Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

• Sponsor: Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05537129
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Procedure: Total Gastrectomy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laparoscopic Total Gastrectomy	Procedure: Total Gastrectomy; The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.
Active Comparator: Open Total Gastrectomy	Procedure: Total Gastrectomy; The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.

Outcome Measures

Primary Outcome Measures

1. 3 year-DFS [3 year]

   3 year-disease free survival

Secondary Outcome Measures

1. 3 year-OS [3 year]

   3 year-overall survival

2. morbidity and mortality rates [30 days following surgeries]

   morbidity and mortality within 30 days following surgeries

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China

Sponsors and Collaborators

• Fudan University

Investigators

• Principal Investigator: Dazhi Xu, PHD,MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dazhi Xu, PHD,MD, Fudan University
• ClinicalTrials.gov Identifier: NCT05537129
• Other Study ID Numbers: LOTGGC
• First Posted: Sep 13, 2022
• Last Update Posted: Sep 13, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dazhi Xu, PHD,MD, Fudan University: Gastric cancer, Laparoscopic Total Gastrectomy, Open Total Gastrectomy
• Additional relevant MeSH terms: Stomach Neoplasms

Study Results

No Results Posted as of Sep 13, 2022