Enhanced Recovery After Surgery Program for Gastric Cancer: a Multi-center Study (ERASG1)

April 27, 2018 updated by: Jian ZHAO, Jinling Hospital, China
This study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In China, gastric cancer results in the second highest morbidity and mortality rates among all malignancies. It is very important for treatment of gastric cancer to enhance the quality of treatment, increase patients' survival rate and improve the life quality. Now, "Gastric Cancer, Version 3.2016, NCCN Clinical Practice Guidelines in Oncology" and "Japanese gastric cancer treatment guidelines 2014 (ver. 4)" recommended surgical resection for gastric cancer. As a result, increasing the quality of surgery and improving the perioperative measures have a great influence on patients received a gastrectomy. Before, patients discharged on 7-10 days after gastrectomy and recovered 4-8 weeks after surgery. So, it is significant for patients to recover from surgical trauma in order to receive other anti-cancer therapies after gastrectomy. Investigators spent over ten years studying enhanced recovery after surgery programs for gastric cancer and have got some successful experience. Investigators found enhanced recovery after surgery can accelerate patients' recovery without increasing complications.

This study is the first multi-center study of enhanced recovery after surgery for gastric cancer all over the world. During this period, the study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Recruiting
        • The First People's Hospital Of Changzhou
      • Changzhou, Jiangsu, China, 213164
        • Recruiting
        • Changzhou Second People's Hospital affiliated to Nanjing Medical University
      • Lianyungang, Jiangsu, China, 222002
        • Recruiting
        • The First People's Hospital of Lianyungang City
      • Lianyungang, Jiangsu, China, 222006
        • Recruiting
        • The Second People's Hospital of Lianyungang City
        • Contact:
          • Gang WANG, M.D.
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital, Southeast University
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • Jinling Hospital, Medical School of Nanjing University
      • Nanjing, Jiangsu, China, 210000
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing First Hospital
      • Suqian, Jiangsu, China, 223800
        • Recruiting
        • Suqian People's Hospital, Nanjing Drum Tower Hospital
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • Suzhou Municipal Hospital
        • Contact:
          • Renbin SHEN, M.D.
      • Suzhou, Jiangsu, China, 215400
        • Recruiting
        • The First People's Hospital of Taicang
      • Suzhou, Jiangsu, China, 215600
        • Recruiting
        • Zhangjiagang First People's Hospital
      • Taizhou, Jiangsu, China, 225300
        • Recruiting
        • The Taizhou People's Hospital
      • Wuxi, Jiangsu, China, 214000
        • Recruiting
        • The 101 Hospital of the Chinese People's Liberation Army
      • Wuxi, Jiangsu, China, 214062
        • Recruiting
        • Affiliated Hospital of Jiangnan University, The Forth People's Hospital of Wuxi City
      • Xuzhou, Jiangsu, China, 221009
        • Recruiting
        • Xuzhou Central Hospital
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Northern Jiangsu People's Hospital
      • Zhenjiang, Jiangsu, China, 212001
        • Recruiting
        • Affiliated Hospital of Jiangsu University
      • Zhenjiang, Jiangsu, China, 212002
        • Recruiting
        • Affiliated People's Hospital of Jiangsu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable
  2. Patients with gastric cancer scheduled for radical gastrectomy and between the age of 18 and 75 years old without considering sex
  3. ASA physical status I-III
  4. Participants can follow the drug doses and visit plan

Exclusion Criteria:

  1. Patients certified by a doctor that doesn't fit to participate in this study.
  2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received CABG recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
  3. Patients with gastric cancer with distant metastasis.
  4. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
  5. Patients allergic to common drugs, such as opioids, non-steroidal drugs, cephalosporins, etc.
  6. Patients with operations of gastrointestinal cancer and complicated abdominal operations.
  7. Patients complicated by gastric cancer with complications such as hemorrhage, perforation, obstruction.
  8. Patients with dyscrasia and severe malnutrition (albumin≤30g/L, weight loss in half a year>10%, SGA classification C, BMI<18, Hb<70g/L).
  9. Patients with metabolic complications caused by diabetes.
  10. Patients can't finish enhanced recovery after surgery programs and have contraindications of enhanced recovery after surgery.
  11. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
  12. Patients participated other subjects 3 months before this subject.
  13. Sponsors or researchers directly involved in the testing or their family members.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: enhanced recovery after surgery

enhanced recovery after surgery includes:

