Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）for Advanced Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT01978444|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2013
Last Update Posted : April 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Procedure: Laparoscopic D2 lymphadenectomy plus CME Procedure: Laparoscopic D2 lymphadenectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||169 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||In this trial, patients and the follow-up staff are masked to the treatment allocation.|
|Official Title:||Prospective Randomized Controlled Trial of Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）vs. Laparoscopic D2 Lymphadenectomy for Advanced Gastric Cancer|
|Actual Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||October 2023|
Experimental: laparoscopic D2 lymphadenectomy plus CME
Laparoscopic D2 lymphadenectomy plus CME will be performed for the treatment of patients assigned to this group.
Procedure: Laparoscopic D2 lymphadenectomy plus CME
Active Comparator: laparoscopic D2 lymphadenectomy
Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Procedure: Laparoscopic D2 lymphadenectomy
- 3-year disease free survival [ Time Frame: 36 months ]3-years disease-free survival of the enrolled patients
- Postoperative recovery course [ Time Frame: 10 days ]Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay. The amount of abdominal drainage and blood transfusion are also recorded.
- Morbidity and mortality [ Time Frame: 30 days; 36 months ]
The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.
- 3-year overall survival rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- 3-year recurrence pattern [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
- 3-year overall survival [ Time Frame: 36 months ]3-years overall survival of the enrolled patients
- Postoperative intraperitoneal free cancer cell (IFCC) [ Time Frame: within 1hour ]Positive rate of cancer cells from intraperitoneal wash samples after gastrectomy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978444
|Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology|
|Wuhan, Hubei, China, 430030|
|Principal Investigator:||Jianping Gong, M.D.,Ph.D.||Huazhong University of Science and Technology|