Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05537129

Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Dazhi Xu, PHD，MD

CONTACT

[email protected]

021-64175590

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total gastrectomy

Procedure

The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.

Primary outcomes

  1. 3 year-DFS

    Time frame: 3 year

    3 year-disease free survival

Secondary outcomes

  1. 3 year-OS

    Time frame: 3 year

    3 year-overall survival

  2. morbidity and mortality rates

    Time frame: 30 days following surgeries

    morbidity and mortality within 30 days following surgeries

Study contacts

Contact information is provided by the study sponsor or research team.

Dazhi Xu, PHD, MD

CONTACT

[email protected]

021-64175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Sep 13, 2022
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.