search
Back to results

Diffusion Weighted Magnetic Resonance Imaging for Preoperative Staging in Gastric Adenocarcinoma Patients

Primary Purpose

Gastric Adenocarcinoma

Status
Completed
Phase
Early Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
diffusion weighted magnetic resonance imaging
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Adenocarcinoma focused on measuring diffusion weighted, magnetic resonance imaging, surgery, histopathology

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • gastric adenocarcinoma proven by endoscopic biopsy;
  • application of both computed tomography and diffusion weighted magnetic resonance imaging;
  • standard gastrectomy and a D2 lymph node dissection;
  • desire to attend the study protocol

Exclusion Criteria:

  • preoperative neoadjuvant therapy;
  • metastatic disease;
  • undesired reaction to attend the study protocol

Sites / Locations

  • Bezmialem Vakif University Faculty of Medicine Dept of General Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

diffusion MRI

Arm Description

histopathology of lymph nodes diagnosed by diffusion weighted magnetic resonance imaging

Outcomes

Primary Outcome Measures

efficacy of diffusion weighted magnetic resonance imaging to detect benign and malignant lymph nodes
to compare the radiologic diagnosis of benign and malignant lymph nodes with histopathological diagnosis

Secondary Outcome Measures

Full Information

First Posted
February 15, 2013
Last Updated
February 28, 2017
Sponsor
Bezmialem Vakif University
search

1. Study Identification

Unique Protocol Identification Number
NCT01794026
Brief Title
Diffusion Weighted Magnetic Resonance Imaging for Preoperative Staging in Gastric Adenocarcinoma Patients
Official Title
Use of Diffusion Weighted Magnetic Resonance Imaging to Stage Gastric Adenocarcinoma Patients Preoperatively
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced disease stateS for the patients in which the surgery may be unnecessary to perform. Although there are many imaging techniques for this purpose, sensitivity and specificity of these techniques still remains to be low.Preoperative detection of peritoneal carcinomatosis and involvement of lymph nodes beyond D2 may prevent surgical procedures. Removal of the determined lymph nodes according to the type of the surgery is the accepted surgical method. However, accurate determination of malignant lymph nodes may prevent dissection of some groups of the lymph nodes. These findings may cause a new definition of gastric lymph node dissection.
Detailed Description
proven endoscopic diagnosis of gastric adenocarcinoma for staging purposes, computed tomography for all patients evaluation of benign and malignant lymph nodes according to computed tomography findings and mapping of the lymph nodes to state precisely resectable patients according to computed tomography and anesthetic evaluation evaluation of benign and malignant lymph nodes according to diffusion weighted magnetic resonance imaging findings and mapping of the lymph nodes standard gastrectomy and D2 lymph node dissection mapping of the lymph nodes after taking the specimen out histopathological diagnosis of the lymph nodes and mapping comparison of the results taken from computed tomography, diffusion weighted magnetic resonance imaging and histopathological analysis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
diffusion weighted, magnetic resonance imaging, surgery, histopathology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diffusion MRI
Arm Type
Experimental
Arm Description
histopathology of lymph nodes diagnosed by diffusion weighted magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
diffusion weighted magnetic resonance imaging
Intervention Description
for diagnostic purposes, diffusion weighted magnetic resonance imaging in all patients
Primary Outcome Measure Information:
Title
efficacy of diffusion weighted magnetic resonance imaging to detect benign and malignant lymph nodes
Description
to compare the radiologic diagnosis of benign and malignant lymph nodes with histopathological diagnosis
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gastric adenocarcinoma proven by endoscopic biopsy; application of both computed tomography and diffusion weighted magnetic resonance imaging; standard gastrectomy and a D2 lymph node dissection; desire to attend the study protocol Exclusion Criteria: preoperative neoadjuvant therapy; metastatic disease; undesired reaction to attend the study protocol
Facility Information:
Facility Name
Bezmialem Vakif University Faculty of Medicine Dept of General Surgery
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Diffusion Weighted Magnetic Resonance Imaging for Preoperative Staging in Gastric Adenocarcinoma Patients

We'll reach out to this number within 24 hrs