Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer

Phase 2

• Conditions: Stomach Neoplasm
• Interventions: Procedure: Laparoscopic D1 Lymphadenectomy; Procedure: Laparoscopic D2 Lymphadenectomy

• Registration Number: NCT03290209
• Lead Sponsor: Fujian Medical University

Brief Summary

The purpose of this study is to explore the clinical outcomes of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）

Detailed Description

Gastrectomy with D2 lymphadenectomy is considered the gold standard treatment for advanced gastric cancer. However, some studies show that age or comorbidities is the relevant predictor of postoperative complications, conditioning the safety of the surgical procedure itself, thus affect the survial. Even with the advances in surgical techniques and care, age still is a significant risk for postoperative morbidity and mortality. Therefore, elderly patients with gastric cancer could receive minimally invasive surgery with reduced nodal dissection, i.e., D1 lymphadenectomy, in order to prevent postoperative complications. Laparoscopic surgery is a minimally invasive operation and is proved to be an acceptable alternative to open surgery. At present, there is no RCTs to confirm the safety and effectiveness of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma. This study is to compare the clinical outcomes of laparoscopic D1 versus D2 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）to evaluate the safety of laparoscopic D1 lymphadenectomy, and to verify its results in terms of survival in elderly patients with advanced gastric adenocarcinoma.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-21
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Age over or equal to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy, including gastric multiple primary carcinoma
3. cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. expected to perform distal, total or proximal gastrectomy to obtain R0 resection sugicall results.
5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Written informed consent

Exclusion Criteria

1. Severe mental disorder
2. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
3. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
4. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
5. History of other malignant disease within the past 5 years
6. History of previous neoadjuvant chemotherapy or radiotherapy
7. History of unstable angina or myocardial infarction within the past 6 months
8. History of cerebrovascular accident within the past 6 months
9. History of continuous systematic administration of corticosteroids within 1 month
10. Requirement of simultaneous surgery for other disease
11. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
12. FEV1<50% of the predicted values

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic D1 Lymphadenectomy	Laparoscopic D1 Lymphadenectomy	Laparoscopic D1 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
Laparoscopic D2 Lymphadenectomy	Laparoscopic D2 Lymphadenectomy	Laparoscopic D2 Lymphadenectomy will be performed for the treatment of patients assigned to this group.

Primary Outcome Measures

Name	Time	Method
3-year disease specific survival rate	36 months	the rate of 3-year disease specific survival

Secondary Outcome Measures

Name	Time	Method
3-year overall survival rate	36 months	the rate of 3-year overall survival rate
Time to first ambulation	30 days	Time to first ambulation in hours is used to assess the postoperative recovery course.
number of positive lymph nodes	1 day	number of positive lymph nodes
the rate of conversion to laparotomy	1 day	the rate of conversion to laparotomy
The variation of hemoglobin	Preoperative 3 days and postoperative 1, 3, and 5 days	The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
overall postoperative morbidity rate	30 days	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
3-year disease free survival rate	36 months	the rate of 3-year disease free survival
number of retrieved lymph nodes	1 day	number of retrieved lymph nodes
overall postoperative mortality rate	30 days	the rate of surgical mortality
The variation of white blood cell count	Preoperative 3 days and postoperative 1, 3, and 5 days	The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
The variation of C-reactive protein	Preoperative 3 days and postoperative 1, 3, and 5 days	The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time to first flatus	30 days	Time to first flatus in days is used to assess the postoperative recovery course.
Time to first liquid diet	30 days	Time to first liquid diet in days is used to assess the postoperative recovery course.
Time to first soft diet	30 days	Time to first soft diet in days is used to assess the postoperative recovery course.
Duration of postoperative hospital stay	30 days	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
The variation of prealbumin	Preoperative 3 days and postoperative 1, 3, and 5 days	The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
operation time	1 day	operation time
intraoperative blood loss	1 day	intraoperative blood loss

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China