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

Fujian Medical University110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Stomach Neoplasms

Interventions

Totally Laparoscopic Total GastrectomyPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Totally Laparoscopic Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.

Laparoscopy Assisted Total GastrectomyPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Laparoscopy Assisted Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

3-year overall survival rate

Time frame: 36 months

3-year disease free survival rate

Time frame: 36 months

3-year recurrence pattern

Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

Time frame: 36 months

Intraoperative morbidity rates

The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

Time frame: 1 day

Time to first ambulation

Time to first ambulation in hours is used to assess the postoperative recovery course.

Time frame: 30 days

Time to first flatus

Time to first flatus in days is used to assess the postoperative recovery course.

Time frame: 30 days

Time to first liquid diet

Time to first liquid diet in days is used to assess the postoperative recovery course.

Time frame: 30 days

Time to first soft diet

Data from ClinicalTrials.gov

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