Dataset Information

Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial.

ABSTRACT:

Purpose

To facilitate localization and resection of small lung nodules, we developed a prospective clinical trial (ClinicalTrials.gov number NCT01847209) for a novel surgical approach which combines placement of fiducials using intra-operative C-arm computed tomography (CT) guidance with standard thoracoscopic resection technique using image-guided video-assisted thoracoscopic surgery (iVATS).

Methods

Pretrial training was performed in a porcine model using C-arm CT and needle guidance software. Methodology and workflow for iVATS was developed, and a multi-modality team was trained. A prospective phase I-II clinical trial was initiated with the goal of recruiting eligible patients with small peripheral pulmonary nodules. Intra-operative C-arm CT scan was utilized for guidance of percutaneous marking with two T-bars (Kimberly-Clark, Roswell, GA) followed by VATS resection of the tumor.

Results

Twenty-five patients were enrolled; 23 underwent iVATS, one withdrew, and one lesion resolved. Size of lesions were: 0.6-1.8 cm, mean = 1.3 ± 0.38 cm.. All 23 patients underwent complete resection of their lesions. CT imaging of the resected specimens confirmed the removal of the T-bars and the nodule. Average and total procedure radiation dose was in the acceptable low range (median = 1501 μGy*m(2), range 665-16,326). There were no deaths, and all patients were discharged from the hospital (median length of stay = 4 days, range 2-12). Three patients had postoperative complications: one prolonged air-leak, one pneumonia, and one ileus.

Conclusions

A successful and safe step-wise process has been established for iVATS, combining intra-operative C-arm CT scanning and thoracoscopic surgery in a hybrid operating room.

SUBMITTER: Gill RR

PROVIDER: S-EPMC4539147 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Publications

Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial.

Gill Ritu R RR Zheng Yifan Y Barlow Julianne S JS Jayender Jagadeesan J Girard Erin E EE Hartigan Philip M PM Chirieac Lucian R LR Belle-King Carol J CJ Murray Kristen K Sears Christopher C Wee Jon O JO Jaklitsch Michael T MT Colson Yolonda L YL Bueno Raphael R

Journal of surgical oncology 20150528 1

<h4>Purpose</h4>To facilitate localization and resection of small lung nodules, we developed a prospective clinical trial (ClinicalTrials.gov number NCT01847209) for a novel surgical approach which combines placement of fiducials using intra-operative C-arm computed tomography (CT) guidance with standard thoracoscopic resection technique using image-guided video-assisted thoracoscopic surgery (iVATS).<h4>Methods</h4>Pretrial training was performed in a porcine model using C-arm CT and needle gui ...[more]

PMID: 26031893

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Project description:BackgroundVideo-assisted thoracoscopic surgery (VATS) is a commonly performed minimally invasive procedure that has led to lower levels of pain, as well as procedure-related mortality and morbidity. However, VATS requires analgesia that blocks both visceral and somatic nerve fibers for more effective pain control. This randomized controlled trial evaluated the effect of erector spinae plane block (ESPB) in the postoperative analgesia management of patients undergoing VATS.MethodsWe performed a prospective, randomized, single-center study between December 2018 and December 2019. Fifty-four patients were recruited to two equal groups (ESPB and control group). Following exclusion, 46 patients were included in the final analysis. Patients were randomly assigned to receive preoperative ultrasound-guided ESPB with either ropivacaine or saline. The primary outcome was the numeric rating scale (NRS) score, assessed 12 hours postoperatively. Secondary outcomes were the Riker Sedation-Agitation Scale (SAS) score for emergence agitation, postoperative cumulative opioid consumption, length of post-anesthesia care unit (PACU) stay, incidence of postoperative nausea and vomiting (PONV) and dizziness, and ESPB-related adverse events.ResultsThe NRS in the ESPB group during the postoperative period immediately after PACU admission was significantly lower than that in the control group (5.96±1.68 and 7.59±1.18, respectively; P<0.001) and remained lower until 6 hours postoperatively (P=0.001 at 1 hour and P=0.005 at 6 hours). At 12 hours postoperatively, NRS scores were not significantly different between groups (P=0.12). The median [interquartile range (IQR)] of the postoperative rescue pethidine consumption in PACU was significantly lower [25 mg (25 mg)] in the ESPB group than that in the control group [50 mg (56.2 mg); P=0.006]. The median (IQR) of PACU residual time was significantly lower [25 min (10 min)] in the ESPB group than that in the control group [30 min (15 min); P=0.034]. The median (IQR) Riker SAS was also lower in the ESPB group [4 (1.0)] than that in the control group [5 (1.25); P<0.001] in PACU.ConclusionsA single preoperative injection of ESPB with ropivacaine may improve acute postoperative analgesia and emergence agitation in patients undergoing VATS.

