Venous ThrombosisPOPLITEANCT02649023
Deep Venous Thrombosis After Hepatobiliopancreatic Surgery
An observational study of Venous Thrombosis and Pulmonary Embolism, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis, Pulmonary Embolism, Hepatectomy
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective oncological liver or pancreatic resection
Who may be able to join
- Patients scheduled for elective oncological liver or pancreatic resection
- Age equal or greater than 18 years
- Written informed consent
Who cannot join
- Preexistent coagulopathy
- History of previous VTE
- benign disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU
Dresden, 01307
About this study
Official title: Pre- and Early Postoperative Deep Venous Thrombosis in Patients Undergoing Oncological Hepatic or Panreatic Resection
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.
Read the detailed description
Thromboembolic events are a common cause of morbidity and mortality in oncological patients. Up to 20% of cancer patients suffer from venous thromboembolism (VTE) induced by the underlying malignancy itself. Oncologic gastrointestinal surgery is a well-known risk factor for VTE. About 4-6% of patients undergoing elective hepatobiliopanreatic surgery develop a deep venous thrombosis (DVT) or pulmonary embolism. However, there are no data referring to the incidence of DVT shortly ahead of the surgical event, implementing that a certain percentage of postoperative DVT might have already been acquired before the operation. Furthermore, most studies only evaluate the rate of symptomatic VTE. In this study, all patients undergoing hepatobiliopancreatic surgery will be screened for deep venous thrombosis the day before surgery, on the third postoperative day (primary endpoint) and 90 days after the operation with a 2-point compression sonography of the lower extremities. The development of a symptomatic VTE (DVT or pulmonary embolism) will be recorded as secondary endpoint. Risk factors, perioperative morbidity / mortality and presence of circulating tumor cells will be analyzed with regard to VTE incidence.
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Hepatectomy, Pancreatectomy
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (1)
Symptomatic deep venous thrombosis or pulmonary embolism during hospital stay
Patients who develop clinical signs of a DVT like swelling of the leg, pain or tenderness in the leg, increased warmth, red or discolored skin of the leg, will be diagnosed by complete compression duplex sonography for confirmation of a deep venous thrombosis. Patients who develop clinical signs of pulmonary embolism like unexplained shortness of breath, pain with deep breathing, coughing of blood, chest pain with electrocardiographic signs of right ventricular stress will be diagnosed by CT pulmonary angiography for confirmation of central or peripheral pulmonary embolism.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuh Rahbari, MD, Principal investigator, Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649023
- Sponsor's protocol ID
- VTG-05
- Acronym
- POPLITEA
- Status last verified
- Mar 2019
- First submitted
- 7 Dec 2015
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- and Early Postoperative Deep Venous Thrombosis in Patients Undergoing Oncological Hepatic or Panreatic Resection
- ClinicalTrials.gov ID
- NCT02649023
- Acronym / sponsor ID
- POPLITEA / VTG-05
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Hepatectomy, Pancreatectomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Thromboembolic events are a common cause of morbidity and mortality in oncological patients. Up to 20% of cancer patients suffer from venous thromboembolism (VTE) induced by the underlying malignancy itself. Oncologic gastrointestinal surgery is a well-known risk factor for VTE. About 4-6% of patients undergoing elective hepatobiliopanreatic surgery develop a deep venous thrombosis (DVT) or pulmonary embolism. However, there are no data referring to the incidence of DVT shortly ahead of the surgical event, implementing that a certain percentage of postoperative DVT might have already been acquired before the operation. Furthermore, most studies only evaluate the rate of symptomatic VTE. In this study, all patients undergoing hepatobiliopancreatic surgery will be screened for deep venous thrombosis the day before surgery, on the third postoperative day (primary endpoint) and 90 days after the operation with a 2-point compression sonography of the lower extremities. The development of a symptomatic VTE (DVT or pulmonary embolism) will be recorded as secondary endpoint. Risk factors, perioperative morbidity / mortality and presence of circulating tumor cells will be analyzed with regard to VTE incidence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective oncological liver or pancreatic resection
Key inclusion criteria (3 listed)
- Patients scheduled for elective oncological liver or pancreatic resection
- Age equal or greater than 18 years
- Written informed consent
Key exclusion criteria (3 listed)
- Preexistent coagulopathy
- History of previous VTE
- benign disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Deep venous thrombosis on day 3 after surgery
Time frame: 3 days
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.
1 secondary outcome
Symptomatic deep venous thrombosis or pulmonary embolism during hospital stay
Time frame: 30 days
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuh Rahbari, MD principal investigator
Department of GI, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis and Pulmonary Embolism, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep venous thrombosis on day 3 after surgery (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.