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

Fujian Medical University

Status: Invitation-only

Conditions: Stomach Neoplasms

Treatments: Procedure: Totally Laparoscopic Total Gastrectomy; Procedure: Laparoscopy Assisted Total Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03006263

2016YF021-02

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Totally Laparoscopic Total Gastrectomy

Experimental group

Description:

Totally Laparoscopic Total Gastrectomy will be performed for the treatment of patients assigned to this group.

Treatment:

Procedure: Totally Laparoscopic Total Gastrectomy

Laparoscopy Assisted Total Gastrectomy

Experimental group

Description:

Laparoscopy Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.

Treatment:

Procedure: Laparoscopy Assisted Total Gastrectomy