Small and/or Deep Lung TumorNCT03395964
Comparison of Preoperative CT Scan Guided and Intraoperative Hybrid DynaCT Scan-Guided Small Lung Tumor Localization
A study testing Hybrid Dyna-CT guided localization and Preoperative CT scan-guided localization in people with Small and/or Deep Lung Tumor, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
It is well known that video-assisted thoracoscopic surgery(VATS) is preferred to open surgery for lung resection because of the use of smaller incisions and optimized postoperative recovery, including a shorter length of hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small and/or Deep Lung Tumor
- What is being tested?
- Hybrid Dyna-CT guided localization and Preoperative CT scan-guided localization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Oct 2018to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lesions <1 cm or those at a distance more than 1.5cm from the lung periphery.
Who cannot join
- confirmed as a malignancy
- Age <18
- serious pulmonary heart disease
- more than one tumors needed localization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Preoperative CT Scan Guided and Intraoperative Hybrid DynaCT Scan-Guided Small Lung Tumor Localization: A Randomized Study
It is well known that video-assisted thoracoscopic surgery(VATS) is preferred to open surgery for lung resection because of the use of smaller incisions and optimized postoperative recovery, including a shorter length of hospitalization. Studies have shown decreased operative and post-operative morbidity with decreased operative times. However, for small nodules (i.e. lesions <1 cm or those at a distance more than 1.5cm from the lung periphery), adequate identification of the target nodule has been be difficult by VATS, and a more significant resection or conversion to thoracotomy is occasionally needed to ensure complete resection.
In order to improve nodule localization, a variety of preoperative localization methods such as CT-guide hook wire or methyl blue dye localization have been proposed and described to mark lung nodules for easier identification of small nodules and help guide resection during VATS. However, there are certain concerns. First, there are the difficult logistics in minimizing the time between the localization procedure and the subsequent surgery. Second, there is concern for patient safety, in particular pneumothorax, during transfer to and from the ward to the radiology department and in the frequent delays and waiting in reception areas prior to transfer to operating heaters. Finally, interdepartmental transfers and delays can also increase the risk of hook-wire dislodgement.
Read more
Theoretically, the aforementioned disadvantage could be solved by performing the localization procedure and the lung surgery in the same hybrid operating room environment.
In the current study, the investigators will perform intraoperative lung tumor localization in CGMH hybrid operation room (Room 51) equipped with the Siemens Artis Zeego system with DynaCT imaging capabilities. The system provides images equivalent to a 16-slice spiral CT scanner in a single 6-s sweep. Through a randomized study design, the advantages, disadvantages, and important considerations of this combined approach will be compared with traditional preoperative CT scan guided localization protocol.
Read the detailed description
Lung Cancer continues to have high morbidity and mortality, and it is estimated that in 2014 in Taiwan there were approximately 11692 new cases and 9167 deaths from lung cancer, which was the first leading cause of cancer deaths. Because 70% of lung cancer patients in Taiwan were diagnosed at late stage, only palliative treatment could be given and prognosis was poor.
Owing so, screening and early detection of early stage lung cancer is of paramount importance. In 2012, the National Lung Screening Trial demonstrated that screening for lung cancer with chest computed tomography (CT) results in a 20% reduction in mortality. Low dose CT(LDCT) has been acknowledged as the most powerful tool for early lung cancer detection. With the increasing use of CT, it is expected that many patients with small lesions (< 2 cm), enlarging lesions, and partially solid lesions that are suspicious for cancer will be discovered and will require surgical resection.
It is well known that video-assisted thoracoscopic surgery(VATS) is preferred to open surgery for lung tumor resection because of the use of smaller incisions and optimized postoperative recovery, including a shorter length of hospitalization. Studies have shown decreased operative and post-operative morbidity with decreased operative times. While this procedure speeds up recovery and potentially reduces complications, the loss of natural vision and tactile sensing makes it difficult for the surgeon to locate the nodules, especially in cases of non-superficial, ground-glass opaque, and small lesions. The yield rate for nodules < 1 cm can be below 40% as studies show. And a more significant resection (more healthy tissue is resected than actually necessary in order to avoid missing the lesion.) or conversion to thoracotomy is occasionally needed to ensure complete resection. In order to improve nodule localization, a variety of methods have been proposed and described to mark lung nodules for easier identification of small nodules and help guide resection during VATS. These ranged from percutaneous image guided injection of a dye (methylene blue) or radio-opaque material such as barium sulphate, to percutaneously placed hookwires and micro-coils in the radiology suite prior to surgery. All these preoperative CT scan guided localization procedures were carried out "outside" operation room and under local anesthesia.
However, there remain certain concerns. First, there are the difficult logistics in minimizing the time between the hookwire procedure and the subsequent surgery. Second, there is concern for patient safety, in particular pneumothorax, during transfer to and from the ward to the radiology department and in the frequent delays and waiting in reception areas prior to transfer to operating theaters. Finally, interdepartmental transfers and delays can also increase the risk of hookwire dislodgement.
Theoretically, the aforementioned disadvantage could be solved by performing the localization procedure and the lung surgery in the same hybrid operating room environment(i.e. Hybrid OR). A hybrid operating room is a surgical theatre that is equipped with advanced medical imaging devices such as fixed C-Arms, CT scanners or MRI scanners. These imaging devices enable minimally-invasive surgery, which is less traumatic for the patient.
Hybrid operating rooms are currently used mainly in cardiac, vascular and neuro-surgery, and could be suitable for a number of other surgical disciplines, such as thoracic surgery.
Using advanced intra-operative imaging in the OR helps to precisely locate and resect the lesion in a potentially tissue-sparing and quick fashion. In order to be able to use image guidance during VATS, rotational angiography has to be performed before the introduction of ports, thus before the lobe in question deflates. This way the lesion is visible through the natural contrast of air. In a second step, hook wires, thread needles, or contrast agent (Lipiodol, Iopamidol) are introduced into or next to the lesion to ensure visibility on the angiogram after lung deflation. Then, the conventional part of VATS starts with the introduction of thoracoscope. The imaging system is used in fluoroscopic mode now, where both the inserted instruments and the previously marked lesion are well visible. A precise resection is now possible. In case contrast agent has been used to mark the lesion, it will also drain into the regional lymph nodes, which then can be resected within the same procedure.
Reviewing the literature, there are several studies reporting the efficacy of Hybrid OR in localization of the lung nodule with good result and acceptable radiation exposure. However, there was no study so far comparing the efficacy of intraoperative localization and preoperative CT guided localization.
In the current study, the investigators will perform intraoperative lung tumor localization in CGMH hybrid OR(Room 51) equipped with the Siemens Artis Zeego system with DynaCT imaging capabilities. The system provides images equivalent to a 16-slice spiral CT scanner in a single 6-s sweep. Through a randomized study design, the advantages, disadvantages, and important considerations of this combined approach will be compared with traditional preoperative CT scan guided localization protocol.
- Conditions
- Small and/or Deep Lung Tumor
- Being tested
- Hybrid Dyna-CT guided localization, Preoperative CT scan-guided localization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Dyna-CT guided localizationProcedure or surgery
We will perform intraoperative lung tumor localization in CGMH hybrid operation room(Room 51) equipped with the Siemens Artis Zeego system with DynaCT imaging capabilities. The system provides images equivalent to a 16-slice spiral CT scanner in a single 6-s sweep.
Preoperative CT scan-guided localizationProcedure or surgery
Preoperative localization of the lung nodule will be carried out in the radiology department on the day of surgery using local anesthesia. CT-guided hook-wire or methyl blue dye will be placed percutaneously through a 22-gauge needle with the distal end deep to the nodule. The patient will then be taken to the operating room, where under general anesthesia with lung isolation, the nodule will be removed by wedge excision with endostaplers (Endo-GIA-II, United States Surgical,Norwalk, Conn; Echelon Endostapler, Ethicon Endo-Surgery, Cincinnati,Ohio) under the guidance of preoperative lung marking. If the lesion could not be excised using the VATS technique, the patient underwent an open thoracotomy.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative CT scan-guided localization | Active comparator | Preoperative localization of the lung nodule will be carried out in the radiology department on the day of surgery using local anesthesia. CT-guided hook-wire or methyl blue dye will be placed percutaneously through a 22-gauge needle with the distal end deep to the nodule. The patient will then be taken to the operating room, where under general anesthesia with lung isolation, the nodule will be removed by wedge excision with endostaplers (Endo-GIA-II, United States Surgical,Norwalk, Conn; Echelon Endostapler, Ethicon Endo-Surgery, Cincinnati,Ohio) under the guidance of preoperative lung marking. If the lesion could not be excised using the VATS technique, the patient underwent an open thoracotomy. Receives: Procedure: Preoperative CT scan-guided localization |
| Hybrid Dyna-CT guided localization | Experimental | Patients will be brought into the Hybrid OR, and placed in the lateral decubitus position. A C-arm CT scan of the pre-determined field of view that included the nodule position will be acquired during an end-inspiratory hold maneuver using a 5 sec scan protocol with 0.36mGy/projection and 248 projections acquired over 200°. The radiologist reviewed the C-arm CT scan to localize the nodule and plan trajectories for percutaneous hook-wire placement using Syngo iGuide needle guidance software. The planned needle pathways will be integrated into the C-arm fluoroscopic imaging system, which provided laser crossbar and guidance markers on fluoroscopy images to direct the needle pathway for hook wire placement. Receives: Procedure: Hybrid Dyna-CT guided localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time
Recording the time of localization procedure, including needle puncture time.
Measured: from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 2 year.
Secondary outcomes (2)
Complications
pneumothorax and hemorrhage
Measured: Beginning from localization until operation, through study completion, an average of 2 year.
Radiation dose
Effective dose estimates were performed using thermoluminescent dosimeters (TLD).
Measured: from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start8 Oct 2018
- Primary completion30 Dec 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Small and/or Deep Lung TumorStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yin-Kai Chao, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395964
- Sponsor's protocol ID
- CGMH-IRB-201600671A3
- Status last verified
- Jan 2020
- First submitted
- 29 Nov 2017
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang BY, Huang JY, Cheng CY, Lin CH, Ko J, Liaw YP. Lung cancer and prognosis in taiwan: a population-based cancer registry. J Thorac Oncol. 2013 Sep;8(9):1128-35. doi: 10.1097/JTO.0b013e31829ceba4.
PubMed 23945383Huang HL, Kung PT, Chiu CF, Wang YH, Tsai WC. Factors associated with lung cancer patients refusing treatment and their survival: a national cohort study under a universal health insurance in Taiwan. PLoS One. 2014 Jul 7;9(7):e101731. doi: 10.1371/journal.pone.0101731. eCollection 2014.
PubMed 24999633Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
PubMed 22610500National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
PubMed 21714641National Lung Screening Trial Research Team; Church TR, Black WC, Aberle DR, Berg CD, Clingan KL, Duan F, Fagerstrom RM, Gareen IF, Gierada DS, Jones GC, Mahon I, Marcus PM, Sicks JD, Jain A, Baum S. Results of initial low-dose computed tomographic screening for lung cancer. N Engl J Med. 2013 May 23;368(21):1980-91. doi: 10.1056/NEJMoa1209120.
PubMed 23697514Oken MM, Hocking WG, Kvale PA, Andriole GL, Buys SS, Church TR, Crawford ED, Fouad MN, Isaacs C, Reding DJ, Weissfeld JL, Yokochi LA, O'Brien B, Ragard LR, Rathmell JM, Riley TL, Wright P, Caparaso N, Hu P, Izmirlian G, Pinsky PF, Prorok PC, Kramer BS, Miller AB, Gohagan JK, Berg CD; PLCO Project Team. Screening by chest radiograph and lung cancer mortality: the Prostate, Lung, Colorectal, and Ovarian (PLCO) randomized trial. JAMA. 2011 Nov 2;306(17):1865-73. doi: 10.1001/jama.2011.1591. Epub 2011 Oct 26.
PubMed 22031728Humphrey LL, Deffebach M, Pappas M, Baumann C, Artis K, Mitchell JP, Zakher B, Fu R, Slatore CG. Screening for lung cancer with low-dose computed tomography: a systematic review to update the US Preventive services task force recommendation. Ann Intern Med. 2013 Sep 17;159(6):411-420. doi: 10.7326/0003-4819-159-6-201309170-00690.
PubMed 23897166Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.
PubMed 24378917Suzuki K, Nagai K, Yoshida J, Ohmatsu H, Takahashi K, Nishimura M, Nishiwaki Y. Video-assisted thoracoscopic surgery for small indeterminate pulmonary nodules: indications for preoperative marking. Chest. 1999 Feb;115(2):563-8. doi: 10.1378/chest.115.2.563.
