Back to resultsERAS for Patients Received Neoadjuvant Chemotherapy (ERASNAC)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ERAS group
SC group
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients received neoadjuvant chemotherapy with locally advanced gastric cancer.
- Age older than 18 and younger than 75 years.
- American Society of Anesthesiologists (ASA) class: I-III.
- Participants can describe the symptom objectively and cooperate actively.
- Written informed consent.
Exclusion Criteria:
- Patients allergic to oxaliplatin, tegafur gimerac etc.
- Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA)
- Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
- Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min).
- Patients who require simultaneous surgery for other diseases.
- Patients who received upper abdominal surgery previously.
- Pregnant or breast-feeding women.
Sites / Locations
- Jinling Hospital, Medical School of Nanjing University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ERAS group
SC group
Arm Description
Patients will undergo the ERAS programs.
Patients will undergo the SC group.
Outcomes
Primary Outcome Measures
Postoperative length of stay
Postoperative length of stay
Secondary Outcome Measures
Postoperative complications
Postoperative complications
The time to first flatus
Bowel recovery
Time to semi-liquid diet
Bowel recovery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03272984
Brief Title
ERAS for Patients Received Neoadjuvant Chemotherapy
Acronym
ERASNAC
Official Title
Enhanced Recovery After Surgery Programs for Patients Received Neoadjuvant Chemotherapy With Locally Advanced Gastric Cancer: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
June 5, 2017 (Actual)
Study Completion Date
July 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JIANG Zhi-Wei
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
Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.
Detailed Description
Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing postoperative complications. However, in most trials, patients who received neoadjuvant chemotherapy were excluded. The investigators designed this trial for patients received neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled into the ERAS programs for locally advanced gastric cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a parallel, open-label randomized controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERAS group
Arm Type
Experimental
Arm Description
Patients will undergo the ERAS programs.
Arm Title
SC group
Arm Type
Other
Arm Description
Patients will undergo the SC group.
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Intervention Description
ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.
Intervention Type
Procedure
Intervention Name(s)
SC group
Intervention Description
Patients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China.
Primary Outcome Measure Information:
Title
Postoperative length of stay
Description
Postoperative length of stay
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Postoperative complications
Time Frame
2 months
Title
The time to first flatus
Description
Bowel recovery
Time Frame
1 week
Title
Time to semi-liquid diet
Description
Bowel recovery
Time Frame
2 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients received neoadjuvant chemotherapy with locally advanced gastric cancer.
Age older than 18 and younger than 75 years.
American Society of Anesthesiologists (ASA) class: I-III.
Participants can describe the symptom objectively and cooperate actively.
Written informed consent.
Exclusion Criteria:
Patients allergic to oxaliplatin, tegafur gimerac etc.
Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA)
Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min).
Patients who require simultaneous surgery for other diseases.
Patients who received upper abdominal surgery previously.
Pregnant or breast-feeding women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiwei JIANG, MD
Organizational Affiliation
Jinling Hospital, Medical School of Nanjing University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian ZHAO, MD
Organizational Affiliation
Jinling Hospital, Medical School of Nanjing University
Official's Role
Study Director
Facility Information:
Facility Name
Jinling Hospital, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The results and IPD will be considered to share in published articles.
Learn more about this trial
ERAS for Patients Received Neoadjuvant Chemotherapy
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