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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Laparoscopic gastrectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ha Noi, Vietnam, 100000
    • Not yet recruiting
    • 108 Military Central Hospital
    • Contact: Pham Van Hiep, Ph.D; Email: drphamvanhiep108@gmail.com
  • Ho Chi Minh City, Vietnam, 700000
    • Recruiting
    • University Medical Center Ho Chi Minh city
    • Contact: L D.
    • Contact: Long D. Vo, MD.; Phone Number: +84918133915; Email: long.vd@umc.edu.vn
  • Dong Nai
    • Bien Hoa, Dong Nai, Vietnam, 810000
      • Recruiting
      • Dong Nai General Hospital
      • Contact: Nguyen Kim Kien; Phone Number: 0938770667; Email: bsnguyenkimkien@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic total gastrectomy; 5 trocars were used. The gastrocolic ligament was divided along the border of the transverse colon. ligating the left gastroepiploic vessels to remove group 4sb. The right gastroepiploic vein was divided and right gastroepiploic and inferior pyloric artery were transected at their origin from the gastroduodenal artery to dissect group 6. The dissection was continued along the hepatoduodenal ligament to removed group 5 and group 12a and along the common hepatic artery to remove group 8a and along the celiac axis to remove group 9. The left gastric vein was divided and then the left gastric artery was vascularized to remove group 7. The dissection was continued upward along the splenic artery and its branches to remove group 11p,d and/or along the splenic hilum to remove group 10. The dissection was then conducted the right and left of the esophago-gastric junction to remove group 1,2. As a general rule, Roux en Y method was used for esophagoo-jejunal reconstruction for all cases	Procedure: Laparoscopic gastrectomy; Gastrectomy with laparoscopic approach
Active Comparator: Open total gastrectomy; An incision of 15~20 cm length is made in the abdominal midline . Standard total gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, along splenic artery, proper hepatic artery, and/or the splenic hilum) . Roux-en Y esophagojejunal anastomosis is performed for reconstruction.	Procedure: Laparoscopic gastrectomy; Gastrectomy with laparoscopic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative morbidity	The rate of postoperative bleeding and the rate of postoperative leakage	30 days after surgery
operative mortality	The rate of postoperative dead	30 days after surgery
hospital stay	The number of days between surgery and discharge	30 days after surgery
operative time	The duration of a surgical procedure in minutes.	intraoperative
Resected lymph nodes	The number of lymph nodes harvested after surgery	intraoperative

Collaborators and Investigators

• Sponsor: University Medical Center Ho Chi Minh City (UMC)

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2024
• Primary Completion (Estimated): August 2, 2032
• Study Completion (Estimated): August 2, 2032

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: LOTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No