A Trial to Evaluate the Superior Mesenteric Vein (14V) Lymphadenectomy for Distal Advanced Gastric Cancer

Randomized Controlled Trial to Evaluate Mesenteric Vein (14V) Lymphadenectomy for Gastric Cancer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02272894

Enrollment

510

Registered

2014-10-23

Start date

2014-07-31

Completion date

2016-12-31

Last updated

2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Gastric Cancer, D2 Lymphadenectomy, Superior Mesenteric Vein Lymph Node

Brief summary

This trial is going to evaluate the advantage of D2 radical gastrectomy plus 14v lymph node dissection in 3-year survival rates of advanced gastric cancers.

Detailed description

Radical surgery is still the only possible way to cure gastric cancer. In Japan, South Korea and other countries, due to the popularity of screening and Improved surgical procedures, there has been great improvement in overall survival. Standard D2 Gastrectomy has been the standard operation for advanced gastric cancer. However, there is no unanimous consensus whether Standard D2 Gastrectomy plus 14v lymph node dissection is needed.Till now, it is difficult to stage the 14V lymph node as regional lymph nodes metastasis or distant metastasis. And it is urgent to explore the necessity of 14v lymph node dissection in advanced gastric cancer.So a prospective randomized controlled study will to carry out to evaluate the effects of D2 radical gastrectomy plus 14v lymph node dissection compared with D2 radical gastrectomy.

Interventions

PROCEDUREDissection of the Superior Mesenteric Vein Lymph Node

14v lymph node dissection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Curative D2 or D2+ operation had been performed; * Physical condition and organ function allows to tolerable abdominal surgery; * Willing and able to comply with the program during the study period; * Aged 18 to 70 years, preoperative gastric cancer patients with pathologically confirmed; * With more than a 6-month life expectancy; * No other serious concomitant diseases; * No adjuvant chemotherapy before recurrence; * Karnofsky performance status scale ≥ 60; * All patients accept 6 cycles XELOX chemotherapy regimen

Exclusion criteria

* Pregnancy or breast feeding; * Women of childbearing age do not take contraceptive measures; * Organ transplantation patients need immunosuppressive therapy; * Five years after the trial begin,other malignant tumor occur; * While using other experimental drug or other clinical trials are being; * Can not take oral medications; * Mentally disordered; * Severe recurrent infections were not controlled or with other serious concomitant diseases;

Design outcomes

Primary

Measure	Time frame	Description
overall survival	3 years	Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons.

Secondary

Measure	Time frame	Description
disease free survival	3 years	Disease free survival (DFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.

Countries

China

Contacts

Primary ContactHan Liang, Master

tjlianghan@126.com086-022-23340123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026