Clinical trial NCT03006263: Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer
Official title: Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Stomach Neoplasms
Totally Laparoscopic Total Gastrectomy
Laparoscopy Assisted Total Gastrectomy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 110
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 clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 to 75 years old
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
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. Pregnant and lactating women
2. Suffering from severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
6. History of other malignant disease within the past 5 years
7. History of previous neoadjuvant chemotherapy or radiotherapy
8. History of unstable angina or myocardial infarction within the past 6 months
9. History of cerebrovascular accident within the past 6 months
10. History of continuous systematic administration of corticosteroids within 1 month
11. Requirement of simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
13. FEV1\<50% of the predicted values

Primary outcomes:
measure: overall postoperative morbidity rates
timeFrame: 30 days
Secondary outcomes:
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Intraoperative morbidity rates
timeFrame: 1 day
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: Postoperative pain
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 results of endoscopy
timeFrame: 3 and 12 months
measure: The variation of body temperature
timeFrame: 8 days
measure: The variation of white blood cell count
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The variation of hemoglobin
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The variation of C-reactive protein
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Fujian Medical University Union Hospital,China
name: Changming Huang, Professor
role: PRINCIPAL_INVESTIGATOR
References: