Clinical trial NCT06202105: Comparison of Laparoscopic and Open Total Gastrectomy for Locally Advanced Gastric Cancer
Official title: Comparison of Laparoscopic Versus Open Total Gastrectomy for Locally Advanced Gastric Cancer: a Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: 3 year overall survival by Kaplan Mayer
timeFrame: 3 year after surgery
measure: 3 year relapse-free survival by Kaplan Mayer
timeFrame: 3 year after surgery
Secondary outcomes:
measure: operative morbidity
timeFrame: 30 days after surgery
measure: operative mortality
timeFrame: 30 days after surgery
measure: operative time
timeFrame: intraoperative
measure: Resected lymph nodes
timeFrame: intraoperative
measure: hospital stay
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Bien Hoa
country: Vietnam
facility: Dong Nai General Hospital
state: Dong Nai
city: Ha Noi
country: Vietnam
facility: 108 Military Central Hospital
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
References: