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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03524300
Other study ID # FUGES-015
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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