PubMed 10027460Santambrogio R, Montorsi M, Bianchi P, Mantovani A, Ghelma F, Mezzetti M. Intraoperative ultrasound during thoracoscopic procedures for solitary pulmonary nodules. Ann Thorac Surg. 1999 Jul;68(1):218-22. doi: 10.1016/s0003-4975(99)00459-2.
PubMed 10421144Kim YD, Jeong YJ, I H, Cho JS, Lee JW, Kim HJ, Lee SH, Kim DH. Localization of pulmonary nodules with lipiodol prior to thoracoscopic surgery. Acta Radiol. 2011 Feb 1;52(1):64-9. doi: 10.1258/ar.2010.100307.
PubMed 21498328Mayo JR, Clifton JC, Powell TI, English JC, Evans KG, Yee J, McWilliams AM, Lam SC, Finley RJ. Lung nodules: CT-guided placement of microcoils to direct video-assisted thoracoscopic surgical resection. Radiology. 2009 Feb;250(2):576-85. doi: 10.1148/radiol.2502080442.
PubMed 19188326Finley RJ, Mayo JR, Grant K, Clifton JC, English J, Leo J, Lam S. Preoperative computed tomography-guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):26-31. doi: 10.1016/j.jtcvs.2014.08.055. Epub 2014 Sep 16.
PubMed 25293355Kpodonu J, Raney A. The cardiovascular hybrid room a key component for hybrid interventions and image guided surgery in the emerging specialty of cardiovascular hybrid surgery. Interact Cardiovasc Thorac Surg. 2009 Oct;9(4):688-92. doi: 10.1510/icvts.2009.209429. Epub 2009 Jul 21.
PubMed 19622541Biasi L, Ali T, Ratnam LA, Morgan R, Loftus I, Thompson M. Intra-operative DynaCT improves technical success of endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2009 Feb;49(2):288-95. doi: 10.1016/j.jvs.2008.09.013. Epub 2008 Nov 28.
PubMed 19038527
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative CT Scan Guided and Intraoperative Hybrid DynaCT Scan-Guided Small Lung Tumor Localization: A Randomized Study
- ClinicalTrials.gov ID
- NCT03395964
- Acronym / sponsor ID
- CGMH-IRB-201600671A3
- Conditions
- Small and/or Deep Lung Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well known that video-assisted thoracoscopic surgery(VATS) is preferred to open surgery for lung resection because of the use of smaller incisions and optimized postoperative recovery, including a shorter length of hospitalization. Studies have shown decreased operative and post-operative morbidity with decreased operative times. However, for small nodules (i.e. lesions <1 cm or those at a distance more than 1.5cm from the lung periphery), adequate identification of the target nodule has been be difficult by VATS, and a more significant resection or conversion to thoracotomy is occasionally needed to ensure complete resection.
In order to improve nodule localization, a variety of preoperative localization methods such as CT-guide hook wire or methyl blue dye localization have been proposed and described to mark lung nodules for easier identification of small nodules and help guide resection during VATS. However, there are certain concerns. First, there are the difficult logistics in minimizing the time between the localization procedure and the subsequent surgery. Second, there is concern for patient safety, in particular pneumothorax, during transfer to and from the ward to the radiology department and in the frequent delays and waiting in reception areas prior to transfer to operating heaters. Finally, interdepartmental transfers and delays can also increase the risk of hook-wire dislodgement.
Theoretically, the aforementioned disadvantage could be solved by performing the localization procedure and the lung surgery in the same hybrid operating room environment.
In the current study, the investigators will perform intraoperative lung tumor localization in CGMH hybrid operation room (Room 51) equipped with the Siemens Artis Zeego system with DynaCT imaging capabilities. The system provides images equivalent to a 16-slice spiral CT scanner in a single 6-s sweep. Through a randomized study design, the advantages, disadvantages, and important considerations of this combined approach will be compared with traditional preoperative CT scan guided localization protocol.
Detailed description
Lung Cancer continues to have high morbidity and mortality, and it is estimated that in 2014 in Taiwan there were approximately 11692 new cases and 9167 deaths from lung cancer, which was the first leading cause of cancer deaths. Because 70% of lung cancer patients in Taiwan were diagnosed at late stage, only palliative treatment could be given and prognosis was poor.
