Incidence of Pancreatic Fistula After Radical Gastrectomy

• Conditions: Pancreatic Fistula; Complication; Gastric Cancer
• Interventions: Diagnostic Test: Amylase Test

• Registration Number: NCT03391687
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2017-12-15
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-01
• Last Update Submitted: 2018-01-01
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-05
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amylase Test	Amylase Test	gastric cancer patients receiving radical gastrectomy

Primary Outcome Measures

Name	Time	Method
Incidence of Pancreatic Fistula	in 30 days following gastrectomy	the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients

Secondary Outcome Measures

Name	Time	Method
The Classification of Pancreatic Fistula	in 30 days following gastrectomy	the percentage of different grades of pancreatic fistula, including Grade BL, Grade B and Grade C
The mortality of Grade B and C Pancreatic Fistula	in 30 days following gastrectomy	the percentage of patients died of Grade B or C pancreatic fistula

Trial Locations

Locations (20)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

ZhongShan hospital Fudan university; 🇨🇳 Shanghai, Shanghai, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, Beijing, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Weifang People's Hospital; 🇨🇳 Weifang, Shandong, China

South West Hospital; 🇨🇳 Chongqing, Chongqing, China

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

The Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Renji Hospital, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China

Affiliated Hospital of Qinghai University; 🇨🇳 Xining, Qinghai, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China

Ruijing Hospital, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicince; 🇨🇳 Hangzhou, Zhejiang, China

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China