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

Primary Purpose

Stomach Neoplasm

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Laparoscopic D1 Lymphadenectomy
Laparoscopic D2 Lymphadenectomy
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring Stomach Neoplasm, Elderly Patients, Laparoscopic D1 Lymphadenectomy

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian Medical University Union Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic D1 Lymphadenectomy

Laparoscopic D2 Lymphadenectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

3-year disease specific survival rate
the rate of 3-year disease specific survival

Secondary Outcome Measures

3-year overall survival rate
the rate of 3-year overall survival rate
3-year disease free survival rate
the rate of 3-year disease free survival
number of retrieved lymph nodes
number of retrieved lymph nodes
number of positive lymph nodes
number of positive lymph nodes
intraoperative blood loss
intraoperative blood loss
the rate of conversion to laparotomy
the rate of conversion to laparotomy
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.
overall postoperative mortality rate
the rate of surgical mortality
Time to first ambulation
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
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.
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.
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.
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.
operation time
operation time

Full Information

First Posted
September 19, 2017
Last Updated
February 4, 2020
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03290209
Brief Title
Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer
Acronym
D1D2
Official Title
Randomized Controlled Trials Comparing Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
Keywords
Stomach Neoplasm, Elderly Patients, Laparoscopic D1 Lymphadenectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic D1 Lymphadenectomy
Arm Type
Experimental
Arm Description
Laparoscopic D1 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
Arm Title
Laparoscopic D2 Lymphadenectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic D2 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic D1 Lymphadenectomy
Intervention Description
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic D2 Lymphadenectomy
Intervention Description
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.
Primary Outcome Measure Information:
Title
3-year disease specific survival rate
Description
the rate of 3-year disease specific survival
Time Frame
36 months
Secondary Outcome Measure Information:
Title
3-year overall survival rate
Description
the rate of 3-year overall survival rate
Time Frame
36 months
Title
3-year disease free survival rate
Description
the rate of 3-year disease free survival
Time Frame
36 months
Title
number of retrieved lymph nodes
Description
number of retrieved lymph nodes
Time Frame
1 day
Title
number of positive lymph nodes
Description
number of positive lymph nodes
Time Frame
1 day
Title
intraoperative blood loss
Description
intraoperative blood loss
Time Frame
1 day
Title
the rate of conversion to laparotomy
Description
the rate of conversion to laparotomy
Time Frame
1 day
Title
overall postoperative morbidity rate
Description
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
Time Frame
30 days
Title
overall postoperative mortality rate
Description
the rate of surgical mortality
Time Frame
30 days
Title
Time to first ambulation
Description
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Time to first flatus
Description
Time to first flatus in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Time to first liquid diet
Description
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Time to first soft diet
Description
Time to first soft diet in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Duration of postoperative hospital stay
Description
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
The variation of white blood cell count
Description
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.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 days
Title
The variation of hemoglobin
Description
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.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 days
Title
The variation of C-reactive protein
Description
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 Frame
Preoperative 3 days and postoperative 1, 3, and 5 days
Title
The variation of prealbumin
Description
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.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 days
Title
operation time
Description
operation time
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over or equal to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy, including gastric multiple primary carcinoma cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition expected to perform distal, total or proximal gastrectomy to obtain R0 resection sugicall results. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Written informed consent Exclusion Criteria: Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer) Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging History of other malignant disease within the past 5 years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within the past 6 months History of cerebrovascular accident within the past 6 months History of continuous systematic administration of corticosteroids within 1 month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of the predicted values
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changming Huang, Professor
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China

12. IPD Sharing Statement

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

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