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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
Sponsor:
Information provided by (Responsible Party):
Moon-Won Yoo, Asan Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Device: gastroduodenal stent placement Procedure: gastrojejunostomy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: gastrojejunostomy arm Procedure: gastrojejunostomy
Active Comparator: gastroduodenal stent placement Device: gastroduodenal stent placement


Outcome Measures
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Primary Outcome Measures :
  1. Gastric Outlet Obstruction Scoring System (GOOSS) score [ Time Frame: Up to 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784470


Contacts
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Contact: Yoomoon Won, MD 82-2-3010-3484 medigang@hanmail.net

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Yoomoon Won, MD Asan Medical Center
More Information
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Responsible Party: Moon-Won Yoo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02784470    
Other Study ID Numbers: 20151141
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases