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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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