Gastric CancerERASG1NCT03121729
Enhanced Recovery After Surgery Program for Gastric Cancer: a Multi-center Study
A study testing enhanced recovery after surgery in people with Gastric Cancer, run by Jinling Hospital, China at 23 sites in China.
Trial summary
This study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- enhanced recovery after surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 23 sitesChina
- Study dates
- 21 Jun 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- Patients with gastric cancer scheduled for radical gastrectomy and between the age of 18 and 75 years old without considering sex
- ASA physical status I-III
- Participants can follow the drug doses and visit plan
Who cannot join
- Patients certified by a doctor that doesn't fit to participate in this study.
- 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).
- Patients with gastric cancer with distant metastasis.
- Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
- Patients allergic to common drugs, such as opioids, non-steroidal drugs, cephalosporins, etc.
- Patients with operations of gastrointestinal cancer and complicated abdominal operations.
Show all 13Show fewer
- Patients complicated by gastric cancer with complications such as hemorrhage, perforation, obstruction.
- Patients with dyscrasia and severe malnutrition (albumin≤30g/L, weight loss in half a year>10%, SGA classification C, BMI<18, Hb<70g/L).
- Patients with metabolic complications caused by diabetes.
- Patients can't finish enhanced recovery after surgery programs and have contraindications of enhanced recovery after surgery.
- Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
- Patients participated other subjects 3 months before this subject.
- Sponsors or researchers directly involved in the testing or their family members.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites, 23 recruiting
- Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003
Qicheng LU, M.D., changyiluqicheng@sina.com
Qicheng LU, M.D.
- Recruiting
Changzhou Second People's Hospital Affiliated to Nanjing Medical University
Changzhou, Jiangsu, 213164
Liming TANG, M.D., drtanglm@gmail.com
Liming TANG, M.D.
- Recruiting
The First People's Hospital of Lianyungang City
Lianyungang, Jiangsu, 222002
Huiyu CHEN, M.D.
Zengtao BAO, M.D.
- Recruiting
The Second People's Hospital of Lianyungang City
Lianyungang, Jiangsu, 222006
Yongchang MIAO, M.D., lygmiao@sina.com
Gang WANG, M.D.
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
Gang LI, M.D., gang_lee@medmail.com.cn
Gang LI, M.D.
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210000
Hongyong CAO, M.D., caohongy6167@163.com
Hongyong CAO, M.D.
- Recruiting
Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Zhi-Wei JIANG, Ph.D., 8602580860034, nzjiangzhiwei@163.com
Jian ZHAO, Ph.D., 8602580860034, zhaojiangogo@163.com
- Recruiting
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Jingmin WANG, M.D., wjm730222@163.com
Jingmin WANG, M.D.
- Recruiting
the Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Jianping ZHANG, M.D., zhang_jp64@aliyun.com
Qinghong ZHAO, M.D., njzhqh@sina.com
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Lizong SHEN, M.D., shenlz@njmu.edu.cn
Yongbin DING, M.D.
- Recruiting
Suqian People's Hospital, Nanjing Drum Tower Hospital
Suqian, Jiangsu, 223800
Jianqiang WU, M.D., wjq-10@163.com
Jianqiang WU, M.D.
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
Xinhua GU, M.D.
Renbin SHEN, M.D.
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Haorong WU, M.D., wuhaorong666@126.com
Yongyou WU, M.D., 13338706607@126.com
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xinguo ZHU, M.D., zxg45@hotmail.com
Zhongqi MAO, M.D., maozq31@hotmail.com
- Recruiting
The First People's Hospital of Taicang
Suzhou, Jiangsu, 215400
Yi WANG, M.D.
Bing WANG, M.D.
- Recruiting
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, 215600
Shusheng WANG, M.D., Wsszyy2005@163.com
Shusheng WANG, M.D.
- Recruiting
the Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Qinghong LIU, M.D.
Honggang WANG, M.D.
- Recruiting
The 101 Hospital of the Chinese People's Liberation Army
Wuxi, Jiangsu, 214000
Guozhong WU, M.D., jfj101hwugz@sina.cn
Guozhong WU, M.D.
- Recruiting
Affiliated Hospital of Jiangnan University, The Forth People's Hospital of Wuxi City
Wuxi, Jiangsu, 214062
Bojian FEI, M.D., wx4yfbj@163.com
Bojian FEI, M.D.
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Xiaopeng LV, M.D., 18952171977@126.com
Xiaopeng LV, M.D.
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Ping CHEN, M.D., chen86ky@126.com
Xinxin LIU, M.D.
- Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001
Jixiang CHEN, M.D., cyok9@163.com
Jixiang CHEN, M.D.
- Recruiting
Affiliated People's Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212002
Pengcheng JIANG, M.D., jpc18906106623@126.com
Shouliang ZHANG, M.D.
