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NCT Number: NCT01794026

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Bezmialem Vakif University Faculty of Medicine Dept of General Surgery

Istanbul, 34093, Turkey (Türkiye)

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffusion Weighted Magnetic Resonance Imaging

Procedure

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

Primary outcomes

  1. efficacy of diffusion weighted magnetic resonance imaging to detect benign and malignant lymph nodes

    Time frame: one year

    to compare the radiologic diagnosis of benign and malignant lymph nodes with histopathological diagnosis

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 18, 2013
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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