Clinical trial NCT03121729: Enhanced Recovery After Surgery Program for Gastric Cancer: a Multi-center Study
Official title: Enhanced Recovery After Surgery Program for Gastric Cancer: a Multi-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: enhanced recovery after surgery
gastric cancer
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will receive enhanced recovery after surgery programs.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: occurrence rate of severe complications
timeFrame: 1 month
Secondary outcomes:
measure: Occurrence rate of ordinary complications
timeFrame: 1 month
measure: Readmission rate within 30 days after discharge
timeFrame: 1 month
measure: Ideal postoperative length of hospital stay
timeFrame: 1 month
measure: Actual postoperative length of hospital stay
timeFrame: 1 month
measure: Operative time
timeFrame: 1 day
measure: Blood loss
timeFrame: 1 day
measure: Intraoperative infusion
timeFrame: 1 day
measure: TNM classification
timeFrame: 1 week
measure: Number of dissected lymph node
timeFrame: 1 week
measure: Time to first flatus
timeFrame: 2 week
measure: Time to first defecation
timeFrame: 2 week
measure: Time to first semi-liquid diet
timeFrame: 2 week
measure: Time to first off-bed activity
timeFrame: 1 week
measure: Time of off-bed activity per day
timeFrame: 1 week
measure: Distance of off-bed activity per day
timeFrame: 1 week
measure: Postoperative pain
timeFrame: 1 week
measure: Hospital cost
timeFrame: 1 month
measure: Management of catheters
timeFrame: 1 month
measure: Preoperative length of hospital stay
timeFrame: 1 month
measure: CD3+
timeFrame: 1 week
measure: CD4+
timeFrame: 1 week
measure: CD4+/CD8+
timeFrame: 1 week
measure: IL-6
timeFrame: 1 week
measure: CRP
timeFrame: 1 week
measure: Albumin
timeFrame: 1 week
measure: Prealbumin
timeFrame: 1 week
measure: Transferrin
timeFrame: 1 week
measure: Hb
timeFrame: 1 week
measure: WBC
timeFrame: 1 week
measure: PLT
timeFrame: 1 week
measure: HCT
timeFrame: 1 week
measure: Blood glucose
timeFrame: 1 week
measure: Procalcitonin
timeFrame: 1 week
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Changzhou
country: China
facility: Changzhou Second People's Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang City
state: Jiangsu
city: Lianyungang
country: China
facility: The Second People's Hospital of Lianyungang City
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jinling Hospital, Medical School of Nanjing University
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: the Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suqian
country: China
facility: Suqian People's Hospital, Nanjing Drum Tower Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First People's Hospital of Taicang
state: Jiangsu
city: Suzhou
country: China
facility: Zhangjiagang First People's Hospital
state: Jiangsu
city: Taizhou
country: China
facility: the Taizhou People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: The 101 Hospital of the Chinese People's Liberation Army
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University, The Forth People's Hospital of Wuxi City
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated People's Hospital of Jiangsu University
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Zhi-Wei JIANG, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Jian ZHAO, Ph.D.
role: STUDY_DIRECTOR
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Gang WANG, Ph.D.
role: STUDY_DIRECTOR
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Jiang LIU, M.D.
role: STUDY_DIRECTOR
References: