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

NCT ID: NCT02272894

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

510 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Gastric Cancer

Keywords

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Gastric Cancer D2 Lymphadenectomy Superior Mesenteric Vein Lymph Node

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

D2 Radical Gastrectomy Adding Dissection of the Superior Mesenteric Vein Lymph Node

Dissection of the Superior Mesenteric Vein Lymph Node

Intervention Type PROCEDURE

14v lymph node dissection

Group B

D2 Radical Gastrectomy

No interventions assigned to this group

Interventions

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Dissection of the Superior Mesenteric Vein Lymph Node

14v lymph node dissection

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Qingdao University

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Harbin Medical University

OTHER

Sponsor Role collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

Qinghai University

OTHER

Sponsor Role collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Wulumuqi General Hospital of Lanzhou Military Command

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Nanjing PLA General Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Han Liang, Master

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Hospital

Locations

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Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Han Liang, Master

Role: CONTACT

Phone: 086-022-23340123

Email: [email protected]

Facility Contacts

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Liang Han, Master

Role: primary

References

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Yang QC, Zhou HK, Yue C, Wang WD, Gao RQ, Mo ZC, Ji PP, Wei JP, Yang XS, Yu PF, Li XH, Ji G. [The correlation between No. 6 and No. 14v lymph node metastasis and the value of dissecting these lymph nodes in radical gastrectomy]. Zhonghua Wei Chang Wai Ke Za Zhi. 2023 Jan 25;26(1):38-43. doi: 10.3760/cma.j.cn441530-20221123-00491. Chinese.

Reference Type DERIVED
PMID: 36649998 (View on PubMed)

Other Identifiers

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E201419A

Identifier Type: -

Identifier Source: org_study_id