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

ABSTRACT: 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).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.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??Gy*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.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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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.

Dataset Information

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

Publications

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

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