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NBI for Identifying Resection Margin Status in Gastric Cancer

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ClinicalTrials.gov Identifier: NCT02926716
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Sang-Uk Han, Ajou University School of Medicine

Brief Summary:

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.


Condition or disease
Gastric Cancer

Detailed Description:
  1. 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.

  2. 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.


Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy of Narrow Band Imaging Technique for Identifying Resection Margin Status After Gastrectomy for Gastric Cancer
Actual Study Start Date : December 14, 2015
Actual Primary Completion Date : December 29, 2016
Actual Study Completion Date : December 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient who is diagnosed as early staged gastric cancer preoperatively
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926716


Locations
Korea, Republic of
Ajou University School of Medicine
Suwan, Gyeonggi-do, Korea, Republic of, 443-749
Sponsors and Collaborators
Ajou University School of Medicine

Additional Information:
Publications:
Responsible Party: Sang-Uk Han, Professor, Department of Surgery, Ajou University School of Medicine, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02926716     History of Changes
Other Study ID Numbers: AJIRB-MED-SMP-15-10
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Sang-Uk Han, Ajou University School of Medicine:
Stomach neoplasm
Endoscopy
Narrow band imaging

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases