A Study in Postoperative Pancreatic Fistula

• Conditions: Pancreatic Cancer

• Registration Number: NCT03129607
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-23
• Study First Posted: 2017-04-26
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-09
• Study Start: 2018-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria

Secondary Outcome Measures

Name	Time	Method
Hospital stays	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
Mortality	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
Number of hospitalizations	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

Trial Locations

Locations (1)

the second affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China