Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

NCT ID: NCT05537129

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2027-10-01

Brief Summary

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

Detailed 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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic Total Gastrectomy

Group Type: EXPERIMENTAL

Total Gastrectomy

Intervention Type: PROCEDURE

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

Open Total Gastrectomy

Group Type: ACTIVE_COMPARATOR

Total Gastrectomy

Intervention Type: PROCEDURE

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

Interventions

Total Gastrectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Dazhi Xu

PHD,MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dazhi Xu, PHD,MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dazhi Xu, PHD, MD

Role: CONTACT

xudzh@shca.org.cn

021-64175590

Facility Contacts

Dazhi Xu, PHD，MD

Role: primary

xudzh@shca.org.cn

021-64175590

Other Identifiers

LOTGGC

Identifier Type: -

Identifier Source: org_study_id