Short-term Outcomes of Laparoscopic Versus Open Gastrectomy With Lymph Node Dissection for Early Gastric Cancer :a Randomized Controlled Study

Trial Title: Short-term Outcomes of Laparoscopic Versus Open Gastrectomy With Lymph Node Dissection for Early Gastric Cancer :a Randomized Controlled Study

NCT ID: NCT05707338

Condition: Early Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Gastrectomy with lymph node dissection
Description: prospective randomized comparative clinical trial study analyzing outcomes of gastrectomy for early gastric cancer using laporoscopy versus open approach. This will be a prospective comparative study at Sohag University Hospital, Egypt and National Cancer Institute(NCI), Cairo university ,Egypt. Patients were divided randomizly into two groups; the first group included patients who will have laparoscopic gastrectomy (Lap group), and the second group included patients will receive open gastrectomy (Open group).
Arm group label: laparoscopic group
Arm group label: open group

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.

Detailed description: Aim of the work a prospective randomized controlled trial comparing laparoscopic and open gastrectomy with D2 lymph node dissection for EGC to evaluate technical safety and oncologic feasibility. The postoperative morbidity and mortality rates will be based on the modified intention-to-treat analysis. The aim of this study is to compare the operative and short-term oncologic outcomes of laparoscopic versus open resections. Patients and methods The study design: : prospective randomized comparative clinical trial study analyzing outcomes of gastrectomy for early gastric cancer using laporoscopy versus open approach. This will be a prospective comparative study at Sohag University Hospital, Egypt and National Cancer Institute(NCI), Cairo university ,Egypt. Patients were divided randomizly into two groups; the first group included patients who will have laparoscopic gastrectomy (Lap group), and the second group included patients will receive open gastrectomy (Open group). Study population 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 R0 according to pathological diagnosis after the operation . patients with N1 confirmed pathologically after operation also will be included in the study. The exclusion criteria: 1. pregnancy 2. an American Society of Anesthesiologists (ASA) score > 3, 3. severe mental disorders 4. prior upper abdominal surgery except laparoscopic cholecystectomy, 5. presence of other malignancies 6. a history of chemotherapy or radiation therapy. 7. unstable angina or myocardial infarction within the past 6 months, severe respiratory disease (forced expiratory volume in 1 s, FEV1 < 50%) 8. abdominal wall hernia 9. diaphragmatic hernia 10. coagulation disorder 11. portal hypertension 12. Advanced gastric cancer (stage;T3,T4,N1 to 3 ,M1) based on preoperative diagnosis. Approvals and consents This study will be done after obtaining approval from the research ethics committee of the Sohag faculty of medicine. A written Informed consent will be obtained from all participants before being enrolled in the study and before performing the procedure after receiving an explanation of the study protocol, including both types of operation and possible complications. The study will be registered at www.clinicaltrials.gov. Data collection: Registered data will be collected from the hospital databases, clinical data. Randomization Randomization was performed by closed envelopes and was balanced and stratified for proposed type of resection.

Criteria for 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 R0 according to pathological diagnosis after the operation . patients with N1 confirmed pathologically after operation also will be included in the study. Exclusion Criteria: 1. pregnancy 2. an American Society of Anesthesiologists (ASA) score > 3, 3. severe mental disorders 4. prior upper abdominal surgery except laparoscopic cholecystectomy, 5. presence of other malignancies 6. a history of chemotherapy or radiation therapy. 7. unstable angina or myocardial infarction within the past 6 months, severe respiratory disease (forced expiratory volume in 1 s, FEV1 < 50%) 8. abdominal wall hernia 9. diaphragmatic hernia 10. coagulation disorder 11. portal hypertension 12. Advanced gastric cancer (stage;T3,T4,N1 to 3 ,M1) based on preoperative diagnosis.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Start date: February 2023

Completion date: January 2025

Lead sponsor:
Agency: Sohag University
Agency class: Other

Source: Sohag University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05707338