Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

NCT ID: NCT04384757

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-29
• Study Completion Date: 2028-06-30

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 is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage

Detailed 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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

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 II method was used for gastric reconstruction for most cases

Group Type: ACTIVE_COMPARATOR

Distal gastrectomy

Intervention Type: PROCEDURE

Distal gastrectomy and standard D2 lymphadenectomy

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 II method was used for gastric reconstruction for most cases

Group Type: EXPERIMENTAL

Distal gastrectomy

Intervention Type: PROCEDURE

Distal gastrectomy and standard D2 lymphadenectomy

Interventions

Distal gastrectomy

Distal gastrectomy and standard D2 lymphadenectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Ho Chi Minh City (UMC)

OTHER

Sponsor Role: lead

Responsible Party

VoDuy Long

Deputy Head of GI Surgery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Long D. Vo, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center, 215 Hong Bang street, Dist. 5, HCM city, VN

Locations

University Medical Center

Ho Chi Minh City, Ho Chi Minh, Vietnam

Countries

Vietnam

References

Dat TQ, Thong DQ, Nguyen DT, Hai NV, Vuong NL, Bac NH, Long VD. Laparoscopic versus open distal gastrectomy with d2 lymphadenectomy in treatment of locally T4A gastric cancer: the protocol of a randomized controlled trial. BMC Surg. 2025 May 2;25(1):193. doi: 10.1186/s12893-025-02933-6.

Reference Type: DERIVED

PMID: 40316937 (View on PubMed)

Other Identifiers

UMC-UPPERGI-01

Identifier Type: -

Identifier Source: org_study_id