Stomach Neoplasms Clinical Trial
Official title:
Safety and Feasibility of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Locally Advanced Upper Third Gastric Cancer: A Multicenter Phase II Trial
The purpose of this study is to explore the safety and feasibility of the Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper third gastric adenocarcinoma(cT2-4a, N-/+, M0).
Radical resection is still the primary method of treating advanced gastric cancer.According
to the Japanese treatment guidelines for gastric cancer, D2 lymphadenectomy, including No. 10
lymph node dissection, should be adopted for upper third gastric carcinoma.The incidence of
No. 10 lymph node metastasis is high in advanced proximal gastric cancer, reported to range
from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is closely related to
survival. Therefore, in East Asia, D2 lymph node dissection of potentially curable locally
advanced upper third gastric cancer including No. 10 lymph node is the standard surgical
treatment.
In the early, splenectomy was performed to remove No. 10 lymph node. With the improvement of
medical knowledge and surgical technique, spleen-preserving No. 10 lymph node dissection has
been recognized by more and more surgeons. However, due to the special and complex anatomy of
the spleen, spleen-preserving No. 10 lymph node dissection is difficult, even in open
surgery; consequently, the surgery cannot be performed in many centers.
Laparoscopic surgery has distinct minimally invasive advantages, such as small incisions,
less blood loss, less postoperative pain, mild postoperative inflammatory reactions, a quick
recovery of gastrointestinal function, shorter hospital stays and obvious cosmetic effects.
Since Kitano et al. first reported laparoscopic gastrectomy for gastric cancer in 1994,
laparoscopic techniques have developed rapidly. The techniques are becoming increasingly
mature, making it possible to perform laparoscopic spleen-preserving No. 10 lymph node
dissection. Our center first proposed "Huang's three-step maneuver", a new operative method
suitable for laparoscopic spleen-preserving No. 10 lymph node dissection. This method
simplifies the procedure of laparoscopic spleen-preserving No. 10 lymph node dissection and
facilitates its popularization and promotion.
However, it remains a controversial international issue if it is safe and feasible to
routinely conduct laparoscopic spleen-preserving No. 10 lymph node dissection for advanced
upper third gastric cancer.A number of retrospective studies have successively confirmed the
safety, feasibility and oncological efficacy of laparoscopic spleen-preserving No. 10 lymph
node dissection.But there is no multicenter prospective studies to identify the results.
Therefore, The study is through a prospective, multicenter, open, single-arm, non-inferiority
study,to explore the safety and feasibility of the laparoscopic spleen-preserving No. 10
lymph node dissection for patients with locally advanced upper third gastric
adenocarcinoma(cT2-4a, N-/+, M0).
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