Skip to main content
OpenTrials
Completed

NCT Number: NCT02926716

NBI for Identifying Resection Margin Status in Gastric Cancer

As the proportion of early gastric cancer has been steadily increased in Korea, so has function-preserving surgery. The function preserving surgery is characterized by the minimized extent of gastrectomy, so this implies that bilateral margins are getting shorter than those of standard gastrectomies.

Currently, there is only one way to identify resection margin status in gastric cancer, 'frozen biopsy'. However, it is labor-intensive and time-consuming procedure. In addition, the results rely on the pathologist's expertise, thereby it showed limitation of its accuracy; high false negative rate of signet ring cell carcinoma was reported in a previous study.

Recently, many studies on magnifying endoscopy with narrow band imaging(NBI) demonstrated that this emerging technique is useful to identify the gastric tumor margin more clearly in vivo, compared with conventional indigocarmine chromoendoscopy. So it was hypothesized that NBI may allow reliable delineation of tumor and identification of resection margin status in the specimen after gastrectomy for gastric cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou University School of Medicine

Suwan, Gyeonggi-do, 443-749, South Korea

About this study

  • Tumor delineation and identification of resection margin:

After specimen delivery from the abdomen, frozen biopsy is performed before checking tumor margin. After inspection with NBI, the tumor margin is marked with electrocauterization. The tumor size and the lengths of both resection margins are evaluated using a ruler.

  • Pathologic examination:

The specimen is sliced as 4mm interval paralleled to the markings. Tumor size, the status of both resection margins, and microvessel density are evaluated under the 200 magnified view.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient from over 20 to under 90 years
  • The patient who is diagnosed as gastric cancer clinically by endoscopy or computed tomography
  • The patient who is informed and consent about the purpose and contents of this study prior to the participation in this study

Exclusion criteria

  • The patient who shows far advanced gastric cancer preoperatively or intraoperatively
  • The patient with previous medical history of other treatment for gastric caner such as endoscopic resection, chemotherapy, radiation, immunotherapy, and so on

Treatment and study plan

Primary outcomes

  1. Accuracy for identifying the status of resection margin

    Time frame: 2 weeks

    The status of resection margin assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 2 weeks

Secondary outcomes

  1. Tumor size

    Time frame: 2 weeks

    The tumor size assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 2 weeks

  2. Microvessel density

    Time frame: 4 weeks

    The status of resection margin assessed by NBI during the operation is confirmed by the pathologic examination at postoperative 4 weeks

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

Efficacy of Narrow Band Imaging Technique for Identifying Resection Margin Status After Gastrectomy for Gastric Cancer

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2016
Registry last updated
Feb 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.