Clinical trial NCT03778710: Effect of Lymph Node Ratio in Gastric Cancer to Determine Recurrence Rate After Curative Resection
Official title: Effect of Lymph Node Ratio in Gastric Cancer to Determine Recurrence Rate After Curative Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Lymph node metastasis, Gastric cancer
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who presented with gastric cancer after curative surgery resection from January 1, 1995 to December 31, 2016 in Ramathibodi Hospital.

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The correlation of lymph node ratio and survival of gastric cancer patients
timeFrame: 5 year
measure: The correlation of lymph node ratio and prognosis of recurrence of gastric cancer patients
timeFrame: 5 year
Secondary outcomes:
measure: The correlation of total of lymph node retrieved less than 15 and more than 15 nodes and survival of gastric cancer patients
timeFrame: 5 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chairat Supsamutchai
state: Bankok
Study officials:
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
name: Chairat Supsamutchai, MD
role: STUDY_CHAIR
References: