A Study in Postoperative Pancreatic Fistula

October 5, 2017 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

An Observational Retrospective Study in Postoperative Pancreatic Fistula

The International Study Group of Pancreatic Surgery (ISGPS) issued the definition and classification system of postoperative pancreatic fistula (POPF), and received widespread recognition. Currently, it has become an important reference for clinical treatment of POPF.

Study Overview

Status

Unknown

Conditions

Detailed Description

The definition of POPF released by ISGPS in 2016 still seems to have certain deficiency. For example, in both definitions in 2005 and 2016, the re-operation is used as an important judgment index of "Grade C POPF". But a unified standard or consensus is still lacked for the indication of POPF re-operation, which may finally impact the diagnosis of "Grade C POPF". Therefore, we performed this study, so as to better improve the relevant definition and provide guidance for the diagnosis and treatment.

Study Type

Observational

Enrollment (Anticipated)

300

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
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with diagnosed POPF

Description

Inclusion Criteria:

  • Must have a diagnosis of POPF;
  • Aged 18 or older;
  • Of either sex.

Exclusion Criteria:

  • No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial.

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
POPF group
Patients who had POPF will be included into POPF group.
Observation group
Patients without POPF will be included into observation group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic fistula
Time Frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria
From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stays
Time Frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Post-operation hospital stay is assessed
From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Number of hospitalizations
Time Frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Number of hospitalizations during the observational period
From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Mortality
Time Frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Postoperative death in 30 days are considered concerned with pancreatic fistula
From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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 (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 23, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHZhejiangU06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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