Clinical trial NCT02984787: 3D Versus 2D Laparoscopic Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Splenic Hilum Lymph Nodes Dissection
Keywords: Gastric Cancer
3D
2D
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 480
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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of splenic hilum 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: Poster-operative recovery course
timeFrame: 30 days
measure: Quality of life
timeFrame: 1 year
measure: 3-year disease free survival rate
timeFrame: 3 years
measure: 3-year overall survival rate
timeFrame: 3 years
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: