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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Medical Center Ho Chi Minh City (UMC)

About this trial

Evidence of implementation of laparoscopic total gastrectomy (LTG) for locally advanced gastric cancer (GC) remains inadequate. This study aimed to compare short- and mid-term outcomes of LTG versus open total gastrectomy (OTG) for cT2-4a GC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma

Age: 18 - 80 year old

Tumor required total gastrectomy for radical treatment

Preoperative cancer stage (CT scan stage): cT2-4aNanyM0

Disqualifiers

Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer

Bulky lymph node andd/or Para-aortic lymph node metastasis

Combined esophagectomy due to invading to the esophagus

Pregnant patient

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic gastrectomy

    Procedure/Surgery

    Gastrectomy with laparoscopic approach

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Laparoscopic total gastrectomyExperimental treatment 1 intervention
Group B: Open total gastrectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

3 year overall survival by Kaplan Mayer

The percentage of people in this study who are alive three years after surgery

Time frame
3 year after surgery
2

3 year relapse-free survival by Kaplan Mayer

The percentage of people in this study who are alive without recurrence three years after surgery.

Time frame
3 year after surgery

Secondary outcomes

1

operative morbidity

The rate of postoperative bleeding and the rate of postoperative leakage

Time frame
30 days after surgery
2

operative mortality

The rate of postoperative dead

Time frame
30 days after surgery
3

operative time

The duration of a surgical procedure in minutes.

Time frame
intraoperative
4

Resected lymph nodes

The number of lymph nodes harvested after surgery

Time frame
intraoperative

Other outcomes

Sponsors and contacts

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