Non-Small Cell Lung Cancer
Conditions
Keywords
SurgeoFlex grasp, Systematic lymph node dissection, Uniportal video-assisted thoracoscopic surgery, Minimally invasive thoracic surgery, Lung cancer
Brief summary
This study is testing whether a new, flexible surgical tool-the SurgeoFlex Grasp-makes keyhole chest operations for early-stage lung cancer easier, faster, and safer than the standard rigid tool used today. What is the problem? In keyhole (uniportal) chest surgery, formally known as single-port video-assisted thoracoscopic surgery (VATS), surgeons reach the lung through one small incision between the ribs. Because the operating space is tight, the usual stiff instruments can bump into each other and into surrounding tissues. This difficulty can prolong lymph-node removal and increase the risk of complications. What is being tested? The trial compares two handheld tools: SurgeoFlex Grasp (intervention): a slim, bendable grasper that can be steered around corners. Traditional EndoGrasper (control): a straight, rigid grasper currently used as the standard. Who is taking part? Approximately 100 adults with early-stage non-small-cell lung cancer (NSCLC) (tumours 3 cm or smaller) who are scheduled for keyhole surgery at The First Affiliated Hospital of Guangzhou Medical University. What will happen? Participants are allocated by randomisation into one of two groups: SurgeoFlex group-surgeons use the new flexible tool. Control group-surgeons use the standard rigid tool. All other aspects of the operation, anaesthesia, and post-operative care remain identical for both groups. What is measured? Lymphadenectomy time (duration required to remove the specified lymph nodes). Number of lymph nodes successfully removed. Frequency of surgical-instrument collisions or interference (instrument-clash events). Surgeon workload during the operation (assessed with the National Aeronautics and Space Administration Task Load Index \[NASA-TLX\]). Skin-incision length, pain scores (Visual Analogue Scale \[VAS\]), recovery time, infection rates, and overall cost. Quality-of-life scores one month after surgery (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 \[EORTC QLQ-C30\] and its lung-cancer module \[EORTC QLQ-LC13\]). What is expected? The investigators expect the SurgeoFlex Grasp to shorten operative time, reduce instrument interference, lower surgeon stress, and accelerate recovery without increasing cost. How will this help patients? If the new tool performs as anticipated, future patients undergoing keyhole lung-cancer surgery may experience shorter operations, smaller scars, less pain, and lower infection risk while still obtaining complete cancer-related lymph-node removal. Where is the study taking place? The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. Contact for more information: Clinical Research Management Committee 151 Yanjiang Road, Yuexiu District, Guangzhou 510120, China Email: crmc@gzhmu.edu.cn
Interventions
DEVICEArticulating lymph-node grasper (SurgeoFlex Grasp)
Arm 1 - SurgeoFlex Grasp A single-use, low-profile articulating grasper with a 5-millimetre (mm) shaft and a 360-degree (360°) steerable distal tip. During uniportal video-assisted thoracoscopic surgery (UVATS), the device is introduced through the same 3-4-centimetre (cm) utility incision used for the camera and stapler. The flexible neck allows the jaws to approach hilar and mediastinal lymph nodes from multiple angles without repositioning the instrument shaft, thereby reducing instrument collision and chest-wall torque.
DEVICEArm 2 Intervention Name Traditional rigid endograsper
Arm 2 - Traditional Rigid EndoGrasper A reusable, straight-shafted 5 mm grasper with fixed-angle jaws identical to those used in conventional multi-port video-assisted thoracoscopic surgery (VATS). The instrument is passed through the single 3-4 cm incision in the same fashion as the SurgeoFlex Grasp, but its rigid shaft limits the working angle and often requires external repositioning of the entire instrument to reach deep lymph-node stations.
Sponsors
Jianxing He
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria Inclusion Criteria * Age 18-70 years, any sex * BMI 18.5-30 kg/m² * Newly diagnosed non-small-cell lung cancer with pre-operative clinical stage cT1-2N0-1M0 * Scheduled to undergo single-port video-assisted thoracoscopic lobectomy with systematic lymph-node dissection * Major organ function sufficient for surgery * Written informed consent provided
Exclusion criteria
* Small-cell lung cancer or mixed-type lung cancer * Tumor invasion of main bronchus, chest wall, diaphragm, or major mediastinal vessels * Previous ipsilateral thoracic surgery or prior neoadjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy * Severe cardiopulmonary dysfunction (FEV₁ \<50 % predicted or LVEF \<40 %) * Pregnant or breastfeeding women * Participation in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of Systemic Lymph Node Dissection (SLND) | Intraoperative; measured from the start of the first lymph node packet dissection to the completion of the final packet removal, up to a maximum of 60 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Instrument Collision Counts | Intraoperatively, continuously recorded during systemic lymph node dissection and averaged per case. | — |
| Surgeon Cognitive Load (NASA-TLX score) | Intra-operatively, within 10 minutes after skin closure. | National Aeronautics and Space Administration Task Load Index (NASA-TLX). The NASA-TLX is a multidimensional assessment tool that rates perceived workload across six subscales to assess a task's mental, physical, and temporal demands, as well as the performer's effort, frustration, and performance. The subscale ratings are combined into a weighted composite score. Range: 0-100 points (weighted composite of 6 subscales). Interpretation: Higher scores indicate greater perceived workload. |
| Skin Incision Length | At the end of the operation, before skin closure. | — |
| Post-operative Pain Score (0-10 numeric rating scale) | Daily during the first 3 post-operative days. | — |
| Number of Lymph Nodes Retrieved | Intraoperatively, assessed immediately after the completion of systemic lymph node dissection. | — |
| Operating Room Occupancy Time | Time Frame: Intra-operatively, from skin incision to wound closure, up to 6 hours. | — |
| Health-related Quality of Life (SF-36 score) | Assessed 1 month after surgery. | 36-Item Short-Form Health Survey (SF-36) quality-of-life score. The SF-36 is a standardized, self-administered survey evaluating eight health domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Range: 0-100 points (each of the 8 domains is scored 0-100). Interpretation: A higher score indicates a better health status and quality of life. |
| Incidence of Device Malfunction | From device insertion to device removal, assessed continuously during each operation. | — |
| Incidence of Post-operative Infections | Within 30 days after surgery. | — |
Countries
China
Outcome results
None listed