Laparoscopic Gastrectomy
ProcedureGastrectomy with laparoscopic approach
NCT Number: NCT06202105
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Dong Nai General Hospital, Bien Hoa, Dong Nai, Vietnam
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gastrectomy with laparoscopic approach
Time frame: 3 year after surgery
The percentage of people in this study who are alive three years after surgery
Time frame: 3 year after surgery
The percentage of people in this study who are alive without recurrence three years after surgery.
Time frame: 30 days after surgery
The rate of postoperative bleeding and the rate of postoperative leakage
Time frame: 30 days after surgery
The rate of postoperative dead
Time frame: intraoperative
The duration of a surgical procedure in minutes.
Time frame: intraoperative
The number of lymph nodes harvested after surgery
Time frame: 30 days after surgery
The number of days between surgery and discharge
University Medical Center Ho Chi Minh City (UMC)
Other
Comparison of Laparoscopic Versus Open Total Gastrectomy for Locally Advanced Gastric Cancer: a Prospective Randomized Control Trial
Acronym: LOTA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04557969
Digestive System Diseases, Digestive System Neoplasms
Bethesda, Maryland, United States
View Trial DetailsNCT06417892
Digestive System Diseases, Digestive System Neoplasms
Beijing, Beijing Municipality, China
View Trial DetailsNCT07066657
Colonic Diseases, Colorectal Cancer
Los Angeles, California, United States
View Trial DetailsNCT06910657
Adenocarcinoma, Adnexal Diseases
St Louis, Missouri, United States
View Trial Details