Clinical trial NCT03708783: Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC
Official title: Study on Short and Long-term Outcome of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Gastrectomy
Laparoscopic Surgery
Lymphadenectomy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with locally advanced upper and middle third gastric cancer will receive laparoscopic total gastrectomy with D2 lymphadenectomy including No. 10 lymph node dissection.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the safety and feasibility of laparoscopic spleen-preserving No. 10 lymph node dissection for patients with advanced middle or upper third gastric cancer.

Detailed description: Radical resection is the primary treatment for patients with advanced middle or upper third gastric cancer. And D2 lymphadenectomy, including No. 10 lymph node dissection, should be performed according to the Japanese treatment guidelines for gastric cancer. Because of the complexity of the anatomy around the spleen, spleen-preserving No. 10 lymph node dissection is difficult. Although Professor Huang from Fujian Medical University Union Hospital has proposed the "Huang's three-step maneuver" to dissect No. 10 lymph node with preserved spleen laparoscopically, such method is far from popularized, especially in North China. In addition, the safety, feasibility and oncological efficacy of this method was not confirmed in such area, either.

In this study, a prospective, single center, single-arm, non-inferiority clinical trial will be conducted to evaluate the short and long-term outcome of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced middle or upper third gastric cancer in Beijing.

Eligibility criteria: Inclusion Criteria:

* Patients age older than 18 years (including 18 years old);
* The primary lesion is located in the upper or middle third of the stomach, including Siewert II type and Siewert III type adenocarcinoma of the esophagogastric junction;
* Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy (including papillary, tubular, mucinous, signet ring cell and poorly differentiated adenocarcinoma);
* Preoperative cancer stage cT2-4aN0-3M0 (according to AJCC-7th TNM staging);
* The Eastern Cooperative Oncology Group performance status of 0 or 1;
* The American Society of Anesthesiology classes of I, II or III;
* Signed Informed consent.

Exclusion Criteria:

* Pregnant or lactating women;
* Suffering from severe mental disorder;
* Previous gastrectomy, including endoscopic submucosal dissection and endoscopic mucosal resection;
* Integrated or enlarged lymph node with maximum diameter larger than 3 cm according to preoperative imaging, including significantly enlarged or bulky No. 10 lymph nodes;
* Siewert I type adenocarcinoma of the esophagogastric junction;
* Other malignant diseases (within 5 years);
* Other illnesses needed operation concurrently;
* Complications (bleeding, perforation or obstruction) required emergency surgery due to primary gastric malignancy;
* Pulmonary function tests FEV1 less than 50% of predicted value;
* Patient suffered from bleeding tendency disease such as hemophilia or took anti-coagulant medication due to deep vein thrombosis.
* Patients with obvious tumor infiltration in the spleen and splenic vessels which require splenectomy.

Primary outcomes:
measure: the incidence of postoperative complications within 30 days
timeFrame: 30 days
Secondary outcomes:
measure: 3-year disease free survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: