measured GIQLI
  time frame: measured pre-operatively, at 25-35 days post op and 80-100 days post op
  description: The Gastrointestinal quality of life questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life
  arm group label: Roux-en-Y Bypass
  arm group type: Other
  description: laparoscopic Roux-en-Y (R-Y) procedure is a well-established procedure, commonly utilized in the setting of bariatric- and gastric cancer surgery. The procedure establishes intestinal continuity that bypasses the distal stomach and duodenum. This is achieved by dividing the jejunum 30-40 cm distal to the ligament of Treitz, bringing the distal end of jejunum up anterior to the transverse colon to be anastomosed to the back wall of the stomach (forming the Roux-limb). The proximal cut end of jejunum then gets anastomosed to the downstream roux-limb (forming the Y-limb). The benefits of this reconstruction include less chance of gastric contents travelling into the afferent limb and similarly, avoiding bile reflux from the afferent limb with associated bile gastritis.
  arm group label: Gastrojejunostomy
  arm group type: Other
  description: surgical gastrojejunostomy, a procedure dating back to the late 1800's.5 This surgical bypass consists of connecting the stomach to a loop of proximal small bowel, thus bypassing any duodenal or distal gastric obstruction.
  intervention type: Procedure
  intervention name: Roux-en-Y Bypass
  description: laparoscopic Roux-en-Y
  arm group label: Roux-en-Y Bypass
  intervention type: Procedure
  intervention name: gastrojejunostomy
  description: surgical gastrojejunostomy
  arm group label: Gastrojejunostomy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: G. Paul Wright, MD
  role: Principal Investigator
  affiliation: Corewell Health
  last name: G. Paul Wright, MD
  phone: 616-486-6333
  email: paul.wright@corewellhealth.org
  last name: Esther Peariso, MSN
  phone: 6164860358
  email: esther.peariso@corewellhealth.org
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  PMID: 17063298
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  PMID: 17981197
  responsible party type: Principal Investigator
  investigator affiliation: Spectrum Health Hospitals
  investigator full name: Gerald P. Wright
  investigator title: Surgical Oncology and Hepatopancreaticobiliary Surgeon
  mesh term: Gastric Outlet Obstruction
  mesh term: Pyloric Stenosis
  sharing ipd: No