NCT03129607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

October 9, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

April 4, 2017

Last Update Submit

October 5, 2017

Conditions

Pancreatic Cancer

Keywords

POPFClassification system

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

POPF group

Patients who had POPF will be included into POPF group.

Observation group

Patients without POPF will be included into observation group.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with diagnosed POPF

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Ting-Bo Liang, phD

    Second Affiliated Hospital of Zhejiang University School of Medicine

    STUDY CHAIR

Central Study Contacts

Xue-Li Bai, phD

CONTACT

+86 571 87783510shirleybai57@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 26, 2017

Study Start

May 1, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

October 9, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)