Effect of Lymph Node Ratio in Gastric Cancer to Determine Recurrence Rate After Curative Resection

Gastric Cancer Clinical Trial

Official title:

Effect of Lymph Node Ratio in Gastric Cancer to Determine Recurrence Rate After Curative Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778710
• Other study ID #: 2018/633
• Status: Completed
• Start date: December 18, 2018
• Est. completion date: February 20, 2019

Study information

• Verified date: March 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

D2 gastrectomy is standard treatment of early gastric cancer in Japan but in other countries there is still some discord, especially in Europe and North America. Although the quantity of metastasis cancer in lymph node defines survival regardless of which country the patient is treated, the total number of lymph nodes harvested is an important factor to predict accurate staging and/or D2 gastrectomy. Both of the number total lymph nodes and the metastasis lymph node status in gastric cancer are important factors to decide each prognosis. This study evaluated the correlation between total lymph nodes retrieved and metastasis node by lymph node ratio (LNR) status to determine the recurrence rate after curative resection of gastric

Description:

A retrospective chart review was made of all patients who presented with gastric cancer after curative surgery resection from January 1, 1995 to December 31, 2016 in Ramathibodi Hospital.Data of metastasis node by lymph node ratio (LNR) were evaluated. The total of lymph node less than 15 and more than 15 were evaluated. The Kaplan-Meier curve estimates recurrence survival (Log-rank test). The p-value < 0.05 is statistically significant.

OBJECTIVE :

The outcome of this study was evaluated lymph node ratio (LNR) status that determined by the ratio of total lymph node metastasis and the total lymph node which retrieved after performed the curative surgery and lymphadenectomy of gastric cancer. The correlation of LNR and prognosis of recurrence and survival of gastric cancer patients were evaluated and reported in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: February 20, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Gastric cancer after curative surgery resection

• No received neoadjuvant therapy

• Patients have tissues confirmed by Pathology

• Staging used esophagogastroduodenoscopy (EGD) or imaging, including ultrasonography, Computer Tomography (CT) or Magnetic Resonance Imaging (MRI

• Surgery was performed for curative intent and D2 lymphadenectomy and according from Japanese guideline for gastric cancer

Exclusion Criteria:

• Distant metastasis during surgery

Related Conditions & MeSH terms

• Gastric Cancer
• Recurrence
• Stomach Neoplasms

Locations

Country	Name	City	State
Thailand	Chairat Supsamutchai	Bangkok	Bankok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation of lymph node ratio and survival of gastric cancer patients	correlation of lymph node ratio and survival of gastric cancer patients.lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.	5 year
Primary	The correlation of lymph node ratio and prognosis of recurrence of gastric cancer patients	correlation of lymph node ratio and recurrence of gastric cancer patients.lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.	5 year
Secondary	The correlation of total of lymph node retrieved less than 15 and more than 15 nodes and survival of gastric cancer patients	correlation of total of lymph node retrieved less than 15 and more than 15 nodes and survival of gastric cancer patients..lymph node ratio was divided in to 5 ranges including 0.000-0.109, 0.110-0.209, 0.210-0.309, 0.410-0.609 and 0.610-1.000.	5 year