A Study in Postoperative Pancreatic Fistula

Study Overview
=================
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.

Official Title
-----------------
An Observational Retrospective Study in Postoperative Pancreatic Fistula

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POPF group<br>Patients who had POPF will be included into POPF group. | |
| Observation group<br>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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POPF, Classification system