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

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

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: enhanced recovery after surgery

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: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

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
      • Recruiting
      • Jiangsu Cancer Hospital
      • Contact: Gang LI, M.D.; Email: gang_lee@medmail.com.cn
    • 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: Zhongqi MAO, M.D.; Email: maozq31@hotmail.com
    • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: enhanced recovery after surgery; enhanced recovery after surgery includes: Multimodal analgesia; Early oral intake A: Drink water after anesthetic awareness. B: Recover semi-liquid diet; Management of nasogastric tube and catheter A: Not indwell nasogastric tube conventionally B: Remove catheter early; Early activity; 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

Outcome Measure	Measure Description	Time Frame
occurrence rate of severe complications	including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2017
• Primary Completion (ANTICIPATED): August 31, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (ACTUAL): April 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: gastric cancer; enhanced recovery after surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID 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