Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02784470
• Other study ID #: 20151141
• Status: Recruiting
• Phase: Phase 3
• First received: May 19, 2016
• Last updated: May 24, 2016
• Start date: October 2015
• Est. completion date: January 2020

Study information

• Verified date: May 2016
• Source: Asan Medical Center
• Contact: Yoomoon Won, MD
• Phone: 82-2-3010-3484
• Email: medigang[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: January 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer

Intervention

Device:
• gastroduodenal stent placement

Procedure:
• gastrojejunostomy

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric Outlet Obstruction Scoring System (GOOSS) score		Up to 2 years	Yes