About this study
This study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- enhanced recovery after surgery
- Keywords
- enhanced recovery after surgery, gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced recovery after surgeryProcedure or surgery
Undergo an enhanced recovery after surgery program
| Study group | Role | What they receive |
|---|---|---|
| enhanced recovery after surgery | Experimental | 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 Receives: Procedure: enhanced recovery after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence rate of severe complications
including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation
Measured: 1 month
Secondary outcomes (33)
Occurrence rate of ordinary complications
Except severe complications, Clavien-Dindo classification ≥Ⅱ complications need not reoperation
Measured: 1 month
Readmission rate within 30 days after discharge
Readmission rate within 30 days after discharge
Measured: 1 month
Ideal postoperative length of hospital stay
reach discharge criteria
Measured: 1 month
Actual postoperative length of hospital stay
Actual postoperative length of hospital stay
Measured: 1 month
Operative time
Data of operation
Measured: 1 day
Blood loss
Data of operation
Measured: 1 day
Intraoperative infusion
Data of operation
Measured: 1 day
TNM classification
Data of tumor
Measured: 1 week
Number of dissected lymph node
Data of tumor
Measured: 1 week
Time to first flatus
Bowel function recovery
Measured: 2 week
Time to first defecation
Bowel function recovery
Measured: 2 week
Time to first semi-liquid diet
Bowel function recovery
Measured: 2 week
Time to first off-bed activity
Postoperative activity
Measured: 1 week
Time of off-bed activity per day
Postoperative activity
Measured: 1 week
Distance of off-bed activity per day
Postoperative activity
Measured: 1 week
Postoperative pain
VAS classification
Measured: 1 week
Hospital cost
Hospital cost
Measured: 1 month
Management of catheters
including nasogastric tube, catheter, intraperitoneal drain, infusion tube
Measured: 1 month
Preoperative length of hospital stay
Preoperative length of hospital stay
Measured: 1 month
CD3+
Immune indicators
Measured: 1 week
CD4+
Immune indicators
Measured: 1 week
CD4+/CD8+
Immune indicators
Measured: 1 week
IL-6
Inflammatory indicators
Measured: 1 week
CRP
Inflammatory indicators
Measured: 1 week
Albumin
Nutritional indicators
Measured: 1 week
Prealbumin
Nutritional indicators
Measured: 1 week
Transferrin
Nutritional indicators
Measured: 1 week
Hb
Nutritional indicators
Measured: 1 week
WBC
Nutritional indicators
Measured: 1 week
PLT
Nutritional indicators
Measured: 1 week
HCT
Nutritional indicators
Measured: 1 week
Blood glucose
Nutritional indicators
Measured: 1 week
Procalcitonin
Infectious indicator
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start21 Jun 2017
- Primary completion31 Aug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will receive enhanced recovery after surgery programs.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian ZHAO, Jinling Hospital, China
- Investigators
- Zhi-Wei JIANG, Ph.D., Principal investigator, Jinling Hospital, Medical School of Nanjing UniversityJian ZHAO, Ph.D., Study director, Jinling Hospital, Medical School of Nanjing UniversityGang WANG, Ph.D., Study director, Jinling Hospital, Medical School of Nanjing UniversityJiang LIU, M.D., Study director, Jinling Hospital, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121729
- Sponsor's protocol ID
- BE2015687
- Acronym
- ERASG1
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2017
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Program for Gastric Cancer: a Multi-center Study
- ClinicalTrials.gov ID
- NCT03121729
- Acronym / sponsor ID
- ERASG1 / BE2015687
- Conditions
- Gastric Cancer
- Keywords
- enhanced recovery after surgery, gastric cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will receive enhanced recovery after surgery programs.
| Arm | Type | Receives |
|---|---|---|
| enhanced recovery after surgery | Experimental | Procedure: enhanced recovery after surgeryenhanced 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- Patients with gastric cancer scheduled for radical gastrectomy and between the age of 18 and 75 years old without considering sex
- ASA physical status I-III
- Participants can follow the drug doses and visit plan
Key exclusion criteria (13 listed)
- Patients certified by a doctor that doesn't fit to participate in this study.
- 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).
- Patients with gastric cancer with distant metastasis.
- Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
- Patients allergic to common drugs, such as opioids, non-steroidal drugs, cephalosporins, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced recovery after surgeryUndergo an enhanced recovery after surgery program | Procedure or surgery | enhanced recovery after surgery |
Primary outcome
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
33 secondary outcomes
Occurrence rate of ordinary complications
Time frame: 1 month
Readmission rate within 30 days after discharge
Time frame: 1 month
Ideal postoperative length of hospital stay
Time frame: 1 month
Actual postoperative length of hospital stay
Time frame: 1 month
Operative time
Time frame: 1 day
Blood loss
Time frame: 1 day
Intraoperative infusion
Time frame: 1 day
TNM classification
Time frame: 1 week
Number of dissected lymph node
Time frame: 1 week
Time to first flatus
Time frame: 2 week
Time to first defecation
Time frame: 2 week
Time to first semi-liquid diet
Time frame: 2 week
Time to first off-bed activity
Time frame: 1 week
Time of off-bed activity per day
Time frame: 1 week
Distance of off-bed activity per day
Time frame: 1 week
Postoperative pain
Time frame: 1 week
Hospital cost
Time frame: 1 month
Management of catheters
Time frame: 1 month
Preoperative length of hospital stay
Time frame: 1 month
CD3+
Time frame: 1 week
CD4+
Time frame: 1 week
CD4+/CD8+
Time frame: 1 week
IL-6
Time frame: 1 week
CRP
Time frame: 1 week
Albumin
Time frame: 1 week
Prealbumin
Time frame: 1 week
Transferrin
Time frame: 1 week
Hb
Time frame: 1 week
WBC
Time frame: 1 week
PLT
Time frame: 1 week
HCT
Time frame: 1 week
Blood glucose
Time frame: 1 week
Procalcitonin
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-Wei JIANG, Ph.D. principal investigator
Jinling Hospital, Medical School of Nanjing University
Jian ZHAO, Ph.D. study director
Jinling Hospital, Medical School of Nanjing University
Gang WANG, Ph.D. study director
Jinling Hospital, Medical School of Nanjing University
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced recovery after surgery in people with Gastric Cancer, run by Jinling Hospital, China at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Wei JIANG, Ph.D. (8602580860034, nzjiangzhiwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence rate of severe complications (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.