Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

NCT04384757 | Active Not Recruiting DMC

• 1 other identifier: UMC-UPPERGI-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer

Keywords

gastric cancer; laparoscopic gastrectomy; T4a stage

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• operative morbidity

  30 days after surgery

• operative mortality

  30 days after surgery

• hospital stay

  30 days after surgery

• operative time

  intraoperative

• Resected lymph nodes

  intraoperative

Study Arms (2)

Open distal gastrectomy

ACTIVE COMPARATOR

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

Procedure: Distal gastrectomy

Laparoscopic distal gastrectomy

EXPERIMENTAL

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

Procedure: Distal gastrectomy

Interventions

Distal gastrectomy PROCEDURE

Distal gastrectomy and standard D2 lymphadenectomy

Laparoscopic distal gastrectomy; Open distal gastrectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead

Study Sites (1)

University Medical Center

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

Location

Related Publications (2)

• Dat TQ, Thong DQ, Nguyen DT, Hai NV, Phuoc TD, Anh NVT, Bac NH, Long VD. Laparoscopic vs Open Distal Gastrectomy With D2 Lymphadenectomy for Clinical T4a Gastric Cancer: The UMC-UPPERGI-01 Randomized Clinical Trial. JAMA Surg. 2026 Jan 1;161(1):9-18. doi: 10.1001/jamasurg.2025.4929.

  PMID: 41222957 DERIVED

• 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.

  PMID: 40316937 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastroenterostomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Long D. Vo, PhD, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of GI Surgery Department

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 12, 2020
• Study Start: July 29, 2020
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

VN (1)