Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Procedure: open surgery; Procedure: laparoscopic surgery

• Registration Number: NCT02464215
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced gastric cancer.

Detailed Description

In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth I or BillrothII methods will be used for gastric reconstruction for all cases. For anastomosis, absorbable suture is used. Anastomotic diameter is 5\~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.

Study Timeline

• Study Start: 2014-03-01
• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

1. Age: older than 18 years old，including 18 years old
2. Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma)
3. Cancer core: located at lower part of stomach
4. Preoperative cancer stage : cT2-4a,N0-3,M0 (according to AJCC-7th TNM staging)
5. surgery：subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection
6. ASA score: ≤ 3;ECOG performance status 0/1
7. Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

Exclusion Criteria

1. Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
2. Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
3. Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
4. Patient who was treated because of systemic inflammatory disease
5. Pregnant patient or lactating women
6. Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis
7. serious mental illness
8. gastric surgery (including for gastric ESD / EMR)
9. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
10. other malignant diseases in 5 years
11. have unstable angina or myocardial infarction within six months
12. have cerebral infarction or cerebral hemorrhage within 6 months
13. sustained systemic glucocorticoid treatment history within 1 month
14. have other diseases needed operative treatment at the same time
15. complications (bleeding, perforation, obstruction) required emergency surgery
16. Pulmonary function tests FEV1 <50% of predicted value.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open surgery	open surgery	Conventional procedure,Open surgery
laparoscopic surgery	laparoscopic surgery	Minimum invasive procedure，Laparoscopic surgery

Primary Outcome Measures

Name	Time	Method
Postoperative complication rate	30 days	Surgical complications within 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
3-year disease free survival rate	3 years	3-year disease free survival rate

Trial Locations

Locations (1)

Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute; 🇨🇳 Beijing, Beijing, China