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A Study in Postoperative Pancreatic Fistula

An Observational Retrospective Study in Postoperative Pancreatic Fistula

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03129607
Enrollment
300
Registered
2017-04-26
Start date
2018-05-01
Completion date
2020-05-01
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

POPF, Classification system

Brief summary

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.

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* No specific

Design outcomes

Primary

MeasureTime frameDescription
Pancreatic fistulaFrom date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 daysThe determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria

Secondary

MeasureTime frameDescription
Hospital staysFrom date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 daysPost-operation hospital stay is assessed
Number of hospitalizationsFrom date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 daysNumber of hospitalizations during the observational period
MortalityFrom date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 daysPostoperative death in 30 days are considered concerned with pancreatic fistula

Countries

China

Contacts

Primary ContactXue-Li Bai, phD
shirleybai57@hotmail.com+86 571 87783510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026