Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06202105

Comparison of Laparoscopic Versus Open Total Gastrectomy for Locally Advanced Gastric Cancer A Prospective Randomized Controlled Trial

Led by University Medical Center Ho Chi Minh City (UMC) · Updated on 2025-01-01

210

Participants Needed

3

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Gastric cancer is a serious health problem worldwide, and surgery is the main treatment option for cure. This research focuses on comparing two surgical methods for treating locally advanced gastric cancer that requires total gastrectomy. While open total gastrectomy (OTG) has been the standard, laparoscopic total gastrectomy (LTG) is being studied for its safety, feasibility, and long-term outcomes, especially since previous trials mainly addressed early-stage cancer and not advanced disease. The study is a prospective randomized controlled trial conducted in settings where many patients are diagnosed at advanced stages and aims to provide evidence on LTG's benefits and risks compared to OTG. Participants receive either laparoscopic gastrectomy or open total gastrectomy for tumors classified as stage cT2-4a without distant metastasis. The laparoscopic procedure uses a minimally invasive approach, while the open surgery follows traditional methods. The study evaluates both short- and mid-term outcomes after surgery, including survival and relapse rates. The surgical experience and technical advances have allowed LTG to become more common, but this trial aims to clarify its role for advanced cases. Participants are monitored over a three-year period to assess overall survival and relapse-free survival after surgery. Researchers will collect data on surgical safety, recovery, and cancer outcomes. Patients must meet specific health criteria and agree to participate with informed consent. This follow-up includes regular imaging and clinical evaluations to track the progress and detect any cancer recurrence or complications, providing important insight into the effectiveness of laparoscopic versus open surgery for gastric cancer.

CONDITIONS

Official Title

Comparison of Laparoscopic and Open Total Gastrectomy for Locally Advanced Gastric Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed gastric adenocarcinoma by gastric endoscopy
  • Age between 18 and 80 years old
  • Tumor requiring total gastrectomy for radical treatment
  • Preoperative cancer stage cT2-4aNanyM0 by CT scan
  • ASA score of 3 or less
  • Provided informed consent for participation
Not Eligible

You will not qualify if you...

  • Having another current cancer or previous cancer treatment before gastric cancer diagnosis
  • Presence of bulky lymph nodes or para-aortic lymph node metastasis
  • Need for combined esophagectomy due to tumor invasion of the esophagus
  • Being pregnant

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Dong Nai General Hospital

Bien Hoa, Dong Nai, Vietnam, 810000

Actively Recruiting

2

108 Military Central Hospital

Hà Nội, Vietnam, 100000

Not Yet Recruiting

3

University Medical Center Ho Chi Minh City

Ho Chi Minh City, Vietnam, 700000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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