Project description:ObjectivesLu's approach for video-assisted thoracoscopic surgery (LVATS), which derives from UVATS, is a novel surgical approach for VATS and carries out micro-innovation for lung cancer resection. The objective of this study is to elucidate the safety, feasibility, and efficacy of this novel surgical approach.MethodsThe clinical data of patients with non-small cell lung cancer (NSCLC) who underwent a curative thoracoscopic lobectomy between Mar. 2021 and Mar. 2022, were retrospectively collected, and analyzed. According to whether applied Lu's approach during the VATS operation, patients were divided into the LVATS group and the UVATS group. The propensity score (PS) matching method was used to reduce selection bias by creating two groups. After generating the PSs, 1:1 ratio and nearest-neighbor score matching was completed. Perioperative variables, including the operation time, intraoperative blood loss, lymph node stations dissected, total drainage volume, drainage duration, postoperative hospital stay, pain score (VAS, Visual Analogue Scale) on the postoperative first day (POD1) and third day (POD3), and incidence of postoperative complications, were compared between the two groups. The data were analyzed statistically with P<0.05 defined as statistically significant.ResultsA total of 182 patients were identified, among whom 86 patients underwent LVATS and 96 UVATS. Propensity matching produced 62 pairs in this retrospective study. There were no deaths during perioperative period. Patients in the LVATS group experienced a shorter operation time (88 (75, 106) VS 122 (97, 144)min, P <0.001), less intraoperative blood loss(20 (20, 30) VS 25 (20, 50)ml, P = 0.021), shorten incision length (2.50 (2.50, 2.50) VS 3.00 (3.00, 3.50)cm, P <0.001), and more drainage volume (460 (310, 660) VS 345 (225, 600)ml, P = 0.041) than patients in the UVATS group. There was not significant difference in the lymph node stations dissected(5 (4, 5) VS 5 (4, 5), P = 0.436), drainage duration (3 (3, 4) VS 3 (3, 4)days, P = 0.743), length of postoperative hospital stay (4 (4, 5) VS 4 (4, 6)days, P = 0.608), VAS on the POD1(4 (4, 4) VS 4 (4, 4), P = 0.058)and POD3 (3 (3, 4) VS 4 (3, 4), P = 0.219), and incidence of postoperative complications (P = 0.521) between the two groups.ConclusionsLu's approach is a safe and feasible approach for video-assisted thoracoscopic surgery for the lobectomy of NSCLC. This approach can shorten surgical time, reduce incision length and intraoperative blood loss.

Project description:BackgroundSurgery for oesophageal squamous cell carcinoma involves dissecting lymph nodes along the recurrent laryngeal nerve. This is technically challenging and injury to the recurrent laryngeal nerve may lead to vocal cord palsy, which increases the risk of pulmonary complications. The aim of this study was to compare the efficacy and safety of robot-assisted oesophagectomy (RAO) versus video-assisted thoracoscopic oesophagectomy (VAO) for dissection of lymph nodes along the left RLN.MethodsPatients with oesophageal squamous cell carcinoma who were scheduled for minimally invasive McKeown oesophagectomy were allocated randomly to RAO or VAO, stratified by centre. The primary endpoint was the success rate of left recurrent laryngeal nerve lymph node dissection. Success was defined as the removal of at least one lymph node without causing nerve damage lasting longer than 6 months. Secondary endpoints were perioperative and oncological outcomes.ResultsFrom June 2018 to March 2022, 212 patients from 3 centres in Asia were randomized, and 203 were included in the analysis (RAO group 103; VAO group 100). Successful left recurrent laryngeal nerve lymph node dissection was achieved in 88.3% of the RAO group and 69% of the VAO group (P < 0.001). The rate of removal of at least one lymph node according to pathology was 94.2% for the RAO and 86% for the VAO group (P = 0.051). At 1 week after surgery, the RAO group had a lower incidence of left recurrent laryngeal nerve palsy than the VAO group (20.4 versus 34%; P = 0.029); permanent recurrent laryngeal nerve palsy rates at 6 months were 5.8 and 20% respectively (P = 0.003). More mediastinal lymph nodes were dissected in the RAO group (median 16 (i.q.r. 12-22) versus 14 (10-20); P = 0.035). Postoperative complication rates were comparable between the two groups and there were no in-hospital deaths.ConclusionIn patients with oesophageal squamous cell carcinoma, RAO leads to more successful left recurrent laryngeal nerve lymph node dissection than VAO, including a lower rate of short- and long-term recurrent laryngeal nerve injury. Registration number: NCT03713749 (http://www.clinicaltrials.gov).

Dataset Information

Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial.

Purpose

Methods

Results

Conclusions

Publications

Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial.

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