Clinical trial · Observational
Incidence of Venous Thromboembolism in Patients Undergoing Major Esophageal Resection
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
NCT03115541CI-TRIAL-00050291completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the incidence of post-operative venous thromboembolism (VTE) in patients undergoing major esophageal resection for malignancy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Thoracic Surgery | — | UNRESOLVED | — |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Incidence of PE/DVT after esophageal resection for malignancies
- timeFrame
- post-operative 30 days
- description
- CT pulmonary angiogram and bilateral leg Doppler ultrasound to assess evidence of PE/DVT
- measure
- Incidence of PE/DVT after esophageal resection for malignancies
- timeFrame
- post-operative 60 days
- description
- CT pulmonary angiogram and bilateral leg Doppler ultrasound to assess evidence of PE/DVT
- measure
- Incidence of PE/DVT after esophageal resection for malignancies
- timeFrame
- post-operative 90 days
- description
- CT pulmonary angiogram and bilateral leg Doppler ultrasound to assess evidence of PE/DVT
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDDe Martino RR, Goodney PP, Spangler EL, Wallaert JB, Corriere MA, Rzucidlo EM, Walsh DB, Stone DH. Variation in thromboembolic complications among patients undergoing commonly performed cancer operations. J Vasc Surg. 2012 Apr;55(4):1035-1040.e4. doi: 10.1016/j.jvs.2011.10.129. Epub 2012 Mar 10. PMID 22409858
- BACKGROUNDMukherjee D, Lidor AO, Chu KM, Gearhart SL, Haut ER, Chang DC. Postoperative venous thromboembolism rates vary significantly after different types of major abdominal operations. J Gastrointest Surg. 2008 Nov;12(11):2015-22. doi: 10.1007/s11605-008-0600-1. Epub 2008 Jul 31. PMID 18668299