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

Gastric Cancer Clinical Trial

— ERASG1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03121729
• Other study ID #: BE2015687
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2017
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: Jinling Hospital, China
• Contact: Zhi-Wei JIANG, Ph.D.
• Phone: 8602580860034
• Email: nzjiangzhiwei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• enhanced recovery after surgery
Undergo an enhanced recovery after surgery program

Locations

Country	Name	City	State
China	Changzhou Second People's Hospital Affiliated to Nanjing Medical University	Changzhou	Jiangsu
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	The First People's Hospital of Lianyungang City	Lianyungang	Jiangsu
China	The Second People's Hospital of Lianyungang City	Lianyungang	Jiangsu
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jinling Hospital, Medical School of Nanjing University	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	the Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu
China	Suqian People's Hospital, Nanjing Drum Tower Hospital	Suqian	Jiangsu
China	Suzhou Municipal Hospital	Suzhou	Jiangsu
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The First People's Hospital of Taicang	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Zhangjiagang First People's Hospital	Suzhou	Jiangsu
China	the Taizhou People's Hospital	Taizhou	Jiangsu
China	Affiliated Hospital of Jiangnan University, The Forth People's Hospital of Wuxi City	Wuxi	Jiangsu
China	The 101 Hospital of the Chinese People's Liberation Army	Wuxi	Jiangsu
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
China	Affiliated People's Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence rate of severe complications	including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation	1 month
Secondary	Occurrence rate of ordinary complications	Except severe complications, Clavien-Dindo classification =? complications need not reoperation	1 month
Secondary	Readmission rate within 30 days after discharge	Readmission rate within 30 days after discharge	1 month
Secondary	Ideal postoperative length of hospital stay	reach discharge criteria	1 month
Secondary	Actual postoperative length of hospital stay	Actual postoperative length of hospital stay	1 month
Secondary	Operative time	Data of operation	1 day
Secondary	Blood loss	Data of operation	1 day
Secondary	Intraoperative infusion	Data of operation	1 day
Secondary	TNM classification	Data of tumor	1 week
Secondary	Number of dissected lymph node	Data of tumor	1 week
Secondary	Time to first flatus	Bowel function recovery	2 week
Secondary	Time to first defecation	Bowel function recovery	2 week
Secondary	Time to first semi-liquid diet	Bowel function recovery	2 week
Secondary	Time to first off-bed activity	Postoperative activity	1 week
Secondary	Time of off-bed activity per day	Postoperative activity	1 week
Secondary	Distance of off-bed activity per day	Postoperative activity	1 week
Secondary	Postoperative pain	VAS classification	1 week
Secondary	Hospital cost	Hospital cost	1 month
Secondary	Management of catheters	including nasogastric tube, catheter, intraperitoneal drain, infusion tube	1 month
Secondary	Preoperative length of hospital stay	Preoperative length of hospital stay	1 month
Secondary	CD3+	Immune indicators	1 week
Secondary	CD4+	Immune indicators	1 week
Secondary	CD4+/CD8+	Immune indicators	1 week
Secondary	IL-6	Inflammatory indicators	1 week
Secondary	CRP	Inflammatory indicators	1 week
Secondary	Albumin	Nutritional indicators	1 week
Secondary	Prealbumin	Nutritional indicators	1 week
Secondary	Transferrin	Nutritional indicators	1 week
Secondary	Hb	Nutritional indicators	1 week
Secondary	WBC	Nutritional indicators	1 week
Secondary	PLT	Nutritional indicators	1 week
Secondary	HCT	Nutritional indicators	1 week
Secondary	Blood glucose	Nutritional indicators	1 week
Secondary	Procalcitonin	Infectious indicator	1 week