A Multicenter Clinical Trial on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery

Cai Kailin

Status and phase: Unknown; Phase 3

Conditions: Locally Advanced Gastric Cancer

Treatments: Procedure: open surgery; Procedure: laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02302794

ChiCTR-TRC-14004877

Details and patient eligibility

About

evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).

Full description

Study type：Interventional Study phase：Phase III Objectives of Study：to evaluate the long-term efficacy and safety of oncology between D2 laparoscopic approach distal gastric resection (distal gastrectomy, D2 lymph node dissection) with the current standard surgical treatment model D2 open approach distal gastric resection (distal gastrectomy, D2 lymphadenectomy).

Enrollment: 1,056 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years ~ 75 years;
2. the primary adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma);
3. clinical stage T2-4a, N0-3, M0 (according to AJCC-7th TNM staging);
4. to perform distal gastrectomy, D2 lymph node dissection surgical can obtain R0 resection (multiple primary cancers also apply)
5. ECOG performance status 0/1;
6. ASA score I-III;
7. patient informed consent.

Exclusion criteria

1. pregnant or lactating women;
2. serious mental illness;
3. upper abdominal surgery (except laparoscopic cholecystectomy );
4. gastric surgery (including for gastric ESD / EMR);
5. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
6. other malignant diseases in 5 years;
7. implemented or recommended neoadjuvant therapy in patients with gastric cancer ;
8. have unstable angina or myocardial infarction within six months; (9) have cerebral infarction or cerebral hemorrhage within 6 months; (10) sustained systemic glucocorticoid treatment history within 1 month; (11) have other diseases needed operative treatment at the same time; (12) complications (bleeding, perforation, obstruction) required emergency surgery; (13) 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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1,056 participants in 2 patient groups

open surgery

Active Comparator group

Description:

Conventional procedure

Treatment:

Procedure: open surgery

laparoscopic surgery

Experimental group

Description:

Minimum invasive procedure

Treatment:

Procedure: laparoscopic surgery