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

Phase 3

• Conditions: Splenic Hilum Lymph Nodes Dissection
• Interventions: Procedure: 2D Laparoscopic total gastrectomy; Procedure: 3D Laparoscopic total gastrectomy

• Registration Number: NCT02984787
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-04
• Last Update Submitted: 2016-12-04
• Study First Posted: 2016-12-07
• Last Update Posted: 2016-12-07
• Study Start: 2017-01
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2D Laparoscopic total gastrectomy	2D Laparoscopic total gastrectomy	Participants including in the 2D laparoscopic total gastrectomy (2D-LTG) group will undergo 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection.
3D Laparoscopic total gastrectomy	3D Laparoscopic total gastrectomy	Participants including in the 3D laparoscopic total gastrectomy (3D-LTG) group will undergo 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection.

Primary Outcome Measures

Name	Time	Method
Number of splenic hilum lymph nodes harvested	7 days

Secondary Outcome Measures

Name	Time	Method
Early complication rate	30 days	The early complication rate is defined as the event observed during operation and within 30 days after surgery.
Operative time	Intraoperative	It will be assessed with the unit of "minute".
Operative blood loss	Intraoperative	It will be assessed with the unit of "ml".
Time of splenic hilum lymph nodes dissection	Intraoperative	It will be assessed with the unit of "minute"
Number of total lymph nodes harvested	7 days
Poster-operative recovery course	30 days	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.
Quality of life	1 year	It will be assessed with questionnaire of "WHO-QOL-100" (WHO was short for world health organization)
3-year disease free survival rate	3 years
3-year overall survival rate	3 years

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China