Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial
© 2015 Wiley Periodicals, Inc..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2015 |
|---|---|
| Erschienen: |
2015 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:112 |
|---|---|
| Enthalten in: |
Journal of surgical oncology - 112(2015), 1 vom: 07. Juli, Seite 18-25 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Gill, Ritu R [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Advanced image guided operating room |
|---|
| Anmerkungen: |
Date Completed 08.10.2015 Date Revised 21.03.2022 published: Print-Electronic ClinicalTrials.gov: NCT01847209 Citation Status MEDLINE |
|---|
| doi: |
10.1002/jso.23941 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM249546531 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM249546531 | ||
| 003 | DE-627 | ||
| 005 | 20231224153818.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231224s2015 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1002/jso.23941 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n0831.xml |
| 035 | |a (DE-627)NLM249546531 | ||
| 035 | |a (NLM)26031893 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Gill, Ritu R |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial |
| 264 | 1 | |c 2015 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 08.10.2015 | ||
| 500 | |a Date Revised 21.03.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01847209 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2015 Wiley Periodicals, Inc. | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial, Phase I | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a C-arm CT | |
| 650 | 4 | |a VATS | |
| 650 | 4 | |a advanced image guided operating room | |
| 650 | 4 | |a fiducials | |
| 650 | 4 | |a hybrid operating room | |
| 650 | 4 | |a lung cancer | |
| 700 | 1 | |a Zheng, Yifan |e verfasserin |4 aut | |
| 700 | 1 | |a Barlow, Julianne S |e verfasserin |4 aut | |
| 700 | 1 | |a Jayender, Jagadeesan |e verfasserin |4 aut | |
| 700 | 1 | |a Girard, Erin E |e verfasserin |4 aut | |
| 700 | 1 | |a Hartigan, Philip M |e verfasserin |4 aut | |
| 700 | 1 | |a Chirieac, Lucian R |e verfasserin |4 aut | |
| 700 | 1 | |a Belle-King, Carol J |e verfasserin |4 aut | |
| 700 | 1 | |a Murray, Kristen |e verfasserin |4 aut | |
| 700 | 1 | |a Sears, Christopher |e verfasserin |4 aut | |
| 700 | 1 | |a Wee, Jon O |e verfasserin |4 aut | |
| 700 | 1 | |a Jaklitsch, Michael T |e verfasserin |4 aut | |
| 700 | 1 | |a Colson, Yolonda L |e verfasserin |4 aut | |
| 700 | 1 | |a Bueno, Raphael |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of surgical oncology |d 1969 |g 112(2015), 1 vom: 07. Juli, Seite 18-25 |w (DE-627)NLM000052930 |x 1096-9098 |7 nnns |
| 773 | 1 | 8 | |g volume:112 |g year:2015 |g number:1 |g day:07 |g month:07 |g pages:18-25 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1002/jso.23941 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 112 |j 2015 |e 1 |b 07 |c 07 |h 18-25 | ||