Overview

This trial is active, not recruiting.

Condition stomach neoplasms
Treatments laparoscopic gastrectomy, open gastrectomy
Phase phase 3
Sponsor Nanfang Hospital of Southern Medical University
Start date September 2012
End date December 2017
Trial size 1056 participants
Trial identifier NCT01609309, CLASS - 01

Summary

- 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
laparoscopic gastrectomy LDG
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy.
(Active Comparator)
Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
open gastrectomy ODG
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, open distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.

Primary Outcomes

Measure
3-year disease free survival rate
time frame: 36 months

Secondary Outcomes

Measure
Morbidity and mortality
time frame: 30 days; 36 months
3-year overall survival rate
time frame: 36 months
3-year recurrence pattern
time frame: 36 months
Postoperative recovery course
time frame: 10 days
Inflammatory and immune response
time frame: 7 days

Eligibility Criteria

Male or female participants from 19 years up to 74 years old.

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

Additional Information

Official title Multicenter Study on Comparison of Long-term Outcome Between Laparoscopic and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
Principal investigator Guoxin Li, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Nanfang Hospital of Southern Medical University.