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Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gastroduodenal stent placement
gastrojejunostomy
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gastrojejunostomy arm

gastroduodenal stent placement

Arm Description

Outcomes

Primary Outcome Measures

Gastric Outlet Obstruction Scoring System (GOOSS) score

Secondary Outcome Measures

Full Information

First Posted
May 19, 2016
Last Updated
May 24, 2016
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02784470
Brief Title
Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gastrojejunostomy arm
Arm Type
Experimental
Arm Title
gastroduodenal stent placement
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
gastroduodenal stent placement
Intervention Type
Procedure
Intervention Name(s)
gastrojejunostomy
Primary Outcome Measure Information:
Title
Gastric Outlet Obstruction Scoring System (GOOSS) score
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoomoon Won, MD
Phone
82-2-3010-3484
Email
medigang@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoomoon Won, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy

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