A multicenter randomized phase II trial evaluating the efficacy and safety of intrapericardial left superior pulmonary vein ligation or division for prevention of thrombosis in the stump

A multicenter randomized phase II trial evaluating the efficacy and safety of intrapericardial left superior pulmonary vein ligation or division for prevention of thrombosis in the stump - A phase II trial examining the prevention of thrombosis in the left superior pulmonary vein by intrapericardial ligation or division

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036037

Enrollment

Registered

2019-03-01

Start date

2019-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant tumor of the lung

Interventions

A: intrathoracic division B: intrapericardial ligation or division

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Lung cancer patients of left upper lobe 2. Patients who are scheduled for left upper lobectomy via thoracotomy or thoracoscopic approach 3. 20 years <= and 85 years > 4. ECOG performance status of 0 or 1 5. No following surgical history i) left thoracotomy ii) left thoracoscopic resection of lung, esophagus, and mediastinum (except for thoracoscopic resection of bullae) iii) Heart and great vessel surgery (except for thoracic endovascular aortic repair) 6. Satisfy the following conditions i) hilum and mediastinum of the operative site are not included in the radiotherapy field ii) no past history of more than Grade2 radiation pneumonitis at the site of operation 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. The common trunk of the left pulmonary vein 2. Contrast media allergy 3. Renal function disorder or preoperative creatinine level is higher than 1.2 mg/dL 4. Asthma 5. Using biguanide hypoglycemia drug 6. Active infection requiring systemic therapy 7. Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy 8. Severe psychological disorder 9. Atrial fibrillation 10. History of myocardial infarction or attack of angina pectoris within the past 3 weeks 11. Uncontrollable valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy 12. Interstitial pneumonitis 13. a participating surgeon judged that the patient was not appropriate candidate for the study

Design outcomes

Primary

Measure	Time frame
Incidence rates of thrombosis in the left superior pulmonary vein stump (within 30 days after surgery)	—

Secondary

Measure	Time frame
Incidence rates of thrombosis in the left superior pulmonary vein stump (over 31 days after surgery) Operative time Bleeding volume length of thoracic drainage tube placement length of hospital stay Adverse event rates	—

Countries

Japan

Contacts

Public ContactTatsuya Goto

Niigata University Graduate School of Medical and Dental Sciences Division of Thoracic and Cardiovascular Surgery

gotou-akt@umin.ac.jp025-227-2243

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026