Comparison of Laparoscopic and Open Total Gastrectomy for Locally Advanced Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic gastrectomy.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Laparoscopic Versus Open Total Gastrectomy for Locally Advanced Gastric Cancer: a Prospective Randomized Control Trial
Overview
Evidence of implementation of laparoscopic total gastrectomy (LTG) for locally advanced gastric cancer (GC) remains inadequate. This study aimed to compare short- and mid-term outcomes of LTG versus open total gastrectomy (OTG) for cT2-4a GC.
Detailed description
Gastric cancer (GC) is a significant public health issue worldwide. Surgical resection and lymphadenectomy is the first option for curative treatment of this disease. For tumors located in the middle and/or upper third of the stomach, open total gastrectomy (OTG) has long been the standard surgery.
While the advantage of laparoscopic distal gastrectomy over open distal gastrectomy for not only early gastric cancer (EGC) but also locally advanced gastric cancer (AGC) had been proven, the use of laparoscopic total gastrectomy (LTG) for GC, particularly for AGC, has not been widely accepted due to technical challenges with lymphadenectomy at the distal pancreas and the splenic hilum as well as the complexity of the esophago-jejunal reconstruction. Recently, there has been advancement in laparoscopic techniques and improved surgical experience, a standard procedure of LTG has been established, leading to increase utilization of LTG, especially for EGC. Two large RCTs, KLASS-03 in Korea and CLASS-02 in China, provided good evidence for the advantages of LTG for EGC. However, for AGC, some prior studies have demonstrated the safety of LTG compared to OTG but lacked significant data for survival. Until now, there have been no completed RCTs to determine the short- and long-term outcomes of LTG for AGC.
In the research center, LTG has been accepted as a standard procedure for EGC since 2008 and for AGC since 2013. In Vietnam and other low-to-middle-income countries, most GC was diagnosed in an advanced stage. It is needed to have evidence of the feasibility, safety, and oncological results of LTG for locally advanced GC. Investigators performed this study to compare the technical feasibility, short- and long-term outcomes of LTG versus OTG for stage T2-4a GC.
Interventions
- Procedure Laparoscopic gastrectomy
Gastrectomy with laparoscopic approach
Primary outcome measures
- 3 year overall survival by Kaplan Mayer [Time frame: 3 year after surgery]
- 3 year relapse-free survival by Kaplan Mayer [Time frame: 3 year after surgery]
Secondary outcome measures (5)
- operative morbidity [Time frame: 30 days after surgery]
- operative mortality [Time frame: 30 days after surgery]
- operative time [Time frame: intraoperative]
- Resected lymph nodes [Time frame: intraoperative]
- hospital stay [Time frame: 30 days after surgery]
Eligibility criteria
Inclusion criteria
- Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
- Age: 18 - 80 year old
- Tumor required total gastrectomy for radical treatment
- Preoperative cancer stage (CT scan stage): cT2-4aNanyM0
- ASA score: ≤ 3
- Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)
Exclusion criteria
- Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer
- Bulky lymph node andd/or Para-aortic lymph node metastasis
- Combined esophagectomy due to invading to the esophagus
- Pregnant patient
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Vietnam · 3 centers
- Dong Nai General Hospital — Bien Hoa
- 108 Military Central Hospital — Hà Nội
- University Medical Center Ho Chi Minh City — Ho Chi Minh City
Identifiers
NCT: NCT06202105 · LOTA