CClinicalTrials.gg
Status unknownNCT03129607Updated Oct 9, 2017

A Study in Postoperative Pancreatic Fistula

An observational study in Pancreatic Cancer, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-09.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • POPF
  • Classification system
03

In context

Pancreatic Fistula

125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.

This study's planned enrollment of 300 is above the median of 173 across 49 observational studies indexed under Pancreatic Fistula.

Browse Pancreatic Fistula studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Participants with diagnosed POPF

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • POPF group

    Patients who had POPF will be included into POPF group.

  • Observation group

    Patients without POPF will be included into observation group.

06

What researchers measure

Primary outcomes

  1. Pancreatic fistula

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

    Time frame: 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 outcomes

  1. Hospital stays

    Post-operation hospital stay is assessed

    Time frame: 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

  2. Number of hospitalizations

    Number of hospitalizations during the observational period

    Time frame: 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

  3. Mortality

    Postoperative death in 30 days are considered concerned with pancreatic fistula

    Time frame: 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

07

Study locations

1 site
  • the second affiliated hospital of Zhejiang University
    Hangzhou, Zhejiang 310009, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03129607
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Apr 26, 2017
Start date
May 1, 2018 (estimated)
Primary completion
May 1, 2020 (estimated)
Completion
May 1, 2020 (estimated)
Last update
Oct 9, 2017

Study contacts

Xue-Li Bai, phD
Contact
shirleybai57@hotmail.com
+86 571 87783510
Ting-Bo Liang, phD
study chair · Second Affiliated Hospital of Zhejiang University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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