Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

• ClinicalTrials.gov Identifier: NCT02784470
• Recruitment Status: Unknown
• First Posted: May 27, 2016
• Last Update Posted: May 27, 2016
• Sponsor: Asan Medical Center
• Information provided by (Responsible Party): Moon-Won Yoo, Asan Medical Center

Tracking Information

• First Submitted Date: May 19, 2016
• First Posted Date: May 27, 2016
• Last Update Posted Date: May 27, 2016
• Study Start Date: October 2015
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 24, 2016): Gastric Outlet Obstruction Scoring System (GOOSS) score [ Time Frame: Up to 2 years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

• Device: gastroduodenal stent placement
• Procedure: gastrojejunostomy

Study Arms

• Experimental: gastrojejunostomy arm
  Intervention: Procedure: gastrojejunostomy
• Active Comparator: gastroduodenal stent placement
  Intervention: Device: gastroduodenal stent placement

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 24, 2016): 92
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2020
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02784470
• Other Study ID Numbers: 20151141
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Moon-Won Yoo, Asan Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Asan Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yoomoon Won, MD; Asan Medical Center

• PRS Account: Asan Medical Center
• Verification Date: May 2016