Complications
Conditions
Keywords
Laparoscopic gastrectomy, Advanced gastric cancer, Elderly patients, Morbidity, Mortality
Brief 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.
Interventions
PROCEDURELaparoscopic gastrectomy
* 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.
PROCEDUREOpen gastrectomy
* 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complication rate | 30 days | 30 day morbidity and mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pulmonary complications | 30 days | Pulmonary complications after operation within 30 days |
| Postoperative recovery index | 7 days | participants will be followed for the duration of hospital stay after operation, an expected average of 7 days |
Countries
China
Contacts
Primary ContactGuoxin Li, M.D., Ph.D.
Backup ContactHao Liu, M.D., PhD
Outcome results
None listed