  1. Multimodal analgesia
  2. Early oral intake A: Drink water after anesthetic awareness. B: Recover semi-liquid diet
  3. Management of nasogastric tube and catheter A: Not indwell nasogastric tube conventionally B: Remove catheter early
  4. Early activity
  5. Perioperative controlled infusion A: Load carbohydrate preoperatively B: No preoperative bowel preparation C: Fast six hours before surgery, no drink two hours before surgery D: Intraoperative liquid management: 3-6ml/kg/h, determined by anesthetists E: Stop intravenous infusion upon 2000-2500ml water and semiliquid diet being taken
Procedure: enhanced recovery after surgery
Undergo an enhanced recovery after surgery program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
occurrence rate of severe complications
Time Frame: 1 month
including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence rate of ordinary complications
Time Frame: 1 month
Except severe complications, Clavien-Dindo classification ≥Ⅱ complications need not reoperation
1 month
Readmission rate within 30 days after discharge
Time Frame: 1 month
Readmission rate within 30 days after discharge
1 month
Ideal postoperative length of hospital stay
Time Frame: 1 month
reach discharge criteria
1 month
Actual postoperative length of hospital stay
Time Frame: 1 month
Actual postoperative length of hospital stay
1 month
Operative time
Time Frame: 1 day
Data of operation
1 day
Blood loss
Time Frame: 1 day
Data of operation
1 day
Intraoperative infusion
Time Frame: 1 day
Data of operation
1 day
TNM classification
Time Frame: 1 week
Data of tumor
1 week
Number of dissected lymph node
Time Frame: 1 week
Data of tumor
1 week
Time to first flatus
Time Frame: 2 week
Bowel function recovery
2 week
Time to first defecation
Time Frame: 2 week
Bowel function recovery
2 week
Time to first semi-liquid diet
Time Frame: 2 week
Bowel function recovery
2 week
Time to first off-bed activity
Time Frame: 1 week
Postoperative activity
1 week
Time of off-bed activity per day
Time Frame: 1 week
Postoperative activity
1 week
Distance of off-bed activity per day
Time Frame: 1 week
Postoperative activity
1 week
Postoperative pain
Time Frame: 1 week
VAS classification
1 week
Hospital cost
Time Frame: 1 month
Hospital cost
1 month
Management of catheters
Time Frame: 1 month
including nasogastric tube, catheter, intraperitoneal drain, infusion tube
1 month
Preoperative length of hospital stay
Time Frame: 1 month
Preoperative length of hospital stay
1 month
CD3+
Time Frame: 1 week
Immune indicators
1 week
CD4+
Time Frame: 1 week
Immune indicators
1 week
CD4+/CD8+
Time Frame: 1 week
Immune indicators
1 week
IL-6
Time Frame: 1 week
Inflammatory indicators
1 week
CRP
Time Frame: 1 week
Inflammatory indicators
1 week
Albumin
Time Frame: 1 week
Nutritional indicators
1 week
Prealbumin
Time Frame: 1 week
Nutritional indicators
1 week
Transferrin
Time Frame: 1 week
Nutritional indicators
1 week
Hb
Time Frame: 1 week
Nutritional indicators
1 week
WBC
Time Frame: 1 week
Nutritional indicators
1 week
PLT
Time Frame: 1 week
Nutritional indicators
1 week
HCT
Time Frame: 1 week
Nutritional indicators
1 week
Blood glucose
Time Frame: 1 week
Nutritional indicators
1 week
Procalcitonin
Time Frame: 1 week
Infectious indicator
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BE2015687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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