Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients
Conditions
Complications
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Laparoscopic gastrectomy, Advanced gastric cancer, Elderly patients, Morbidity, Mortality
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Laparoscopic gastrectomy Type: Procedure
Name: Open gastrectomy Type: Procedure
Overall Status
Recruiting
Summary
- Laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer (EGC) has been supported by high-quality evidence, and the high-level evidence for advanced gastric cancer based on large prospective randomized controlled trial as CLASS-01、JCOG 0901, KLASS -02 is still awaited.Hopefully, it would have also gained the solid evidence of laparoscopy-assisted distal gastrectomy for the treatment of advanced gastric cancer (AGC).

- China has entered the aging society since 1999. Among the GC patients in China, the average age is 65 years old, which makes increasing attempts to explore laparoscopic techniques in the treatment of elderly patients.

- Nowadays, a considerable proportion of elderly patients suffer from multiple diseases, such as hypertension, diabetes, coronary heart disease. Thus the risk of intraoperative and postoperative complications can not be ignored. Unfortunately, there are rare studies specializing into the LAG for the GC patients of > 65 years old.

- Accordingly, the comparison of intraoperative and postoperative complications between laparoscopy-assisted and open distal gastrectomy for over 65 years old patients with gastric cancer based on a randomized controlled trial is warranted.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 65 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age over 65 years

- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy

- cT1-4a, 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:

- Severe mental disorder

- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection

- Exclude the early gastric cancer feasible for ESD

- 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
Location
Nanfang Hospital, Southern Medical University
Guangzhou, China
Status: Recruiting
Contact: Guoxin Li, M.D., Ph.D. - +86-138-0277-1450 - gzliguoxin@163.com
Start Date
September 2014
Completion Date
August 2016
Sponsors
Nanfang Hospital of Southern Medical University
Source
Nanfang Hospital of Southern Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page