3D Versus 2D Laparoscopic Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection

Splenic Hilum Lymph Nodes Dissection Clinical Trial

Official title:

3D Versus 2D Laparoscopic 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: NCT02984787
• Other study ID #: Experiment20161201
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 1, 2016
• Last updated: December 4, 2016
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: December 2016
• Source: Chinese PLA General Hospital
• Contact: Hongqing Xi, Master
• Phone: 86-13801290395
• Email: chenlinbj[@]sina.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial Summary

The investigators will perform a prospective randomized comparison between 3D and 2D laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.

Description:

A prospective randomized comparison of 3D and 2D laparoscopic surgery for advanced gastric cancer with spleen-preserving splenic hilum lymph nodes dissection will be performed, to evaluate the safety and feasibility for the extensive application of the novel 3D laparoscopic technique. The evaluation parameters are number of group No.10 lymph nodes harvested, perioperative clinical efficacy, postoperative life quality and 3-year survival and recurrence rates.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: January 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 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

• Splenic Hilum Lymph Nodes Dissection

Intervention

Procedure:
• 3D Laparoscopic total gastrectomy
When participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection
• 2D Laparoscopic total gastrectomy
When participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of splenic hilum lymph nodes harvested		7 days	No
Secondary	Early complication rate	The early complication rate is defined as the event observed during operation and within 30 days after surgery.	30 days	Yes
Secondary	Operative time	It will be assessed with the unit of "minute".	Intraoperative	Yes
Secondary	Operative blood loss	It will be assessed with the unit of "ml".	Intraoperative	Yes
Secondary	Time of splenic hilum lymph nodes dissection	It will be assessed with the unit of "minute"	Intraoperative	No
Secondary	Number of total lymph nodes harvested		7 days	No
Secondary	Poster-operative recovery course	Time to first ambulation (unit of hour), flatus (unit of hour), liquid diet (unit of hour) and duration of hospital stay (unit of day) are used to assess the postoperative recovery course.	30 days	No
Secondary	Quality of life	It will be assessed with questionnaire of "WHO-QOL-100" (WHO was short for world health organization)	1 year	No
Secondary	3-year disease free survival rate		3 years	No
Secondary	3-year overall survival rate		3 years	No