NCT02649023

Brief Summary

To investigate the incidence of pre- and early postoperative deep venous thrombosis in patients undergoing hepatobiliopancreatic surgery, as well as potential corresponding risk factors with special attention to circulating tumor cells.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

December 7, 2015

Last Update Submit

March 14, 2019

Conditions

Venous ThrombosisPulmonary EmbolismHepatectomyPancreatectomy

Outcome Measures

Primary Outcomes (1)

  • Deep venous thrombosis on day 3 after surgery

    Patients will be screened for deep venous thrombosis using a compression ultrasonography at the popliteal and common femoral vein. In case of a pathological finding, a complete compression duplex sonography of the lower extremities will be used for specification.

    3 days

Secondary Outcomes (1)

  • Symptomatic deep venous thrombosis or pulmonary embolism during hospital stay

    30 days

Study Arms (2)

A: Patients with deep venous thrombosis

All patients will be screened for deep venous thrombosis on postoperative day 3. Patients with a positive finding will be grouped in arm "A"

B: Patients without deep venous thrombosis

All patients will be screened for deep venous thrombosis on postoperative day 3. Patients with a negative finding will be grouped in arm "B"

Eligibility Criteria

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

Patients scheduled for elective oncological liver or pancreatic resection

You may qualify if:

  • Patients scheduled for elective oncological liver or pancreatic resection
  • Age equal or greater than 18 years
  • Written informed consent

You may not qualify if:

  • Preexistent coagulopathy
  • History of previous VTE
  • benign disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU

Dresden, 01307, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Circulating tumor cells evaluation

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Nuh Rahbari, MD

    Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 7, 2015

First Posted

January 7, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)