Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer: a Propensity Score-matched Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05493358
• Other study ID #: 71/GCN-HÐÐÐ
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: University Medical Center Ho Chi Minh City (UMC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.

Description:

Gastric cancer 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 worldwide now.

Laparoscopic gastrectomy for locally advanced gastric cancer AGC have commonly used 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 for T4a stage.

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 was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients with histologically confirmed adenocarcinoma of the stomach, surgical staging of sT4aN0-3M0 according to the 7th edition of the American Joint Committee on Cancer/Union Internationale Contre le Cancer (AJCC/UICC) staging system

Exclusion Criteria:

• intraoperatively detected bulky lymph nodes

• inadequate lymphadenectomy (D0, D1, D1+)

• macroscopic residual tumor (R2)

• an American Society of Anaesthesiology (ASA) score of > IV

• concurrent cancer or history of previous other cancers

• previous gastrectomy

• neoadjuvant chemotherapy

• complications such as bleeding or perforation required emergency gastrectomy.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic distal gastrectomy
Distal gastrectomy and standard D2 lymphadenectomy

Locations

Country	Name	City	State
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	5 year overall survival by Kaplan Mayer	The percentage of people in this study who are alive five years after surgery.	5 year after surgery
Primary	5 year disease-free survival by Kaplan Mayer	The percentage of people in this study who are alive without recurrence/metastasis five years after surgery.	5 year after surgery
Secondary	1 year overall survival by Kaplan Mayer	The percentage of people in this study who are alive one years after surgery.	1 year after surgery
Secondary	3 year overall survival by Kaplan Mayer	The percentage of people in this study who are alive one years after surgery.	3 year after surgery
Secondary	1 year disease-free survival by Kaplan Mayer	The percentage of people in this study who are alive without recurrence/metastasis one years after surgery.	1 year after surgery
Secondary	3 year disease-free survival by Kaplan Mayer	The percentage of people in this study who are alive without recurrence/metastasis one years after surgery.	3 year after surgery
Secondary	operative morbidity	The overall rate of postoperative complications	30 days after surgery
Secondary	operative time	The duration of a surgical procedure in minutes.	intraoperative
Secondary	operative blood loss	The amount of blood lost during procedure	intraoperative
Secondary	time to flatus	Number of days from date of surgery until date of flatus	30 days after surgery or until mortality ]
Secondary	Postoperative hospital length of stay	Number of days from date of surgery until date of discharge or mortality	30 days after surgery or until mortality
Secondary	The percentage of complications with Clavien-Dindo	The percentage of complication grade by Clavien-Dindo classification	30 days after surgery
Secondary	The percentage of pattern of recurrence/metastasis	The percentage of pattern of recurrence/metastasis during follow up period	5 year after surgery