NCT03791450

Brief Summary

The investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,085

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 21, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

December 21, 2018

Last Update Submit

March 1, 2020

Conditions

Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postoperative Pancreatic Fistula(POPF)

    The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.

    Within 30 days after surgery

Secondary Outcomes (5)

  • Morbidity

    Within 90 days after surgery

  • Mortality

    Within 30 days after surgery

  • Duration of operation

    Intraoperative

  • Length of hospital stay after surgery

    From first day after surgery to release from hospital (anticipate 5 days minimally)

  • Hospital costs

    From first day after surgery to release from hospital (anticipate 5 days minimally)

Study Arms (1)

pancreaticoduodenectomy

patients underwent pancreaticoduodenectomy in recent ten years.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.

You may qualify if:

  • Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2018

First Posted

January 2, 2019

Study Start

March 1, 2019

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

CN(1)