Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer (D1D2)

Randomized Controlled Trials Comparing Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer

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）

Study Overview

• Status: Enrolling by invitation
• Conditions: Stomach Neoplasm
• Intervention / Treatment: Procedure: Laparoscopic D1 Lymphadenectomy; Procedure: Laparoscopic D2 Lymphadenectomy

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic D1 Lymphadenectomy; Laparoscopic D1 Lymphadenectomy will be performed for the treatment of patients assigned to this group.	Procedure: Laparoscopic D1 Lymphadenectomy; After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.
Active Comparator: Laparoscopic D2 Lymphadenectomy; Laparoscopic D2 Lymphadenectomy will be performed for the treatment of patients assigned to this group.	Procedure: Laparoscopic D2 Lymphadenectomy; After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease specific survival rate	the rate of 3-year disease specific survival	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The variation of white blood cell count	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.	Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin	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.	Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein	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.	Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of prealbumin	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.	Preoperative 3 days and postoperative 1, 3, and 5 days
3-year overall survival rate	the rate of 3-year overall survival rate	36 months
3-year disease free survival rate	the rate of 3-year disease free survival	36 months
number of retrieved lymph nodes	number of retrieved lymph nodes	1 day
number of positive lymph nodes	number of positive lymph nodes	1 day
intraoperative blood loss	intraoperative blood loss	1 day
the rate of conversion to laparotomy	the rate of conversion to laparotomy	1 day
overall postoperative morbidity rate	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.	30 days
overall postoperative mortality rate	the rate of surgical mortality	30 days
Time to first ambulation	Time to first ambulation in hours is used to assess the postoperative recovery course.	30 days
Time to first flatus	Time to first flatus in days is used to assess the postoperative recovery course.	30 days
Time to first liquid diet	Time to first liquid diet in days is used to assess the postoperative recovery course.	30 days
Time to first soft diet	Time to first soft diet in days is used to assess the postoperative recovery course.	30 days
Duration of postoperative hospital stay	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	30 days
operation time	operation time	1 day

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Elderly Patients; Stomach Neoplasm; Laparoscopic D1 Lymphadenectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2017-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No