Multicenter Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer (CLASS-01)

Nanfang Hospital, Southern Medical University

Status and phase

Unknown

Phase 3

Conditions

Stomach Neoplasms

Treatments

Procedure: Open gastrectomy

Procedure: Laparoscopic gastrectomy

Study type

Interventional

Funder types

Other

Identifiers

CLASS - 01

Details and patient eligibility

About

Laparoscopic distal subtotal gastrectomy with lymph node dissection as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asian countries, even though the long-term follow-up outcome based on multicenter randomized clinical trial (RCT) is still awaited.
For the patient with locally advanced gastric cancer, several studies indicated that laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, the application of it is controversial mainly due to lack of solid evidence on the oncologic efficacy. Therefore, conventional open approach is still the current standard for advanced gastric cancer.
Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 per cent of all gastric cancer cases in China. Before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified.
Accordingly,the comparison of intraoperative and postoperative complications between laparoscopic and open distal subtotal gastrectomy for over 65 years old patients with gastric cancer based on a randomized controlled trial is needed.

Enrollment

1,056 estimated patients

Sex

All

Ages

19 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age from over 18 to under 75 years
Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
ASA (American Society of Anesthesiology) score class I, II, or III
Written informed consent

Exclusion criteria

Women during pregnancy or breast-feeding
Severe mental disorder
History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
History of other malignant disease within past five years
History of previous neoadjuvant chemotherapy or radiotherapy
History of unstable angina or myocardial infarction within past six months
History of cerebrovascular accident within past six months
History of continuous systematic administration of corticosteroids within one month
Requirement of simultaneous surgery for other disease
Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
FEV1<50% of predicted values