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

Peking University Cancer Hospital & Institute

Status: Unknown

Conditions: Gastric Cancer

Treatments: Procedure: open surgery; Procedure: laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02464215

XM201309

Details and patient eligibility

About

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

Full 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.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

open surgery

Active Comparator group

Description:

Conventional procedure,Open surgery

Treatment:

Procedure: open surgery

laparoscopic surgery

Experimental group

Description:

Minimum invasive procedure，Laparoscopic surgery

Treatment:

Procedure: laparoscopic surgery