The improved success rate and reduced complications of a novel localization device vs. hookwire for thoracoscopic resection of small pulmonary nodules : a single-center, open-label, randomized clinical trial
2022 Translational Lung Cancer Research. All rights reserved..
Background: In our previous study, we developed a 4-hook claw-suture localization device for pulmonary nodule resection, which acheived satifisfactory results. Following this, we conducted this single-center, open-label, randomized clinical trial to compare the success rate and complication rate of this novel localization device and currently widely-used hookwire.
Methods: Patients with small pulmonary nodules (0.4-1 cm) who received preoperative localization and thoracoscopic resection at Shanghai Chest Hospital were randomly assigned (1:2 ratio, via computer-generated randomized numbers) to undergo localization using either a novel claw-suture system (claw group) or classical (hookwire group) localization device. The primary endpoint of this study was localization success rate, and the secondary endpoints included complications, localization-related time, and pain.
Results: A total of 411 patients were randomly assigned to the claw group (n=136) or the hookwire group (n=275) before thoracoscopic resection of small pulmonary nodules and analyzed. Compared with the hookwire group, the claw group had a significantly higher success rate (133/136, 97.8% vs. 254/275, 92.4%, P=0.027), less asymptomatic hemorrhage (16.9% vs. 37.5%, P=0.003) and pleural reaction (0% vs. 5.1%, P=0.017), as well as better pain alleviation 10 min after localization (measured using the difference between two visual analog scale scores, 0.84±0.98 vs. 0.35±0.79, P<0.001). In contrast, the hookwire group was associated with a shorter localization procedure duration than the claw group (7.2±2.9 vs. 14.4±6.6 min, P<0.001). In the multiple localization subgroup, the claw group compared to the hookwire group also achieved higher success (32/33, 97.0% vs. 70/86, 81.4%) and less pleural reaction (0% vs. 16.3%).
Conclusions: The new claw-suture localization device is superior to traditional hookwire, with a higher success rate, fewer complications, and better patient tolerance for preoperative localization of small pulmonary nodules.
Trial Registration: Chinese Clinical Trial Registry ChiCTR1900027346.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
Translational lung cancer research - 11(2022), 8 vom: 07. Aug., Seite 1702-1712 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Fan, Liwen [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Revised 27.01.2023 published: Print Citation Status PubMed-not-MEDLINE |
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| doi: |
10.21037/tlcr-22-555 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM346076056 |
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| 100 | 1 | |a Fan, Liwen |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The improved success rate and reduced complications of a novel localization device vs. hookwire for thoracoscopic resection of small pulmonary nodules |b a single-center, open-label, randomized clinical trial |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Revised 27.01.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a 2022 Translational Lung Cancer Research. All rights reserved. | ||
| 520 | |a Background: In our previous study, we developed a 4-hook claw-suture localization device for pulmonary nodule resection, which acheived satifisfactory results. Following this, we conducted this single-center, open-label, randomized clinical trial to compare the success rate and complication rate of this novel localization device and currently widely-used hookwire | ||
| 520 | |a Methods: Patients with small pulmonary nodules (0.4-1 cm) who received preoperative localization and thoracoscopic resection at Shanghai Chest Hospital were randomly assigned (1:2 ratio, via computer-generated randomized numbers) to undergo localization using either a novel claw-suture system (claw group) or classical (hookwire group) localization device. The primary endpoint of this study was localization success rate, and the secondary endpoints included complications, localization-related time, and pain | ||
| 520 | |a Results: A total of 411 patients were randomly assigned to the claw group (n=136) or the hookwire group (n=275) before thoracoscopic resection of small pulmonary nodules and analyzed. Compared with the hookwire group, the claw group had a significantly higher success rate (133/136, 97.8% vs. 254/275, 92.4%, P=0.027), less asymptomatic hemorrhage (16.9% vs. 37.5%, P=0.003) and pleural reaction (0% vs. 5.1%, P=0.017), as well as better pain alleviation 10 min after localization (measured using the difference between two visual analog scale scores, 0.84±0.98 vs. 0.35±0.79, P<0.001). In contrast, the hookwire group was associated with a shorter localization procedure duration than the claw group (7.2±2.9 vs. 14.4±6.6 min, P<0.001). In the multiple localization subgroup, the claw group compared to the hookwire group also achieved higher success (32/33, 97.0% vs. 70/86, 81.4%) and less pleural reaction (0% vs. 16.3%) | ||
| 520 | |a Conclusions: The new claw-suture localization device is superior to traditional hookwire, with a higher success rate, fewer complications, and better patient tolerance for preoperative localization of small pulmonary nodules | ||
| 520 | |a Trial Registration: Chinese Clinical Trial Registry ChiCTR1900027346 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a New localization technique | |
| 650 | 4 | |a safety | |
| 650 | 4 | |a small pulmonary nodules | |
| 650 | 4 | |a video-assisted thoracoscopic surgery (VATS) | |
| 700 | 1 | |a Ma, Wenyan |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Jie |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Longtang |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Zhexin |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Ke |e verfasserin |4 aut | |
| 700 | 1 | |a Jia, Yunxuan |e verfasserin |4 aut | |
| 700 | 1 | |a Sun, Beibei |e verfasserin |4 aut | |
| 700 | 1 | |a Sieren, Jessica C |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Haitang |e verfasserin |4 aut | |
| 700 | 1 | |a Yao, Feng |e verfasserin |4 aut | |
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