A Study in Postoperative Pancreatic Fistula

Pancreatic Cancer Clinical Trial

Official title:

An Observational Retrospective Study in Postoperative Pancreatic Fistula

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03129607
• Other study ID #: SAHZhejiangU06
• Status: Not yet recruiting
• Phase: N/A
• First received: April 4, 2017
• Last updated: October 5, 2017
• Start date: May 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: April 2017
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xue-Li Bai, phD
• Phone: +86 571 87783510
• Email: shirleybai57[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Pancreatic Cancer
• Pancreatic Fistula
• Pancreatic Neoplasms

Locations

Country	Name	City	State
China	the second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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