Clinical trial NCT02196675: Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea
Official title: A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 105
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);

Brief summary: Collection of real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices) in a Korean population.

Detailed description: This clinical trial assessed the use of a powered stapler for transection in VATS lung resection, where there is currently limited published clinical data. The primary study endpoint was occurrence and duration of air leak / prolonged air leak (PAL). Procedure details and perioperative outcomes associated with VATS lung resections were also evaluated.

Eligibility criteria: Inclusion Criteria:

* Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
* Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
* Performance status 0-1 (Eastern Cooperative Oncology Group classification);
* ASA score ≤ 3;
* No prior history of VATS or open lung surgery;
* Willing to give consent and comply with study-related evaluation and treatment schedule; and
* At least 19 years of age.

Exclusion Criteria:

* Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
* Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids, (within 30 days prior to study procedure);
* Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure;
* Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
* Pregnancy;
* Physical or psychological condition which would impair study participation;
* The patient is judged unsuitable for study participation by the Investigator for any other reason; or
* Unable or unwilling to attend follow-up visits and examinations.

Primary outcomes:
measure: Occurrence of Prolonged Air Leaks
timeFrame: Post-operative period through hospital discharge and follow-up at Day 30
Secondary outcomes:
measure: Occurrence of Postoperative Air Leaks
timeFrame: Post-operative period through hospital discharge and follow-up at Day 30
measure: Length of Stay (LOS)
timeFrame: Post-operative period through hospital discharge and follow-up at Day 30
measure: Volume of Estimated Intra-operative Blood Loss
timeFrame: Blood loss intra-op and up to 5 days post-op
measure: Time to Chest Tube Removal
timeFrame: Post-operative period through hospital discharge and follow-up at Day 30
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korean University Guro Hospital
Study officials:
affiliation: Johnson & Johson
name: Elliott Fegelman, MD
role: STUDY_DIRECTOR
References: