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Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02784470
Recruitment Status : Unknown
Verified May 2016 by Moon-Won Yoo, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Information provided by (Responsible Party):
Moon-Won Yoo, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE May 19, 2016
First Posted Date  ICMJE May 27, 2016
Last Update Posted Date May 27, 2016
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
Gastric Outlet Obstruction Scoring System (GOOSS) score [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy
Official Title  ICMJE Not Provided
Brief Summary Selection of the optimal treatment for gastric outlet obstruction in patients with radically unresectable gastric cancer remains controversial because previous studies comparing the two procedures had a small sample size as well as they included various etiologies such as gastrointestinal (GI) cancer, duodenal cancer and pancreaticobiliary cancer in selecting the patient population. Therefore, to establish the standard of care for patients with radically unresectable gastric cancer with gastric outlet obstruction, a larger prospective, randomized, controlled clinical trial using a single type of stent is warranted.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Device: gastroduodenal stent placement
  • Procedure: gastrojejunostomy
Study Arms  ICMJE
  • Experimental: gastrojejunostomy arm
    Intervention: Procedure: gastrojejunostomy
  • Active Comparator: gastroduodenal stent placement
    Intervention: Device: gastroduodenal stent placement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 24, 2016)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged ≥19 to 80 years
  • ECOG performance status 0-3
  • Life expectancy >3 months
  • Patients with malignant gastric outlet obstruction (distal part of stomach, pyloric ring or duodenal bulb obstruction) caused by gastric cancer
  • Patients who are not eligible for radical operation due to local progression of gastric cancer, distant metastasis or his/her general condition.
  • Patients with GOOSS score 0-2
  • Patients with symptoms consistent with gastric outlet obstruction including persistent nausea and vomiting
  • Patients with findings consistent with malignant gastric outlet obstruction on imaging studies including upper GI endoscopy, upper GIseries or abdominal computed tomography (CT)
  • Patients who are eligible to undergo both gastroduodenal stent placement and gastrojejunostomy (eligibility will be determined by agreement by at least one gastroenterological surgeon and at least one radiologist)
  • Patients who have been provided with an explanation of the procedures of the clinical trial, voluntarily decided participation and signed the informed consent form

Exclusion Criteria:

  • Pregnant or lactating women
  • Women of childbearing potential with positive pregnancy test at baseline. Post-menopausal women should have at least 12 months of amenorrhea to be considered not of childbearing potential.
  • Patients who have previously undergone balloon dilatation or stent placement for malignant gastric outlet obstruction
  • Patients with past history of palliative bypass surgery or gastrectomy
  • Patients with peritoneal metastasis or multiple intestinal obstruction caused by other cause on imaging scan including abdominal CT or small bowel series
  • Patients who have been treated for intestinal adhesion caused by previous abdominal surgery
  • Patients who are not eligible for general anesthesia due to poor general condition
  • Patients with clinical evidence of intestinal perforation or peritonitis
  • Patients who are determined to be not eligible for stent placement or gastrojejunostomy due to other cause
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02784470
Other Study ID Numbers  ICMJE 20151141
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Moon-Won Yoo, Asan Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Asan Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yoomoon Won, MD Asan Medical Center
PRS Account Asan Medical Center
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP