Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    170
  • sponsor
    Beijing Cancer Hospital
Updated on 15 February 2022
gastrectomy
cancer
tubular
gastric adenocarcinoma
lymphadenectomy
adenocarcinoma of the gastroesophageal junction
gastric cancer
adenocarcinoma
endoscopic biopsy
primary lesion
lymph node dissection

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.

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.

Details
Condition Gastric Cancer, Gastrectomy, Laparoscopic Surgery, Lymphadenectomy
Treatment laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection
Clinical Study IdentifierNCT03708783
SponsorBeijing Cancer Hospital
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

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
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