Clinical trial NCT03313700: Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer
Official title: Randomized Controlled Trials on Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasm
Robotic Surgery
Keywords: Stomach Neoplasm
Robotic Surgery
Distal Gastrectomy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the clinical outcomes of the robotic distal gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.

Detailed 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 distal gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic distal gastrectomy in the treatment of gastric adenocarcinoma （cT1-4a, N-/+, M0）.

Eligibility criteria: 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 dissction to obtain R0 resection sugicall results.
5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) 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 ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )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. FEV1\<50% of the predicted values

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months
Secondary outcomes:
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: overall postoperative morbidity rates
timeFrame: 30 days
measure: intraoperative morbidity rates
timeFrame: 1 day
measure: overall postoperative serious morbidity rates
timeFrame: 30 days
measure: number of retrieved lymph nodes
timeFrame: 1 days
measure: the noncompliance rate of lymphadenectomy
timeFrame: 1 days
measure: Time to first ambulation
timeFrame: 30 days
measure: Time to first flatus
timeFrame: 30 days
measure: Time to first liquid diet
timeFrame: 30 days
measure: Time to first soft diet
timeFrame: 30 days
measure: Duration of postoperative hospital stay
timeFrame: 30 days
measure: The variation of weight
timeFrame: 3, 6, 9 and 12 months
measure: The variation of cholesterol
timeFrame: 3, 6, 9 and 12 months
measure: The variation of album
timeFrame: 3, 6, 9 and 12 months
measure: The variation of white blood cell count
timeFrame: Preoperative 7 days and postoperative 1 and 5 days
measure: The variation of hemoglobin
timeFrame: Preoperative 7 days and postoperative 1 and 5 days
measure: Hospitalization expenses
timeFrame: 30 days
measure: operation time
timeFrame: 1 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Changming Huang, Professor
role: PRINCIPAL_INVESTIGATOR
References: