Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

Fudan University

Status

Enrolling

Conditions

Gastric Cancer

Treatments

Procedure: Total Gastrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05537129

LOTGGC

Details and patient eligibility

About

The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.

Full description

Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. With an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. However, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.

Enrollment

600 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
age between 20 and 80 years old
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese
written informed consent
without preoperative chemotherapy and radiotherapy

Exclusion criteria

clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
history of chemotherapy, radiotherapy, immunotherapy or target therapy
perigastric lymphnode≥3cm
received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
multiple primary tumors
suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
patients need emergency operation with complication of gastric cancer
adhesion due to the previous intraabdominal surgery
need for combined organ resection due to aggression of gastric cancer of other disease,
vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)
currently participating or participated in other clinical trials in the last 6 months