Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer

Not Applicable

• Conditions: Stomach Neoplasms
• Interventions: Procedure: Totally Laparoscopic Total Gastrectomy; Procedure: Laparoscopy Assisted Total Gastrectomy

• Registration Number: NCT03006263
• Lead Sponsor: Fujian Medical University

Brief Summary

The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2016-12-26
• Study First Submitted QC: 2016-12-26
• Study First Posted: 2016-12-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Primary Completion: 2021-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Totally Laparoscopic Total Gastrectomy	Totally Laparoscopic Total Gastrectomy	Totally Laparoscopic Total Gastrectomy will be performed for the treatment of patients assigned to this group.
Laparoscopy Assisted Total Gastrectomy	Laparoscopy Assisted Total Gastrectomy	Laparoscopy Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.

Primary Outcome Measures

Name	Time	Method
overall postoperative morbidity rates	30 days	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.

Secondary Outcome Measures

Name	Time	Method
3-year disease free survival rate	36 months
Postoperative pain	30 days	Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course.
The variation of cholesterol	3, 6, 9 and 12 months	The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
The results of endoscopy	3 and 12 months	The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
The variation of body temperature	8 days	The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
3-year recurrence pattern	36 months	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time to first ambulation	30 days	Time to first ambulation in hours is used to assess the postoperative recovery course.
Time to first liquid diet	30 days	Time to first liquid diet in days is used to assess the postoperative recovery course.
The variation of white blood cell count	Preoperative 3 days and postoperative 1, 3, and 5 days	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 and immune response.
The variation of C-reactive protein	Preoperative 3 days and postoperative 1, 3, and 5 days	The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
3-year overall survival rate	36 months
Intraoperative morbidity rates	1 day	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time to first flatus	30 days	Time to first flatus in days is used to assess the postoperative recovery course.
Time to first soft diet	30 days	Time to first soft diet in days is used to assess the postoperative recovery course.
Duration of postoperative hospital stay	30 days	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
The variation of weight	3, 6, 9 and 12 months	The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
The variation of hemoglobin	Preoperative 3 days and postoperative 1, 3, and 5 days	The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.