Owing so, screening and early detection of early stage lung cancer is of paramount importance. In 2012, the National Lung Screening Trial demonstrated that screening for lung cancer with chest computed tomography (CT) results in a 20% reduction in mortality. Low dose CT(LDCT) has been acknowledged as the most powerful tool for early lung cancer detection. With the increasing use of CT, it is expected that many patients with small lesions (< 2 cm), enlarging lesions, and partially solid lesions that are suspicious for cancer will be discovered and will require surgical resection.
It is well known that video-assisted thoracoscopic surgery(VATS) is preferred to open surgery for lung tumor resection because of the use of smaller incisions and optimized postoperative recovery, including a shorter length of hospitalization. Studies have shown decreased operative and post-operative morbidity with decreased operative times. While this procedure speeds up recovery and potentially reduces complications, the loss of natural vision and tactile sensing makes it difficult for the surgeon to locate the nodules, especially in cases of non-superficial, ground-glass opaque, and small lesions. The yield rate for nodules < 1 cm can be below 40% as studies show. And a more significant resection (more healthy tissue is resected than actually necessary in order to avoid missing the lesion.) or conversion to thoracotomy is occasionally needed to ensure complete resection. In order to improve nodule localization, a variety of methods have been proposed and described to mark lung nodules for easier identification of small nodules and help guide resection during VATS. These ranged from percutaneous image guided injection of a dye (methylene blue) or radio-opaque material such as barium sulphate, to percutaneously placed hookwires and micro-coils in the radiology suite prior to surgery. All these preoperative CT scan guided localization procedures were carried out "outside" operation room and under local anesthesia.
However, there remain certain concerns. First, there are the difficult logistics in minimizing the time between the hookwire procedure and the subsequent surgery. Second, there is concern for patient safety, in particular pneumothorax, during transfer to and from the ward to the radiology department and in the frequent delays and waiting in reception areas prior to transfer to operating theaters. Finally, interdepartmental transfers and delays can also increase the risk of hookwire dislodgement.
Theoretically, the aforementioned disadvantage could be solved by performing the localization procedure and the lung surgery in the same hybrid operating room environment(i.e. Hybrid OR). A hybrid operating room is a surgical theatre that is equipped with advanced medical imaging devices such as fixed C-Arms, CT scanners or MRI scanners. These imaging devices enable minimally-invasive surgery, which is less traumatic for the patient.
Hybrid operating rooms are currently used mainly in cardiac, vascular and neuro-surgery, and could be suitable for a number of other surgical disciplines, such as thoracic surgery.
Using advanced intra-operative imaging in the OR helps to precisely locate and resect the lesion in a potentially tissue-sparing and quick fashion. In order to be able to use image guidance during VATS, rotational angiography has to be performed before the introduction of ports, thus before the lobe in question deflates. This way the lesion is visible through the natural contrast of air. In a second step, hook wires, thread needles, or contrast agent (Lipiodol, Iopamidol) are introduced into or next to the lesion to ensure visibility on the angiogram after lung deflation. Then, the conventional part of VATS starts with the introduction of thoracoscope. The imaging system is used in fluoroscopic mode now, where both the inserted instruments and the previously marked lesion are well visible. A precise resection is now possible. In case contrast agent has been used to mark the lesion, it will also drain into the regional lymph nodes, which then can be resected within the same procedure.
Reviewing the literature, there are several studies reporting the efficacy of Hybrid OR in localization of the lung nodule with good result and acceptable radiation exposure. However, there was no study so far comparing the efficacy of intraoperative localization and preoperative CT guided localization.
