Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients

Phase 3

• Conditions: Complications
• Interventions: Procedure: Laparoscopic gastrectomy; Procedure: Open gastrectomy

• Registration Number: NCT02246153
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-07
• Last Update Posted: 2017-01-10
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic gastrectomy	Laparoscopic gastrectomy	Laparoscopy-assisted distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Open gastrectomy	Open gastrectomy	Open distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Primary Outcome Measures

Name	Time	Method
Postoperative complication rate	30 days	30 day morbidity and mortality

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, China