Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

Gastric Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05537129
• Other study ID #: LOTGGC
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2027

Study information

• Verified date: September 2022
• Source: Fudan University
• Contact: Dazhi Xu, PHD, MD
• Phone: 021-64175590
• Email: xudzh[@]shca.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)

2. age between 20 and 80 years old

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

4. 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)

5. 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

6. written informed consent

7. without preoperative chemotherapy and radiotherapy

Exclusion Criteria:

1. clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System

2. history of chemotherapy, radiotherapy, immunotherapy or target therapy

3. perigastric lymphnode=3cm

4. received gastric surgery (i.e. gastrectomy or gastrojejunostomy)

5. multiple primary tumors

6. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.

7. patients need emergency operation with complication of gastric cancer

8. adhesion due to the previous intraabdominal surgery

9. need for combined organ resection due to aggression of gastric cancer of other disease,

10. vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)

11. currently participating or participated in other clinical trials in the last 6 months

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 year-DFS	3 year-disease free survival	3 year
Secondary	3 year-OS	3 year-overall survival	3 year
Secondary	morbidity and mortality rates	morbidity and mortality within 30 days following surgeries	30 days following surgeries