Segmentectomy After Induction Therapy (SAINT)
NCT Number: NCT06496659
Acronym: SAINT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Segmentectomy
Interventions: PROCEDURE: Segmentectomy
Sponsor: Northwestern University
Collaborators: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2029-07-30
Locations: Northwestern University, Chicago, Illinois, 60611, United States

Summary:
The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less). T1c is tumor staging 1 and c stands for tumor is considered larger than 2cm but no larger than 3cm across; N0 is No regional lymph node metastasis; M0 is No distant metastasis.

Primary Outcome Measures: Number of participants with Segmentectomy and R0 on final pathology, The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less).

To address the primary objective, the proportion of patients who receive high-quality segmentectomy will be determined immediately at the end of the operation and R0 rates on final pathology will be collected after the surgical operation when pathological reports are completed., Up to 48 hours after date of surgical resection
Secondary Outcome Measures: R0 resection rates - on final pathology (post-surgery) if converted to lobectomy, The proportion of patients who received lobectomy with R0 resection on final pathology (post-surgery)., Up to 48 hours after date of surgical resection|Ability to complete the intended procedure (sublobar anatomic resection), The proportion of patients with completion of the intended procedure (sublobar anatomic resection) based on the extent of surgical resection immediately at the end of the operation, Up to 24 hours after date of surgical resection|Conversion to lobectomy in a separate operation from sublobar anatomic resection, The proportion of patients who were converted to lobectomy during the operation or within six weeks after the operation for patients who undergo revision., Up to 6 weeks after date of surgical resection|Safety, measured as perioperative outcomes (Post-operative length of stay), Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (post-operative length-of-stay):

• Post-operative length of stay defined from the date of surgery until hospital discharge.

-Outcome measured in number of days, Up to 30 days after date of surgical resection|Safety, measured as perioperative outcomes (post-operative discharge destination), Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (post-operative discharge destination)

• Post-operative discharge destination defined as including: i. Home ii. Extended Care/ Transitional Care Unit/ Rehab iii. Other Hospital iv. Nursing Home v. Hospice vi. Other vii. Expired, Up to 30 days after date of surgical resection|Safety, measured as perioperative outcomes (time to chest tube removal), Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (time to chest tube removal)

-Outcome measured as number of days from date of surgical resection to time of chest tube removal, Up to 30 days after date of surgical resection|Safety, measured as perioperative outcomes (blood transfusion requirements), Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (blood transfusion requirements)

-Outcome measured as number of units blood transfused, if required, Up to 30 days after date of surgical resection|Safety, measured as perioperative outcomes (30-day unplanned readmission), Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (30-day unplanned readmission)

-Outcome measured as number of days if unplanned readmission required after date of discharge following surgical resection and reasoning for readmission, Up to 30 days after date of surgical resection|Safety, measured as perioperative outcomes (30-day morbidity), Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (30-day morbidity)

-Outcome measured as status of participant at 30 days post-discharge from surgical resection procedure (alive or deceased), Up to 30 days after date of surgical resection|Safety, measured as perioperative outcomes (30-day mortality), Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (30-day mortality)

-Outcome measured as date of death within 30 days following discharge from surgical resection procedure, Up to 30 days after date of surgical resection|Change in pre-operative FEV1 (forced expiratory volume at one second) at 3 and 6 months for lobectomy and sublobar anatomic resection, Changes in FEV1 pulmonary function from baseline to 3 and 6 months following lung resection for patients who receive sublobar anatomic resection or are converted to lobectomy.

FEV1 will be measured using pulmonary function tests and expressed as % of expected value. Changes in FEV1 measured at baseline and at 3 and 6 months post-surgery, Prior to surgical resection (baseline) and after surgical resection (3 months and 6 months)