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

Gastric Adenocarcinoma Clinical Trial

Official title:

Use of Diffusion Weighted Magnetic Resonance Imaging to Stage Gastric Adenocarcinoma Patients Preoperatively

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794026
• Other study ID #: DWMRIGASTADENO
• Status: Completed
• Phase: Early Phase 1
• First received: February 15, 2013
• Last updated: February 28, 2017
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. proven endoscopic diagnosis of gastric adenocarcinoma

2. for staging purposes, computed tomography for all patients

3. evaluation of benign and malignant lymph nodes according to computed tomography findings and mapping of the lymph nodes

4. to state precisely resectable patients according to computed tomography and anesthetic evaluation

5. evaluation of benign and malignant lymph nodes according to diffusion weighted magnetic resonance imaging findings and mapping of the lymph nodes

6. standard gastrectomy and D2 lymph node dissection

7. mapping of the lymph nodes after taking the specimen out

8. histopathological diagnosis of the lymph nodes and mapping

9. comparison of the results taken from computed tomography, diffusion weighted magnetic resonance imaging and histopathological analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Body Weight
• Gastric Adenocarcinoma

Intervention

Procedure:
• diffusion weighted magnetic resonance imaging
for diagnostic purposes, diffusion weighted magnetic resonance imaging in all patients

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University Faculty of Medicine Dept of General Surgery	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year