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NCT05707338
Short-term Outcomes of Laparoscopic Versus Open Gastrectomy With Lymph Node Dissection for Early Gastric Cancer :a Randomized Controlled Study
Conditions: Early Gastric Cancer
Sex: All
Phase: NA
Enrollment: 40
Sponsor: Sohag University
Summary
While the incidence of gastric cancer is gradually declining, it is the fifth most common cancer worldwide and the third most common cause of cancer related death worldwide according to GLOBOCAN 2018 data (Rawla P and Barsouk A.,2019).Laparoscopic distal gastrectomy for early gastric cancer(EGC) was first performed more than 20 years ago (Shi, Y et al.,2018).
Laparoscopy-assisted gastrectomy (LAG) for EGC has been confirmed to have oncologic and long-term survival equivalency to the open technique and provide tremendous advantages over open surgery, such as good cosmesis, reduced pain, and shorter hospital stay(Katai H et al.,2017).Based on the experience of EGC, most experienced surgeons have applied the laparoscopic procedure in patients with locally advanced gastric cancer (AGC).
Retrospective studies have assessed the technical and oncological safety of LAG with D2 lymph node dissection for AGC(Hao Y et al .,2016).Recently, results of two ongoing randomized controlled trials (RCTs) have revealed the surgical safety of laparoscopic distal gastrectomy with D2 lymphadenectomy for AGC .
However, laparoscopic gastrectomy for locally advanced disease remains controversial(Hu Y et al.,2016).Here, we report the short-term surgical outcomes of a RCT comparing laparoscopic and open gastrectomy (OG) with D2 lymph node dissection for EGC, which was designed to assess the technical safety and oncologic feasibility of LAG for EGC.
Eligibility Criteria
Inclusion Criteria:The study included patients complaining of gastric cancer stage (T1-T2N0M0).The study will start from december 2022 .Inclusion criteria: Inclusion criteria were as follows: histologically confirmed adenocarcinoma of the stomach; pathologically confirmed stage T1-T2; no evidence of distant metastasis by means of abdominal computed tomography(CECT) and CT chest ; D2 lymphadenectomy with curative R0according to pathological diagnosis after the operation .
patients with N1 confirmed pathologically after operation also will be included in the study.Exclusion Criteria:pregnancyan American Society of Anesthesiologists (ASA) score > 3,severe mental disordersprior upper abdominal surgery except laparoscopic cholecystectomy,presence of other malignanciesa history of chemotherapy or radiation therapy.unstable angina or myocardial infarction within the past 6 months, severe respiratory disease (forced expiratory volume in 1 s, FEV1 < 50%)abdominal wall herniadiaphragmatic herniacoagulation disorderportal hypertensionAdvanced gastric cancer (stage;T3,T4,N1 to 3 ,M1) based on preoperative diagnosis.
Source: ClinicalTrials.gov (NCT05707338). StuddyBuddy aggregates publicly available trial information.