Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

NCT02784470 | Unknown Phase 3

• 1 other identifier: 20151141
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Gastric Outlet Obstruction Scoring System (GOOSS) score

  Up to 2 years

Study Arms (2)

gastrojejunostomy arm

EXPERIMENTAL

Procedure: gastrojejunostomy

gastroduodenal stent placement

ACTIVE COMPARATOR

Device: gastroduodenal stent placement

Interventions

gastroduodenal stent placement DEVICE

gastroduodenal stent placement

gastrojejunostomy PROCEDURE

gastrojejunostomy arm

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Yoomoon Won, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoomoon Won, MD

CONTACT

82-2-3010-3484; medigang@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 27, 2016
• Study Start: October 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2020
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

KR (1)