A Study in Postoperative Pancreatic Fistula | NCT03129607

Studies
A Study in Postoperative Pancreatic Fistula

NCT03129607

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Oct 9, 2017Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Pancreatic Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Estimated

Primary Completion Date

May 1, 2020Estimated

Completion Date

May 1, 2020Estimated

First Submitted Date

Apr 4, 2017

First Submission Date that Met QC Criteria

Apr 23, 2017

First Posted Date

Apr 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2017

Last Update Posted Date

Oct 9, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POPF group		Patients who had POPF will be included into POPF group.
Observation group		Patients without POPF will be included into observation group.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants with diagnosed POPF

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xue-Li Bai, phD	Contact	+86 571 87783510		shirleybai57@hotmail.com

Overall Officials

Name	Affiliation	Role
Ting-Bo Liang, phD	Second Affiliated Hospital of Zhejiang University School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the second affiliated hospital of Zhejiang University		Hangzhou	Zhejiang	310009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided