Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

NCT ID: NCT02784470

Last Updated: 2016-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2020-01-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

gastrojejunostomy arm

Group Type: EXPERIMENTAL

gastrojejunostomy

Intervention Type: PROCEDURE

gastroduodenal stent placement

Group Type: ACTIVE_COMPARATOR

gastroduodenal stent placement

Intervention Type: DEVICE

Interventions

gastroduodenal stent placement

Intervention Type: DEVICE

gastrojejunostomy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Moon-Won Yoo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoomoon Won, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yoomoon Won, MD

Role: CONTACT

medigang@hanmail.net

82-2-3010-3484

Other Identifiers

20151141

Identifier Type: -

Identifier Source: org_study_id