Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Incidence of Venous Thromboembolism in Patients Undergoing Major Esophageal Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115541
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
McMaster University

Brief Summary:
The purpose of this study is to determine the incidence of post-operative venous thromboembolism (VTE) in patients undergoing major esophageal resection for malignancy.

Condition or disease
Venous Thromboembolism Thoracic Surgery Esophageal Cancer

Detailed Description:

Venous Thromboembolism (VTE) is a common post-operative complication that can result in significant patient morbidity, mortality and health care resource utilization to treat the resultant Pulmonary Embolus (PE) or Deep Vein Thrombosis (DVT) events. It is the third leading cause of cardiovascular mortality. Due to the high burden of disease, VTE events are actively prevented using mechanical and/or pharmaceutical prophylaxis interventions such as compression stockings or a variety of anti-coagulants. Extensive literature identifies incidence rates and provides guidelines regarding the use of prophylaxis measures in orthopaedic and oncological surgery, but the literature in thoracic surgery is sparse at best or conflicting with reported incidence of symptomatic events ranging from 5% to 14% after esophagectomy. The current practice of VTE prophylaxis in thoracic surgery includes administration of unfractionated or low molecular weight heparin (LMWH) starting in the perioperative period and finishing at patient discharge, while prolonged thromboprophylaxis in orthopaedic surgery beyond 10 to 14 days and up to 35 days has become the standard of care. Such an approach has never been tested or validated in esophageal cancer patients despite the substantial burden and high risk of VTE events in this population. There is a clear need for well-designed studies aiming to define the extent of peri-operative VTE for esophagectomy patients and additional contributing factors associated with VTE in those high risk patients in order to inform best practice patterns. The investigators hypothesize that the incidence and clinical burden of perioperative VTE events in esophagectomy patients are substantial, and that VTE significantly contributes to peri-and post-operative morbidity and mortality. Hence, it will be beneficial to explore the true incidence of VTE events and evaluate the effectiveness of extended-duration, post-discharge prophylaxis for these patients. The investigators also hypothesize that sub-groups of esophagectomy patients will be at higher risk for VTE events and therefore might benefit more from extended-duration, post-discharge prophylaxis, and perhaps from a more aggressive in-hospital regimen.

This prospective cohort study will involve patients undergoing major esophageal resection for esophageal cancer at 9 tertiary care centres across Canada, 4 centres in the USA, and 1 site in China. McMaster University at St. Joseph's Healthcare Hamilton will serve as the Coordinating Centre as well as a study site. Recruitment will commence at each site until 177 patients are enrolled via consecutive convenience sampling. After undergoing esophagectomy, all patients will receive both a peri-operative dose followed by post-operative LMWH VTE prophylaxis for the remainder of their hospital stay. As per current VTE prophylaxis guidelines, prophylaxis will be discontinued upon hospital discharge. VTE outcomes will be assessed using Computed Tomography with pulmonary angiography protocol at 30 and 90 days and bilateral venous Doppler ultrasounds at 30, 60 and 90 days after surgery. The role of D-Dimer will be investigated peri-operatively up to post-operative day (POD) 3, at hospital discharge or POD 10 (whichever is applicable), and at each imaging follow-up visit. A future second phase study will be a randomized controlled trial that will evaluate the role of extended duration thromboprophylaxis post-discharge in reducing the incidence of VTE in this patient population. The proposed prospective cohort study to evaluate the incidence of VTE needs to be conducted first, in order to optimize patient selection and determine the sample size for the subsequent randomized controlled trial.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 177 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Contemporary Significance of Deep Venous Thrombosis and Pulmonary Embolus in Patients Undergoing Esophagectomy: A Pilot Study to Evaluate the Incidence of DVT and PE After Major Esophageal Resections
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of PE/DVT after esophageal resection for malignancies [ Time Frame: post-operative 30 days ]
    CT pulmonary angiogram and bilateral leg Doppler ultrasound to assess evidence of PE/DVT

  2. Incidence of PE/DVT after esophageal resection for malignancies [ Time Frame: post-operative 60 days ]
    CT pulmonary angiogram and bilateral leg Doppler ultrasound to assess evidence of PE/DVT

  3. Incidence of PE/DVT after esophageal resection for malignancies [ Time Frame: post-operative 90 days ]
    CT pulmonary angiogram and bilateral leg Doppler ultrasound to assess evidence of PE/DVT


Secondary Outcome Measures :
  1. Incidence of PE and DVT comparing open esophagectomy with minimally invasive surgery [ Time Frame: post-operative 30, 60, 90 days ]
    CT pulmonary angiogram and bilateral leg Doppler ultrasound to assess evidence of PE/DVT

  2. Complications and mortality of DVT and PE post esophageal resection [ Time Frame: post-operative 30, 60, 90 days ]
    Multiple measurements aggregated to arrive at one reported value (e.g., number of participants with adverse events that are related to DVT and PE).

