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Incidence of Pancreatic Fistula After Radical Gastrectomy

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ClinicalTrials.gov Identifier: NCT03391687
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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

Condition or disease Intervention/treatment
Gastric Cancer Pancreatic Fistula Complication Diagnostic Test: Amylase Test

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.

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Study Type : Observational
Estimated Enrollment : 2100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Incidence of Pancreatic Fistula After Radical Gastrectomy in Gastric Cancer Patients
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Amylase Test
gastric cancer patients receiving radical gastrectomy
Diagnostic Test: Amylase Test
body fluid amylase will be tested after radical gastrectomy in scheduled interval




Primary Outcome Measures :
  1. Incidence of Pancreatic Fistula [ Time Frame: in 30 days following gastrectomy ]
    the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients


Secondary Outcome Measures :
  1. The Classification of Pancreatic Fistula [ Time Frame: in 30 days following gastrectomy ]
    the percentage of different grades of pancreatic fistula, including Grade BL, Grade B and Grade C

  2. The mortality of Grade B and C Pancreatic Fistula [ Time Frame: in 30 days following gastrectomy ]
    the percentage of patients died of Grade B or C pancreatic fistula



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
stomach adenocarcinoma patients who recieved radical gastrectomy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391687


Contacts
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Contact: Zhaoqing Tang, MD +86-13817125778 tang.zhaoqing@zs-hospital.sh.cn

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China
Contact: Ziyu Li, MD         
Principal Investigator: Ziyu Li, MD         
Beijing Chao-Yang Hospital Recruiting
Beijing, Beijing, China
Contact: Minzhe Li, MD         
Principal Investigator: Minzhe Li, MD         
China, Chongqing
South West Hospital Recruiting
Chongqing, Chongqing, China
Contact: Yingxue Hao, MD         
Principal Investigator: Yingxue Hao, MD         
South West Hospital Recruiting
Chongqing, Chongqing, China
Contact: Yongliang Zhao, MD         
Principal Investigator: Yongliang Zhao, MD         
China, Fujian
Fujian Cancer Hospital Recruiting
Fuzhou, Fujian, China
Contact: Weidong Zang, MD         
Principal Investigator: Weidong Zang, MD         
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China
Contact: Chaohui Zheng, MD         
Principal Investigator: Chaohui Zheng, MD         
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Yong Li, MD         
Principal Investigator: Yong Li, MD         
The First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Wu Song, MD         
Principal Investigator: Wu Song, MD         
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China
Contact: Zhi Li, MD         
Principal Investigator: Zhi Li, MD         
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Li Yang, MD         
Principal Investigator: Li Yang, MD         
China, Jiangxi
The First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China
Contact: Zhengrong Li, MD         
Principal Investigator: Zhengrong Li, MD         
China, Jilin
The Second Hospital of Jilin University Recruiting
Changchun, Jilin, China
Contact: Jiaming Zhu, MD         
Principal Investigator: Jiaming Zhu         
China, Qinghai
Affiliated Hospital of Qinghai University Recruiting
Xining, Qinghai, China
Contact: Su Yan, MD         
Principal Investigator: Su Yan, MD         
China, Shandong
Weifang People's Hospital Recruiting
Weifang, Shandong, China
Contact: Jianjun Qu, MD         
Principal Investigator: Jianjun Qu, MD         
China, Shanghai
ZhongShan hospital Fudan university Recruiting
Shanghai, Shanghai, China, 200032
Contact: Fenglin Liu, MD    +86-13918765733    liu.fenglin@zs-hospital.sh.cn   
Principal Investigator: Fenglin Liu, MD         
Renji Hospital, Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China
Contact: Gang Zhao, MD         
Principal Investigator: Gang Zhao, MD         
Ruijing Hospital, Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China
Contact: Junjun Ma, MD         
Contact: Zang Lu, MD         
Sub-Investigator: Junjun Ma, MD         
Principal Investigator: Zang Lu, MD         
China, Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shanxi, China
Contact: Lin Fan, MD         
Principal Investigator: Lin Fan, MD         
China, Xinjiang
The First Affiliated Hospital of Xinjiang Medical University Recruiting
Ürümqi, Xinjiang, China
Contact: Wenbin Zhang, MD         
Principal Investigator: Wenbin Zhang, MD         
China, Zhejiang
Hangzhou First People's Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Jian Zhang, MD         
Principal Investigator: Jian Zhang, MD         
Sir Run Run Shaw Hospital, Zhejiang University School of Medicince Recruiting
Hangzhou, Zhejiang, China
Contact: Linghua Zhu, MD         
Principal Investigator: Linghua Zhu, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Fenglin Liu, MD Fudan University

Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03391687     History of Changes
Other Study ID Numbers: ZSGC-003
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Zhongshan Hospital:
Gastric Cancer
Pancreatic Fistula
Gastrectomy

Additional relevant MeSH terms:
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Stomach Neoplasms
Fistula
Pancreatic Fistula
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathological Conditions, Anatomical
Digestive System Fistula
Pancreatic Diseases