Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Comparison of Laparoscopic Versus Open Distal Gastrectomy for T4a Gastric Cancer: a Prospective Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384757
• Other study ID #: UMC-UPPERGI-01
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: University Medical Center Ho Chi Minh City (UMC)
• Contact: Long D. Vo, PhD, MD
• Phone: +84918133915
• Email: long.vd[@]umc.edu.vn; longvoduy26[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage

Description:

Gastric cancer poses a significant public health problem. It is one of the most common cancers in Vietnam . Despite recent advances in multimodality treatment and targeted therapy, surgery remains the first option of treament for this disease. For resectable gastric cancer, complete removal of macroscopic and microscopic lesions and/or combined resections and also regional or extended lymphadenectomy should represent in the world now. Since laparoscopic gastrectomy for early gastric cancer (EGC) was firstly reported in 1994 , this technique has become standard for treatment of EGC due to the many advantages of mininally invasive surgery and also in oncologic outcomes.

Laparoscopic gastrectomy for advanced gastric cancer AGC was first applied by Uyama in 2000, and then, many surgeons have used it for treatment of AGC, especially in Japan, Korea and China. However, the real role of laparoscop for treament of (AGC) is still controversial in term of technical feasibility, safety and oncologic aspect.

Paragastric inflammatory strands may occur in T4a tumor so that laparoscopic technique is difficult to radically perform. Peritoneal seeding of malignant cells, intra- and postoperative complications, trocarts metastasis may risk during procedures. Despite, some studies have demonstrated the safety and the short-term benefits of LG for T4a gastric cancer, the number of these studies and sample sizes have been still inadequate to give good evidence for applying it. and long-term oncologic outcomes

There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• 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 located at the middle or lower third of the stomach

• Preoperative cancer stage (CT scan stage): cT4aN0M0, cT4aN1M0, cT4aN2M0, cT4aN3M0

• 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

• Had another treatment methods, such as chemotherapy, immunotherapy, or radiotherapy

• Pregnant patient

• Combined resection

• Total gastrectomy

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Distal gastrectomy
Distal gastrectomy and standard D2 lymphadenectomy

Locations

Country	Name	City	State
Vietnam	University Medical Center	Ho Chi Minh City	Ho Chi Minh

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	hospital stay	The number of days between surgery and discharge	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