In the current study, the investigators will perform intraoperative lung tumor localization in CGMH hybrid OR(Room 51) equipped with the Siemens Artis Zeego system with DynaCT imaging capabilities. The system provides images equivalent to a 16-slice spiral CT scanner in a single 6-s sweep. Through a randomized study design, the advantages, disadvantages, and important considerations of this combined approach will be compared with traditional preoperative CT scan guided localization protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative CT scan-guided localization | Active comparator | Procedure: Preoperative CT scan-guided localizationPreoperative localization of the lung nodule will be carried out in the radiology department on the day of surgery using local anesthesia. CT-guided hook-wire or methyl blue dye will be placed percutaneously through a 22-gauge needle with the distal end deep to the nodule. The patient will then be taken to the operating room, where under general anesthesia with lung isolation, the nodule will be removed by wedge excision with endostaplers (Endo-GIA-II, United States Surgical,Norwalk, Conn; Echelon Endostapler, Ethicon Endo-Surgery, Cincinnati,Ohio) under the guidance of preoperative lung marking. If the lesion could not be excised using the VATS technique, the patient underwent an open thoracotomy. |
| Hybrid Dyna-CT guided localization | Experimental | Procedure: Hybrid Dyna-CT guided localizationPatients will be brought into the Hybrid OR, and placed in the lateral decubitus position. A C-arm CT scan of the pre-determined field of view that included the nodule position will be acquired during an end-inspiratory hold maneuver using a 5 sec scan protocol with 0.36mGy/projection and 248 projections acquired over 200°. The radiologist reviewed the C-arm CT scan to localize the nodule and plan trajectories for percutaneous hook-wire placement using Syngo iGuide needle guidance software. The planned needle pathways will be integrated into the C-arm fluoroscopic imaging system, which provided laser crossbar and guidance markers on fluoroscopy images to direct the needle pathway for hook wire placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- lesions <1 cm or those at a distance more than 1.5cm from the lung periphery.
Key exclusion criteria (4 listed)
- confirmed as a malignancy
- Age <18
- serious pulmonary heart disease
- more than one tumors needed localization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Dyna-CT guided localizationWe will perform intraoperative lung tumor localization in CGMH hybrid operation room(Room 51) equipped with the Siemens Artis Zeego system with DynaCT imaging capabilities. The system provides images equivalent to a 16-slice spiral CT scanner in a single 6-s sweep. | Procedure or surgery | Hybrid Dyna-CT guided localization |
| Preoperative CT scan-guided localizationPreoperative localization of the lung nodule will be carried out in the radiology department on the day of surgery using local anesthesia. CT-guided hook-wire or methyl blue dye will be placed percutaneously through a 22-gauge needle with the distal end deep to the nodule. The patient will then be taken to the operating room, where under general anesthesia with lung isolation, the nodule will be removed by wedge excision with endostaplers (Endo-GIA-II, United States Surgical,Norwalk, Conn; Echelon Endostapler, Ethicon Endo-Surgery, Cincinnati,Ohio) under the guidance of preoperative lung marking. If the lesion could not be excised using the VATS technique, the patient underwent an open thoracotomy. | Procedure or surgery | Preoperative CT scan-guided localization |
Primary outcome
Procedure time
Time frame: from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 2 year.
Recording the time of localization procedure, including needle puncture time.
2 secondary outcomes
Complications
Time frame: Beginning from localization until operation, through study completion, an average of 2 year.
Radiation dose
Time frame: from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 2 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 23945383Wang BY, Huang JY, Cheng CY, Lin CH, Ko J, Liaw YP. Lung cancer and prognosis in taiwan: a population-based cancer registry. J Thorac Oncol. 2013 Sep;8(9):1128-35. doi: 10.1097/JTO.0b013e31829ceba4.
- Background: PubMed 24999633Huang HL, Kung PT, Chiu CF, Wang YH, Tsai WC. Factors associated with lung cancer patients refusing treatment and their survival: a national cohort study under a universal health insurance in Taiwan. PLoS One. 2014 Jul 7;9(7):e101731. doi: 10.1371/journal.pone.0101731. eCollection 2014.
- Background: PubMed 22610500Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
- Background: PubMed 21714641National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
- Background: PubMed 23697514National Lung Screening Trial Research Team; Church TR, Black WC, Aberle DR, Berg CD, Clingan KL, Duan F, Fagerstrom RM, Gareen IF, Gierada DS, Jones GC, Mahon I, Marcus PM, Sicks JD, Jain A, Baum S. Results of initial low-dose computed tomographic screening for lung cancer. N Engl J Med. 2013 May 23;368(21):1980-91. doi: 10.1056/NEJMoa1209120.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin-Kai Chao principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Dyna-CT guided localization and Preoperative CT scan-guided localization in people with Small and/or Deep Lung Tumor, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time (time frame: from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 2 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03395964, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.