Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes

NCT ID: NCT03743389

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-11-30

Brief Summary

Pigtail catheter(PC) has been used for thoracic drainage in the patients with pneumothorax or traumatic hemothorax/hemopneumothorax, and some study indicated that PC could obtain similar outcomes when comparing with chest tube(CT). Although PC could drain air and fluid out from pleural cavity and also help pulmonary re-expanding, rare reports are available to thoracic post-operative management. Uniportal video-assisted thoracoscopic surgery(VATS) has been widely applied in many medical center in recent years, most of mediastinal nodes could be resected under uniportal-VATS. This study aims to further study the application of 12G PC during post-operative management and comparing the validity and safety between PC(12G) and CT(16F) after uniportal-VATS for mediastinal nodes resection.

Conditions

Mediastinal Nodes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

12G pigtail catheter

Group Type: EXPERIMENTAL

12G pigtail catheter

Intervention Type: DEVICE

12G pigtail catheter would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with the traditional 16F chest tube.

16F chest tube

Group Type: ACTIVE_COMPARATOR

16F chest tube

Intervention Type: DEVICE

16F chest tube would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with 12G pigtail catheter.

Interventions

12G pigtail catheter

12G pigtail catheter would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with the traditional 16F chest tube.

Intervention Type: DEVICE

16F chest tube

16F chest tube would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with 12G pigtail catheter.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Between 18 and 80 years of age.

2. Diagnosed with potentially resectable mediastinal mass.

3. With indication for uniportal-VATS.

4. For whom informed consent will be obtained before the study.

Exclusion Criteria

1. Previous thoracic surgery at the same side.

2. Have to receive open surgery although uniportal-VATS is planned.

3. Pregnancy.

4. Refuse to sigh the consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TJTS-CT001

Identifier Type: -

Identifier Source: org_study_id