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

NCT05493358 | Completed

• 1 other identifier: 71/GCN-HĐĐĐ
• Study Type: observational
• Target: 472
• 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 was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (11)

• 1 year overall survival by Kaplan Mayer

  1 year after surgery

• 3 year overall survival by Kaplan Mayer

  3 year after surgery

• 1 year disease-free survival by Kaplan Mayer

  1 year after surgery

• 3 year disease-free survival by Kaplan Mayer

  3 year after surgery

• operative morbidity

  30 days after surgery

Study Arms (2)

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.

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.

Procedure: Laparoscopic distal gastrectomy

Interventions

Laparoscopic distal gastrectomy PROCEDURE

Distal gastrectomy and standard D2 lymphadenectomy

Laparoscopic distal gastrectomy

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients with surgical T4a (sT4a) gastric adenocarcinoma at the lower or middle third of the stomach who underwent ODG or LDG plus lymphadenectomy between January 2013 and December 2020 at the Gastro-intestinal Surgical Department of the University Medical Center at Ho Chi Minh City, Vietnam

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Long D. Vo, MD PhD.

  University Medical Center HCMC, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 9, 2022
• Study Start: January 1, 2013
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2022
• Last Updated: May 6, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)