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Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision(D2+CME)for Advanced Gastric Cancer

H

Huazhong University of Science and Technology

Status

Unknown

Conditions

Gastric Cancer

Treatments

Procedure: Laparoscopic D2 lymphadenectomy
Procedure: Laparoscopic D2 lymphadenectomy plus CME

Study type

Interventional

Funder types

Other

Identifiers

NCT01978444
TJ-20131101

Details and patient eligibility

About

Radical gastrectomy for gastric cancer with D2 lymph node dissection has been widely applied in advanced gastric cancer. However,for most patients,tumor local-regional recurrence has been proven unavoidable.

Recently, many clinical studies have proved that some cancer cells and cancer nodes exist in the mesogastrium which can be hardly removed by conventional radical gastrectomy with D2 lymphadenectomy. It is suggested that Complete mesogastrium excision (CME) is imperative and should be added to D2 lymphadenectomy in order to reduce the risk of local recurrence.

Thus, the comparison of short-term and long-term outcome between laparoscopic D2 lymphadenectomy plus complete mesogastrium excision and conventional laparoscopic D2 lymphadenectomy for locally advanced gastric cancer based on a well designed randomized controlled trial is needed.

Enrollment

169 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age from over 18 to under 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition Expected curative resection through gastrectomy with D2 lymphadenectomy Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) score class I, II, or III Informed consent obtained from patients or their appointed agent

Exclusion criteria

Patients treated with neoadjuvant chemotherapy or radiation therapy; Patients with history of upper abdominal surgery; History with other severe comorbidities and cannot tolerate laparoscopic surgery, such as severe heart and lung diseases, heart function below clinical stage 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc; Patients suffering from malignant diseases before the study or with other gastric malignant diseases, such as lymphoma and stromal tumors, etc.; Pregnant woman and woman during lactation; Patients with mental sickness; The patient compliance is bad or the researcher expect there will not be good patient compliance;

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

169 participants in 2 patient groups

laparoscopic D2 lymphadenectomy plus CME
Experimental group
Description:
Laparoscopic D2 lymphadenectomy plus CME will be performed for the treatment of patients assigned to this group.
Treatment:
Procedure: Laparoscopic D2 lymphadenectomy plus CME
laparoscopic D2 lymphadenectomy
Active Comparator group
Description:
Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Treatment:
Procedure: Laparoscopic D2 lymphadenectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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