  3. Risk factors for the development of VTE post esophageal resection [ Time Frame: post-operative 30, 60, 90 days ]
    Multiple measurements used including patient characteristics, surgical details, physiological parameters, and patient-reported symptoms questionnaire.

  4. Correlation between D-Dimer levels and VTE events post esophagectomy [ Time Frame: post-operatively up to 3 days after surgery, at hospital discharge/post-operative day 10, and at 30, 60, 90 days after surgery ]
    Blood samples used to assess D-Dimer levels to investigate the role of this laboratory test as a quantifiable clinical measure of VTE risk.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will involve patients undergoing esophageal resection for malignancy.
Criteria

Inclusion Criteria:

  1. Patients must be at least 18 years of age.
  2. Patients may be of either gender.
  3. Patients must be diagnosed with resectable esophageal cancer.
  4. Patients must be undergoing an esophagectomy as either the first-line treatment or after completion of neoadjuvant therapies.
  5. Patients must receive VTE prophylaxis as per local institutional guidelines
  6. Patients must be competent to understand and sign consent documents.

Exclusion Criteria:

  1. All patients with known allergic or anaphylactic reaction to contrast dye, heparin, or low molecular weight heparin (LMWH).
  2. Patients must not be under current anticoagulation for venous thromboembolism or other medical conditions.
  3. Patients must not have known renal impairment, defined as creatinine clearance value of less than 55ml/min/m2 as calculated by the Cockcroft-Gault method.
  4. Patients with a history of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites.
  5. Patients with known hepatic insufficiency, defined as international normalized ratio (INR) >1.5.
  6. Patients must not be pregnant or planning to become pregnant.
  7. Patients must not have been diagnosed or treated for VTE in the past 3 months prior to surgery.
  8. Patients must not have a present or previous increased risk of haemorrhage.
  9. Patients must not have known, objectively confirmed bleeding and clotting disorders such as thrombophilia, von Willebrand's disease, hemophilia or otherwise active bleeding.
  10. Patients must not have a history of previous heparin-induced thrombocytopenia (HIT).
  11. Platelet count must be above 75,000, but transient, recovered thrombocytopenia associated with chemotherapy will not be a basis for exclusion.
  12. Patients must not have previously inserted inferior vena cava (IVC) filter.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115541


Contacts
Layout table for location contacts
Contact: Dr. Yaron Shargall, MD, FRCSC, FCCP 905-522-1155 ext 33229 shargal@mcmaster.ca
Contact: Laura Schneider, MSc 905-522-1155 ext 35877 lschnei@mcmaster.ca

Locations
Layout table for location information
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-5344
Contact: Shari Barnett, RRT    734-936-4561      
Principal Investigator: Jules Lin, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Rhonda Leister    216-444-8774 ext 48774    BLAIRR@ccf.org   
Principal Investigator: Sudish Murthy, MD PhD         
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3T 2N2
Contact: Emma Poole    204 787 5625    epoole@hsc.mb.ca   
Principal Investigator: Biniam Kidane, MD         
Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Deb Lewis    519.685.8500 ext 75685    deb.lewis@lhsc.on.ca   
Principal Investigator: Richard Malthaner, MD MSc         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Edita Delic       edelic@ohri.ca   
Principal Investigator: Andrew Seely, MD PhD         
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Frances Allison    416-340-5446      
Principal Investigator: Gail Darling, MD         
China
Beijing Chao-yang Hospital, Capital Medical University Not yet recruiting
Beijing, China, 8610-85231165
Sponsors and Collaborators
McMaster University
Investigators
Layout table for investigator information
Principal Investigator: Yaron Shargall McMaster University

Publications:
Layout table for additonal information
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03115541    
Other Study ID Numbers: SJHH_VTEesoph001
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
venous thromboembolism prophylaxis
deep vein thrombosis
pulmonary embolus
esophageal resection
incidence
Additional relevant MeSH terms:
Layout table for MeSH terms
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases