Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

Asan Medical Center

Status and phase

Unknown

Phase 3

Conditions

Gastric Cancer

Treatments

Device: gastroduodenal stent placement

Procedure: gastrojejunostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02784470

20151141

Details and patient eligibility

About

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.

Enrollment

92 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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