Clinical trial NCT02980861: Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection
Official title: Laparoscopic 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: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Splenic Hilum Lymph Nodes Dissection
Gastrectomy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 200
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: Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.

Detailed description: Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 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 total gastrectomy (LTG) 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. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare the early results of this procedure with open total gastrectomy (OTG).

Eligibility criteria: Inclusion Criteria:

1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
2. cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition.
3. Eastern Cooperative Oncology Group (ECOG): 0 or 1;
4. American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
5. Written informed consent.

Exclusion Criteria:

1. Pregnant or breast-feeding women;
2. Severe mental disorder;
3. Previous upper abdominal surgery (except laparoscopic cholecystectomy);
4. Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
5. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
6. Other malignant disease within the past 5 years;
7. Previous neoadjuvant chemotherapy or radiotherapy;
8. Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
9. Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.

Primary outcomes:
measure: Number of group Splenic Hilum (No.10) lymph nodes harvested
timeFrame: 7 days
Secondary outcomes:
measure: Early complication rate
timeFrame: 30 days
measure: Operative time
timeFrame: Intraoperative
measure: Operative blood loss
timeFrame: Intraoperative
measure: Time of splenic hilum lymph nodes dissection
timeFrame: Intraoperative
measure: Number of total lymph nodes harvested
timeFrame: 7 days
measure: Post-operative recovery course
timeFrame: 30 days
measure: 3-year disease free survival rate
timeFrame: 3 years
measure: 3-year overall survival rate
timeFrame: 3 years
measure: Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: the Chinese PLA General Hospital
name: Lin Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.
citation: Guo X, Peng Z, Lv X, Cui J, Zhang K, Li J, Jin N, Xi H, Wei B, Chen L. Randomized controlled trial comparing short-term outcomes of laparoscopic and open spleen-preserving splenic hilar lymphadenectomy for advanced proximal gastric cancer: An interim report. J Surg Oncol. 2018 Dec;118(8):1264-1270. doi: 10.1002/jso.25262. Epub 2018 Oct 31.