Clinical trial NCT02711033: Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection
Official title: Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Splenic Hilum Lymph Nodes Dissection
Total Gastrectomy
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy.

Detailed description: For advanced proximal gastric cancer, total gastrectomy with D2 lymphadenectomy is the standard surgical therapy. Apparently, lymph nodes (LNs) dissection along the splenic artery (No.11) and the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines. Nevertheless, complete removal of the No. 10 and No. 11d LNs is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic-assisted total gastrectomy (LATG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Herein, we aim to investigate the safety and feasibility of LATG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy (OTG).

Eligibility criteria: Inclusion Criteria:

* Patient with advanced proximal gastric cancer （T2-T4a,N0-N3,M0）
* Informed consent
* Eastern Cooperative Oncology Group (ECOG): 0 ot 1
* American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ

Exclusion Criteria:

* Pregnancy or female in suckling period
* Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
* Severe mental disease
* Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor
* Body mass index (BMI) \> 30 kg/m2

Primary outcomes:
measure: Early complication rate
timeFrame: 30 days
Secondary outcomes:
measure: Operative time
timeFrame: Intraoperative
measure: Time of splenic hilum lymph nodes dissection
timeFrame: Intraoperative
measure: Operative blood loss
timeFrame: Intraoperative
measure: Incision length
timeFrame: 7 days
measure: Number of total lymph nodes harvested
timeFrame: 7 days
measure: Number of group No.10 lymph nodes harvested
timeFrame: 7 days
measure: Number of lymph nodes posterior to splenic vessel
timeFrame: 7 days
measure: Poster-operative recovery course
timeFrame: 30 days
measure: 3-year disease free survival rate
timeFrame: 3 years
measure: 5-year overall survival rate
timeFrame: 5 years
measure: Metastasis rate of lymph nodes posterior to splenic vessel
timeFrame: 7 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
name: Wei Wang, M.D., PH.D.
role: PRINCIPAL_INVESTIGATOR
References: