Comparison of Laparoscopic and Open Total Gastrectomy for Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

— LOTA  

Official title:

Comparison of Laparoscopic Versus Open Total Gastrectomy for Locally Advanced Gastric Cancer: a Prospective Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06202105
• Other study ID #: LOTA
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: June 1, 2029

Study information

• Verified date: December 2023
• Source: University Medical Center Ho Chi Minh City (UMC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: June 1, 2029
• Est. primary completion date: January 2, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic gastrectomy
Gastrectomy with laparoscopic approach

Locations

Country	Name	City	State
Vietnam	Dong Nai General Hospital	Bien Hoa	Dong Nai
Vietnam	108 Military Central Hospital	Ha Noi
Vietnam	University Medical Center Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Ho Chi Minh City (UMC)

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 year overall survival by Kaplan Mayer	The percentage of people in this study who are alive three years after surgery	3 year after surgery
Primary	3 year relapse-free survival by Kaplan Mayer	The percentage of people in this study who are alive without recurrence three years after surgery.	3 year after surgery
Secondary	operative morbidity	The rate of postoperative bleeding and the rate of postoperative leakage	30 days after surgery
Secondary	operative mortality	The rate of postoperative dead	30 days after surgery
Secondary	operative time	The duration of a surgical procedure in minutes.	intraoperative
Secondary	Resected lymph nodes	The number of lymph nodes harvested after surgery	intraoperative
Secondary	hospital stay	The number of days between surgery and discharge	30 days after surgery