Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04795063
• Other study ID #: FUGES-022
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2021
• Source: Fujian Medical University
• Contact: Chang-ming Huang, MD
• Phone: +86-13805069676
• Email: hcmlr2002[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).

Description:

In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for GC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age from over 18 to under 75 years

2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy

3. cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition

4. expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.

5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale

6. American Society of Anesthesiology (ASA) class I to III

7. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding

2. Severe mental disorder

3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

4. History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)

5. Gastric multiple primary carcinoma

6. Enlarged or bulky regional lymph node (diameter over 3cm)supported by preoperative imaging

7. History of other malignant disease within the past 5 years

8. History of previous neoadjuvant chemotherapy or radiotherapy

9. History of unstable angina or myocardial infarction within the past 6 months

10. History of cerebrovascular accident within the past 6 months

11. History of continuous systematic administration of corticosteroids within 1 month

12. Requirement of simultaneous surgery for other disease

13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

14. Forced expiratory volume in 1 second (FEV1)<50% of the predicted values

Related Conditions & MeSH terms

• Gastric Cancer
• Robotic Gastrectomy
• Stomach Neoplasms

Intervention

Procedure:
• Total Robotic Distal Gastrectomy
All the surgical procedures are performed using the robot system.
• Robotic-Assisted Distal Gastrectomy
After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity rates	This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.	30 days
Secondary	3-year disease free survival rate	3-year disease free survival rate	36 months
Secondary	3-year overall survival rate	3-year overall survival rate	36 months
Secondary	3-year recurrence pattern	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.	36 months
Secondary	intraoperative morbidity rates	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.	1 day
Secondary	overall postoperative serious morbidity rates	Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher	30 days
Secondary	Total Number of Retrieved Lymph Nodes	Total Number of Retrieved Lymph Nodes	1 day
Secondary	postoperative recovery course	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	30 days
Secondary	postoperative nutritional status	The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.	3, 6, 9 and 12 months
Secondary	inflammatory immune response	The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	Time of digestive tract reconstruction	From the beginning to the end of digestive tract reconstruction	1 day