Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02711033
• Other study ID #: GDPHCM-GI-01
• Status: Recruiting
• Phase: Phase 2
• First received: March 9, 2016
• Last updated: April 7, 2017
• Start date: October 2015
• Est. completion date: April 2019

Study information

• Verified date: April 2017
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Wei Wang, M.D., PH.D.
• Phone: +86-13922255515
• Email: wangwei16400[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: April 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: ?to ?

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

Related Conditions & MeSH terms

• Gastric Cancer
• Splenic Hilum Lymph Nodes Dissection
• Stomach Neoplasms
• Total Gastrectomy

Intervention

Procedure:
• Laparoscopic-assisted total gastrectomy
When patients with advanced proximal gastric cancer are randomized in the laparoscopic-assisted total gastrectomy (LATG) group, they will received LATG with spleen-preserving splenic hilum lymph nodes dissection.
• Open total gastrectomy
When patients 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	Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early complication rate	The early complication rate is defined as the event observed during operation and within 30 days after surgery.	30 days
Secondary	Operative time		Intraoperative
Secondary	Time of splenic hilum lymph nodes dissection		Intraoperative
Secondary	Operative blood loss	It will be assessed with the unit of "ml".	Intraoperative
Secondary	Incision length		7 days
Secondary	Number of total lymph nodes harvested		7 days
Secondary	Number of group No.10 lymph nodes harvested		7 days
Secondary	Number of lymph nodes posterior to splenic vessel		7 days
Secondary	Poster-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
Secondary	3-year disease free survival rate		3 years
Secondary	5-year overall survival rate		5 years
Secondary	Metastasis rate of lymph nodes posterior to splenic vessel		7 days