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

NCT ID: NCT01978444

Last Updated: 2020-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2023-10-31

Brief Summary

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

laparoscopic D2 lymphadenectomy plus CME

Laparoscopic D2 lymphadenectomy plus CME will be performed for the treatment of patients assigned to this group.

Group Type: EXPERIMENTAL

Laparoscopic D2 lymphadenectomy plus CME

Intervention Type: PROCEDURE

laparoscopic D2 lymphadenectomy

Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Group Type: ACTIVE_COMPARATOR

Laparoscopic D2 lymphadenectomy

Intervention Type: PROCEDURE

Interventions

Laparoscopic D2 lymphadenectomy plus CME

Intervention Type: PROCEDURE

Laparoscopic D2 lymphadenectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Jianping Gong

Director of Department of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianping Gong, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Huazhong University of Science and Technology

Locations

Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

References

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Other Identifiers

TJ-20131101

Identifier Type: -

Identifier Source: org_study_id