Clinical trial NCT03391687: Incidence of Pancreatic Fistula After Radical Gastrectomy
Official title: Investigation of Incidence of Pancreatic Fistula After Radical Gastrectomy in Gastric Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Pancreatic Fistula
Complication
Keywords: Gastric Cancer
Pancreatic Fistula
Gastrectomy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 2100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stomach adenocarcinoma patients who recieved radical gastrectomy

Brief summary: This study is designed to investigate the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients.

Detailed description: Pancreatic fistula, which can lead to fatal end, is one of the most serious complications after radical gastrectomy. It is usually treated as a key factor to evaluate the quality of gastrectomy. The incidence of pancreatic fistula is far different between different areas, knowing the prevalence of pancreatic fistula and risk factors can help us to prevent pancreatic fistula and improve the short time outcome of gastric cancer surgery treatment. So, we designed this perspective, multi-center study to investigate the incidence of pancreatic fistula and its outcome in China.

Eligibility criteria: Inclusion Criteria:

* pathological confirmed stomach adenocarcinoma
* preoperative curatively resectable tumor

Exclusion Criteria:

* pancreas resection
* emergent surgery due to gastric cancer acute complications
* cancer of gastric remnant

Primary outcomes:
measure: Incidence of Pancreatic Fistula
timeFrame: in 30 days following gastrectomy
Secondary outcomes:
measure: The Classification of Pancreatic Fistula
timeFrame: in 30 days following gastrectomy
measure: The mortality of Grade B and C Pancreatic Fistula
timeFrame: in 30 days following gastrectomy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
city: Chongqing
country: China
facility: South West Hospital
state: Chongqing
city: Chongqing
country: China
facility: South West Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Xining
country: China
facility: Affiliated Hospital of Qinghai University
state: Qinghai
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Shanghai
country: China
facility: ZhongShan hospital Fudan university
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Ruijing Hospital, Shanghai Jiaotong University
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicince
state: Zhejiang
Study officials:
affiliation: Fudan University
name: Fenglin Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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