Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection

Gastric Cancer Clinical Trial

Official title:

Laparoscopic Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02980861
• Other study ID #: Z161100000516237
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 30, 2016
• Last updated: December 5, 2016
• Start date: January 2017
• Est. completion date: June 2020

Study information

• Verified date: December 2016
• Source: Chinese PLA General Hospital
• Contact: Hongqing Xi, Master
• Phone: 010-66938128
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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: ?to ?;

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic total gastrectomy
When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.
• Open total gastrectomy
When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of group Splenic Hilum (No.10) lymph nodes harvested		7 days	Yes
Secondary	Early complication rate	The early complication rate is defined as the event observed during operation	30 days	Yes
Secondary	Operative time		Intraoperative	Yes
Secondary	Operative blood loss		Intraoperative	Yes
Secondary	Time of splenic hilum lymph nodes dissection		Intraoperative	No
Secondary	Number of total lymph nodes harvested		7 days	No
Secondary	Post-operative recovery course	Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course	30 days	No
Secondary	3-year disease free survival rate		3 years	No
Secondary	3-year overall survival rate		3 years	No
Secondary	Quality of life	It will be assessed by questionnaire (WHO quality of life-100)	1 year	No