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Clinical Trials/NCT03313700
NCT03313700CompletedNot Applicable

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

Fujian Medical University1 site in 1 country300 target enrollmentStarted: September 25, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
3-year disease free survival rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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）.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •cT1-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  • •expected to perform distal gastrectomy with D1+/D2 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

  • •Women during pregnancy or breast-feeding
  • •Severe mental disorder
  • •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • •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

Outcomes

Primary Outcomes

3-year disease free survival rate

Time Frame: 36 months

the rate of 3-year disease free survival

Secondary Outcomes

  • 3-year overall survival rate(36 months)
  • 3-year recurrence pattern(36 months)
  • overall postoperative morbidity rates(30 days)
  • intraoperative morbidity rates(1 day)
  • overall postoperative serious morbidity rates(30 days)
  • number of retrieved lymph nodes(1 days)
  • Time to first flatus(30 days)
  • Time to first soft diet(30 days)
  • Duration of postoperative hospital stay(30 days)
  • The variation of white blood cell count(Preoperative 7 days and postoperative 1 and 5 days)
  • the noncompliance rate of lymphadenectomy(1 days)
  • Time to first ambulation(30 days)
  • Time to first liquid diet(30 days)
  • The variation of weight(3, 6, 9 and 12 months)
  • The variation of cholesterol(3, 6, 9 and 12 months)
  • The variation of album(3, 6, 9 and 12 months)
  • The variation of hemoglobin(Preoperative 7 days and postoperative 1 and 5 days)
  • Hospitalization expenses(30 days)
  • operation time(1 days)

Investigators

Sponsor
Fujian Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chang-Ming Huang, Prof.

Director, Head of gastric surgery, Principal Investigator, Clinical Professor

Fujian Medical University

Study Sites (1)

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