Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer

Stomach Neoplasm Clinical Trial

Official title:

Prospective Randomized Controlled Trial for Comparison of Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03524300
• Other study ID #: FUGES-015
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2020
• Source: Fujian Medical University
• Contact: Changming Huang, Professor
• Phone: +86-138-0506-9676
• Email: hcmlr2002[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer

Description:

Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted total gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic assisted total gastrectomy in the treatment of clinical Stage I gastric adenocarcinoma （cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0））.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age from over 18 to under 75 years

• Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cStage IA(T1N0M0)or cStage IB(T1N1M0,T2N0M0)at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition

• The tumor is on the upper or middle third stomach and expected to perform total gastrectomy with D1+/D2-10 lymph node dissction to obtain R0 resection sugicall results.

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

• ASA (American Society of Anesthesiology) class I to III

• Written informed consent

Exclusion Criteria:

• cStage IIA or more advaned at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition

• Women during pregnancy or breast-feeding

• Severe mental disorder

• History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

• Multiple primary cancer

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

• Gastric multiple primary carcinoma

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

• History of other malignant disease within the past 5 years

• History of previous neoadjuvant chemotherapy or radiotherapy

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

• History of cerebrovascular accident within the past 6 months

• History of continuous systematic administration of corticosteroids within 1 month

• Requirement of simultaneous surgery for other disease

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

• FEV1<50% of the predicted values

Related Conditions & MeSH terms

• Robotic Surgery
• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Procedure:
• Robotic Assisted Total Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,robotic assisted total gastrectomy will be performed in the experimental group.
• Laparoscopic Assisted Total Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case,laparoscopic assisted total gastrectomy will be performed in the experimental group.

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	3-year disease free survival rate	the rate of 3-year disease free survival	36 months
Secondary	3-year overall survival rate	the rate of 3-year overall survival rate	36 months
Secondary	3-year recurrence pattern	the pattern of recurrence in 3 years	36 months
Secondary	overall postoperative morbidity rates	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.	30 days
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	Time to first ambulation	Time to first ambulation in hours is used to assess the postoperative recovery course.	30 days
Secondary	Time to first flatus	Time to first flatus in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first liquid diet	Time to first liquid diet in days is used to assess the postoperative recovery course	30 days
Secondary	Time to first soft diet	Time to first soft diet in days is used to assess the postoperative recovery course.	30 days
Secondary	Duration of postoperative hospital stay	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	30 days
Secondary	The variation of weight	The variation of weight in kilograms on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.	3, 6, 9 and 12 months
Secondary	The variation of white blood cell count	The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory response.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	Hospitalization expenses	The cost from admission to discharge	30 days
Secondary	operation time	operation time	1 day