Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-12-30
Brief Title:
Comparison of Laparoscopic and Open Total Gastrectomy for Locally Advanced Gastric Cancer
Sponsor:
University Medical Center Ho Chi Minh City UMC
Organization:
University Medical Center Ho Chi Minh City UMC
Study Overview
Official Title:
Comparison of Laparoscopic Versus Open Total Gastrectomy for Locally Advanced Gastric Cancer a Prospective Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOTA
Brief Summary:
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 andor 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 our 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 We performed this study to compare the technical feasibility short- and long-term outcomes of LTG versus OTG for stage T2-4a GC
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 our 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 We performed this study to compare the technical feasibility short- and long-term outcomes of LTG versus OTG for stage T2-4a GC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None