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

NCT ID: NCT05493358

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 472 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2022-06-30

Brief 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.

Detailed 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.

Conditions

Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Open distal gastrectomy

An incision of 15\~20 cm length is made in the abdominal midline . Standard distal gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, proper hepatic artery) . As a general rule, Billroth I, Billroth II or Roux en Y method was used for gastric reconstruction.

No interventions assigned to this group

Laparoscopic distal gastrectomy

5 trocar 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 the right gastroepiploic and the inferior pyloric artery were vascularized and cut at their origin from the gastroduodenal artery, just above the pancreatic head, 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 prepared and separately divided and then the left gastric artery was vascularized to remove group 7.

The dissection was continued upward along the proximal branches of splenic vessels to remove group 11p and along the lesser curvature to remove group 1,3.

As a general rule, Billroth I, Billroth II or Roux en Y method was used for gastric reconstruction.

Laparoscopic distal gastrectomy

Intervention Type: PROCEDURE

Distal gastrectomy and standard D2 lymphadenectomy

Interventions

Laparoscopic distal gastrectomy

Distal gastrectomy and standard D2 lymphadenectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Ho Chi Minh City (UMC)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Long D. Vo, MD PhD.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center HCMC, Vietnam

Locations

University Medical Center Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Other Identifiers

71/GCN-HĐĐĐ

Identifier Type: -

Identifier Source: org_study_id