Incidence of Pancreatic Fistula After Radical Gastrectomy

January 1, 2018 updated by: Shanghai Zhongshan Hospital

Investigation of Incidence of Pancreatic Fistula After Radical Gastrectomy in Gastric Cancer Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

stomach adenocarcinoma patients who recieved radical gastrectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Pancreatic Fistula
Time Frame: in 30 days following gastrectomy
the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients
in 30 days following gastrectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
in 30 days following gastrectomy
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
in 30 days following gastrectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Fenglin Liu, MD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ANTICIPATED)

November 30, 2018

Study Completion (ANTICIPATED)

November 30, 2018

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

January 1, 2018

First Posted (ACTUAL)

January 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 1, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSGC-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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