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2018-05-01
2020-05-01
2020-05-01
300
NCT03129607
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
OBSERVATIONAL
A 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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-04-04 | N/A | 2017-10-05 |
2017-04-23 | N/A | 2017-10-09 |
2017-04-26 | N/A | 2017-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : POPF group Patients who had POPF will be included into POPF group. | |
| : Observation group Patients without POPF will be included into observation group. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pancreatic fistula | 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 | Measure Description | Time Frame |
|---|---|---|
| Hospital stays | 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 | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xue-Li Bai, phD Phone Number: +86 571 87783510 Email: shirleybai57@hotmail.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
