CompletedNot Applicable

Incidence of Venous Thromboembolism in Patients Undergoing Major Esophageal Resection

United States, Canada, China187 participantsStarted 2017-07-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. All patients with known allergic or anaphylactic reaction to contrast dye, heparin, or low molecular weight heparin (LMWH).
. Patients must not be under current anticoagulation for venous thromboembolism or other medical conditions.
. 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.
. Patients with a history of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of PE/DVT after esophageal resection for malignancies

Timeframe: post-operative 30 days

Incidence of PE/DVT after esophageal resection for malignancies

Timeframe: post-operative 60 days

Incidence of PE/DVT after esophageal resection for malignancies

Timeframe: post-operative 90 days

Trial details

NCT IDNCT03115541

SponsorMcMaster University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-02-15

View on ClinicalTrials.gov More Venous Thromboembolism trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. All patients with known allergic or anaphylactic reaction to contrast dye, heparin, or low molecular weight heparin (LMWH).
. Patients must not be under current anticoagulation for venous thromboembolism or other medical conditions.
. 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.
. Patients with a history of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites.