Video-Assisted Thoracic SurgeryNCT02647775
Hemodynamic and Inflammatory Responses in Thoracic Surgery
A study testing multi-port VATS and single-port VATS in people with Video-Assisted Thoracic Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Video-assisted thoracoscopic surgery (VATS) for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Video-Assisted Thoracic Surgery
- What is being tested?
- multi-port VATS and single-port VATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Dec 2018
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with thoracic surgical diseases(lung cancer. mediastinal tumor. solitary pulmonary lesion. pneumothorax) who will be underwent video-assisted thoracic surgery
Who cannot join
- Unresectable mediastinal tumor
- Previous history of ipsilateral pulmonary resection
- Patients with complex cardiopulmonary dysfunction
- Unresectable pulmonary hilar tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic and Inflammatory Responses in Thoracic Surgery: Hemodynamic and Inflammatory Responses Following Video-assisted Thoracoscopic Surgery
Video-assisted thoracoscopic surgery (VATS) for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy. The specific aims of this project are: to clarify the physiologic and immunologic effects of different approaches for minimally invasive thoracic surgery: (1) multiple-port VATS; (2) single-port VATS
Read the detailed description
Video-assisted thoracoscopic surgery (VATS) was first reported in the early 1990s. Since then, the safety and efficacy of thoracoscopy for diagnosing and treating pleural, pulmonary, and mediastinal disease has been demonstrated with similar oncological results, which were confirmed by multiple clinical studies. Although VATS for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy, unfortunately chronic thoracic wound discomfort and postoperative neuralgia were found in a significant portion of patients .
Recently, a minimally invasive approach that is different from the conventional multiport thoracoscopic technique is gradually becoming of great interest in the diagnosis and treatment of thoracic surgical disease. Single-port VATS is one of the most promising emerging surgical techniques which allows the surgeon to perform a majority of thoracic surgeries and with similar perioperative outcomes that are comparable with the conventional multiport technique. However, a very limited number of clinical studies have demonstrated the advantages of single port VATS in postoperative pain reduction, when comparing to the traditional multiport thoracoscopic approach.
To clarify the physiologic and immunologic effects of different approaches for minimally invasive thoracic surgery, investigators aim to compare the perioperative physiological changes, immunological responses, and postoperative pain between standard (multi-port) transthoracic thoracoscopic and single-port transthoracic thoracoscopic surgery for thoracic disease.
- Conditions
- Video-Assisted Thoracic Surgery
- Being tested
- multi-port VATS, single-port VATS
- Keywords
- Thoracoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-port VATSProcedure or surgery
Patients with thoracic surgical diseases who underwent VATS will be recruited into this study to investigate the postoperative pain , physiologic and immunologic impacts of two different approaches for minimally invasive thoracic surgery.
single-port VATSProcedure or surgery
Patients with thoracic surgical diseases who underwent VATS will be recruited into this study to investigate the postoperative pain , physiologic and immunologic impacts of two different approaches for minimally invasive thoracic surgery.
| Study group | Role | What they receive |
|---|---|---|
| multi-port VATS | Other | Multi-port VATS is an operative method Receives: Procedure: multi-port VATS |
| single-port VATS | Other | Single-port VATS is an operative method Receives: Procedure: single-port VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Numerical Rating Scale (NRS) or Wong-Baker Face Pain Rating Scale
Measured: beginning at 3 hours after surgery until 5 days
Secondary outcomes (11)
Complication
Yes/No
Measured: beginning at 3 hours after surgery until 30 days
Mean arterial pressure
MAP; mmHg
Measured: beginning 20 min before the start of surgery until 20 min after the surgery.
Heart rate
HR; beats per min [bpm]
Measured: beginning 20 min before the start of surgery until 20 min after the surgery.
Cardiac index
CI; L/[min·m2]
Measured: beginning 20 min before the start of surgery until 20 min after the surgery.
Systemic vascular resistance index
SVRI; [dyn·s]/[cm-5·m2]
Measured: beginning 20 min before the start of surgery until 20 min after the surgery.
Global end-diastolic volume index
GEDVI; mL/m2
Measured: beginning 20 min before the start of surgery until 20 min after the surgery.
Leukocyte subset analysis
10^3/ul
Measured: preoperation till 5 days after surgery
Intracellular oxidative activity of neutrophils
ratio compared with preoperation
Measured: preoperation till 5 days after surgery
Inducible nitric oxide synthase expression in monocytes
Arbitrary intensity
Measured: preoperation till 5 days after surgery
Interleukin-6
pg/ml
Measured: preoperation till 5 days after surgery
C-reactive protein
ng/ml
Measured: preoperation till 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Video-Assisted Thoracic SurgeryStudies of the same condition, open and under way.
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun-Hen Liu, Principal investigator, Chang Gung Memorial HospitalHung-Pin Liu, Principal investigator, Chang Gung Memorial HospitalYi-Cheng Wu, Principal investigator, Chang Gung Memorial HospitalMing-Ju Hsieh, Principal investigator, Chang Gung Memorial HospitalWei-Hsun Chen, Principal investigator, Chang Gung Memorial HospitalYen Chu, Principal investigator, Chang Gung Memorial HospitalChien-Ying Liu, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647775
- Sponsor's protocol ID
- CGMH-IRB-104-7159A3
- Status last verified
- Jan 2020
- First submitted
- 28 Dec 2015
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Publications
Nagahiro I, Andou A, Aoe M, Sano Y, Date H, Shimizu N. Pulmonary function, postoperative pain, and serum cytokine level after lobectomy: a comparison of VATS and conventional procedure. Ann Thorac Surg. 2001 Aug;72(2):362-5. doi: 10.1016/s0003-4975(01)02804-1.
PubMed 11515867Flores RM, Park BJ, Dycoco J, Aronova A, Hirth Y, Rizk NP, Bains M, Downey RJ, Rusch VW. Lobectomy by video-assisted thoracic surgery (VATS) versus thoracotomy for lung cancer. J Thorac Cardiovasc Surg. 2009 Jul;138(1):11-8. doi: 10.1016/j.jtcvs.2009.03.030.
PubMed 19577048Onaitis MW, Petersen RP, Balderson SS, Toloza E, Burfeind WR, Harpole DH Jr, D'Amico TA. Thoracoscopic lobectomy is a safe and versatile procedure: experience with 500 consecutive patients. Ann Surg. 2006 Sep;244(3):420-5. doi: 10.1097/01.sla.0000234892.79056.63.
PubMed 16926568Sihoe AD, Au SS, Cheung ML, Chow IK, Chu KM, Law CY, Wan M, Yim AP. Incidence of chest wall paresthesia after video-assisted thoracic surgery for primary spontaneous pneumothorax. Eur J Cardiothorac Surg. 2004 Jun;25(6):1054-8. doi: 10.1016/j.ejcts.2004.02.018.
PubMed 15145009Rocco G, Martin-Ucar A, Passera E. Uniportal VATS wedge pulmonary resections. Ann Thorac Surg. 2004 Feb;77(2):726-8. doi: 10.1016/S0003-4975(03)01219-0.
PubMed 14759479Gonzalez-Rivas D, Fieira E, Mendez L, Garcia J. Single-port video-assisted thoracoscopic anatomic segmentectomy and right upper lobectomy. Eur J Cardiothorac Surg. 2012 Dec;42(6):e169-71. doi: 10.1093/ejcts/ezs482. Epub 2012 Aug 24.
PubMed 22922693Gonzalez-Rivas D, de la Torre M, Fernandez R, Garcia J. Video: Single-incision video-assisted thoracoscopic right pneumonectomy. Surg Endosc. 2012 Jul;26(7):2078-9. doi: 10.1007/s00464-011-2127-x. Epub 2012 Jan 11.
PubMed 22234590Gonzalez-Rivas D, Fieira E, Delgado M, de la Torre M, Mendez L, Fernandez R. Uniportal video-assisted thoracoscopic sleeve lobectomy and other complex resections. J Thorac Dis. 2014 Oct;6(Suppl 6):S674-81. doi: 10.3978/j.issn.2072-1439.2014.09.17.
PubMed 25379210Wang BY, Liu CY, Hsu PK, Shih CS, Liu CC. Single-incision versus multiple-incision thoracoscopic lobectomy and segmentectomy: a propensity-matched analysis. Ann Surg. 2015 Apr;261(4):793-9. doi: 10.1097/SLA.0000000000000712.
PubMed 24836148Ocakcioglu I, Alpay L, Demir M, Kiral H, Akyil M, Dogruyol T, Tezel C, Baysungur V, Yalcinkaya I. Is single port enough in minimally surgery for pneumothorax? Surg Endosc. 2016 Jan;30(1):59-64. doi: 10.1007/s00464-015-4161-6. Epub 2015 Mar 24.
PubMed 25801108Swanstrom LL, Kurian A, Dunst CM, Sharata A, Bhayani N, Rieder E. Long-term outcomes of an endoscopic myotomy for achalasia: the POEM procedure. Ann Surg. 2012 Oct;256(4):659-67. doi: 10.1097/SLA.0b013e31826b5212.
PubMed 22982946Ujiki MB, Yetasook AK, Zapf M, Linn JG, Carbray JM, Denham W. Peroral endoscopic myotomy: A short-term comparison with the standard laparoscopic approach. Surgery. 2013 Oct;154(4):893-7; discussion 897-900. doi: 10.1016/j.surg.2013.04.042.
PubMed 24074429Liu YH, Chu Y, Wu YC, Yeh CJ, Liu CY, Hsieh MJ, Yuan HC, Ko PJ, Liu HP. Natural orifice surgery in thoracic surgery. J Thorac Dis. 2014 Jan;6(1):61-3. doi: 10.3978/j.issn.2072-1439.2014.01.02. No abstract available.
PubMed 24455178Takata M, Watanabe G, Ushijima T, Ishikawa N. A novel internal thoracic artery harvesting technique via subxiphoid approach--for the least invasive coronary artery bypass grafting. Interact Cardiovasc Thorac Surg. 2009 Nov;9(5):891-2. doi: 10.1510/icvts.2009.212282. Epub 2009 Aug 31.
PubMed 19720658St Peter SD, Sharp SW, Ostlie DJ, Snyder CL, Holcomb GW 3rd, Sharp RJ. Use of a subxiphoid incision for pectus bar placement in the repair of pectus excavatum. J Pediatr Surg. 2010 Jun;45(6):1361-4. doi: 10.1016/j.jpedsurg.2010.02.115.
PubMed 20620345
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic and Inflammatory Responses in Thoracic Surgery: Hemodynamic and Inflammatory Responses Following Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT02647775
- Acronym / sponsor ID
- CGMH-IRB-104-7159A3
- Conditions
- Video-Assisted Thoracic Surgery
- Keywords
- Thoracoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Jan 2016 (estimated)
- 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.
Video-assisted thoracoscopic surgery (VATS) for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy. The specific aims of this project are: to clarify the physiologic and immunologic effects of different approaches for minimally invasive thoracic surgery: (1) multiple-port VATS; (2) single-port VATS
Detailed description
Video-assisted thoracoscopic surgery (VATS) was first reported in the early 1990s. Since then, the safety and efficacy of thoracoscopy for diagnosing and treating pleural, pulmonary, and mediastinal disease has been demonstrated with similar oncological results, which were confirmed by multiple clinical studies. Although VATS for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy, unfortunately chronic thoracic wound discomfort and postoperative neuralgia were found in a significant portion of patients .
Recently, a minimally invasive approach that is different from the conventional multiport thoracoscopic technique is gradually becoming of great interest in the diagnosis and treatment of thoracic surgical disease. Single-port VATS is one of the most promising emerging surgical techniques which allows the surgeon to perform a majority of thoracic surgeries and with similar perioperative outcomes that are comparable with the conventional multiport technique. However, a very limited number of clinical studies have demonstrated the advantages of single port VATS in postoperative pain reduction, when comparing to the traditional multiport thoracoscopic approach.
To clarify the physiologic and immunologic effects of different approaches for minimally invasive thoracic surgery, investigators aim to compare the perioperative physiological changes, immunological responses, and postoperative pain between standard (multi-port) transthoracic thoracoscopic and single-port transthoracic thoracoscopic surgery for thoracic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multi-port VATS | Other | Procedure: multi-port VATSMulti-port VATS is an operative method |
| single-port VATS | Other | Procedure: single-port VATSSingle-port VATS is an operative method |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with thoracic surgical diseases(lung cancer. mediastinal tumor. solitary pulmonary lesion. pneumothorax) who will be underwent video-assisted thoracic surgery
Key exclusion criteria (4 listed)
- Unresectable mediastinal tumor
- Previous history of ipsilateral pulmonary resection
- Patients with complex cardiopulmonary dysfunction
- Unresectable pulmonary hilar tumor
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 |
|---|---|---|
| multi-port VATSPatients with thoracic surgical diseases who underwent VATS will be recruited into this study to investigate the postoperative pain , physiologic and immunologic impacts of two different approaches for minimally invasive thoracic surgery. | Procedure or surgery | multi-port VATS |
| single-port VATSPatients with thoracic surgical diseases who underwent VATS will be recruited into this study to investigate the postoperative pain , physiologic and immunologic impacts of two different approaches for minimally invasive thoracic surgery. | Procedure or surgery | single-port VATS |
Primary outcome
Pain score
Time frame: beginning at 3 hours after surgery until 5 days
Numerical Rating Scale (NRS) or Wong-Baker Face Pain Rating Scale
11 secondary outcomes
Complication
Time frame: beginning at 3 hours after surgery until 30 days
Mean arterial pressure
Time frame: beginning 20 min before the start of surgery until 20 min after the surgery.
Heart rate
Time frame: beginning 20 min before the start of surgery until 20 min after the surgery.
Cardiac index
Time frame: beginning 20 min before the start of surgery until 20 min after the surgery.
Systemic vascular resistance index
Time frame: beginning 20 min before the start of surgery until 20 min after the surgery.
Global end-diastolic volume index
Time frame: beginning 20 min before the start of surgery until 20 min after the surgery.
Leukocyte subset analysis
Time frame: preoperation till 5 days after surgery
Intracellular oxidative activity of neutrophils
Time frame: preoperation till 5 days after surgery
Inducible nitric oxide synthase expression in monocytes
Time frame: preoperation till 5 days after surgery
Interleukin-6
Time frame: preoperation till 5 days after surgery
C-reactive protein
Time frame: preoperation till 5 days after surgery
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 22 Jan 2020.
- Background: PubMed 11515867Nagahiro I, Andou A, Aoe M, Sano Y, Date H, Shimizu N. Pulmonary function, postoperative pain, and serum cytokine level after lobectomy: a comparison of VATS and conventional procedure. Ann Thorac Surg. 2001 Aug;72(2):362-5. doi: 10.1016/s0003-4975(01)02804-1.
- Background: PubMed 19577048Flores RM, Park BJ, Dycoco J, Aronova A, Hirth Y, Rizk NP, Bains M, Downey RJ, Rusch VW. Lobectomy by video-assisted thoracic surgery (VATS) versus thoracotomy for lung cancer. J Thorac Cardiovasc Surg. 2009 Jul;138(1):11-8. doi: 10.1016/j.jtcvs.2009.03.030.
- Background: PubMed 16926568Onaitis MW, Petersen RP, Balderson SS, Toloza E, Burfeind WR, Harpole DH Jr, D'Amico TA. Thoracoscopic lobectomy is a safe and versatile procedure: experience with 500 consecutive patients. Ann Surg. 2006 Sep;244(3):420-5. doi: 10.1097/01.sla.0000234892.79056.63.
- Background: PubMed 15145009Sihoe AD, Au SS, Cheung ML, Chow IK, Chu KM, Law CY, Wan M, Yim AP. Incidence of chest wall paresthesia after video-assisted thoracic surgery for primary spontaneous pneumothorax. Eur J Cardiothorac Surg. 2004 Jun;25(6):1054-8. doi: 10.1016/j.ejcts.2004.02.018.
- Background: PubMed 14759479Rocco G, Martin-Ucar A, Passera E. Uniportal VATS wedge pulmonary resections. Ann Thorac Surg. 2004 Feb;77(2):726-8. doi: 10.1016/S0003-4975(03)01219-0.
- Background: PubMed 22922693Gonzalez-Rivas D, Fieira E, Mendez L, Garcia J. Single-port video-assisted thoracoscopic anatomic segmentectomy and right upper lobectomy. Eur J Cardiothorac Surg. 2012 Dec;42(6):e169-71. doi: 10.1093/ejcts/ezs482. Epub 2012 Aug 24.
- Background: PubMed 22234590Gonzalez-Rivas D, de la Torre M, Fernandez R, Garcia J. Video: Single-incision video-assisted thoracoscopic right pneumonectomy. Surg Endosc. 2012 Jul;26(7):2078-9. doi: 10.1007/s00464-011-2127-x. Epub 2012 Jan 11.
- Background: PubMed 25379210Gonzalez-Rivas D, Fieira E, Delgado M, de la Torre M, Mendez L, Fernandez R. Uniportal video-assisted thoracoscopic sleeve lobectomy and other complex resections. J Thorac Dis. 2014 Oct;6(Suppl 6):S674-81. doi: 10.3978/j.issn.2072-1439.2014.09.17.
- Background: PubMed 24836148Wang BY, Liu CY, Hsu PK, Shih CS, Liu CC. Single-incision versus multiple-incision thoracoscopic lobectomy and segmentectomy: a propensity-matched analysis. Ann Surg. 2015 Apr;261(4):793-9. doi: 10.1097/SLA.0000000000000712.
- Background: PubMed 25801108Ocakcioglu I, Alpay L, Demir M, Kiral H, Akyil M, Dogruyol T, Tezel C, Baysungur V, Yalcinkaya I. Is single port enough in minimally surgery for pneumothorax? Surg Endosc. 2016 Jan;30(1):59-64. doi: 10.1007/s00464-015-4161-6. Epub 2015 Mar 24.
- Background: PubMed 22982946Swanstrom LL, Kurian A, Dunst CM, Sharata A, Bhayani N, Rieder E. Long-term outcomes of an endoscopic myotomy for achalasia: the POEM procedure. Ann Surg. 2012 Oct;256(4):659-67. doi: 10.1097/SLA.0b013e31826b5212.
- Background: PubMed 24074429Ujiki MB, Yetasook AK, Zapf M, Linn JG, Carbray JM, Denham W. Peroral endoscopic myotomy: A short-term comparison with the standard laparoscopic approach. Surgery. 2013 Oct;154(4):893-7; discussion 897-900. doi: 10.1016/j.surg.2013.04.042.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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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.
Yun-Hen Liu principal investigator
Chang Gung Memorial Hospital
Hung-Pin Liu principal investigator
Chang Gung Memorial Hospital
Yi-Cheng Wu 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 multi-port VATS and single-port VATS in people with Video-Assisted Thoracic Surgery, 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 22 Jan 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?
Pain score (time frame: beginning at 3 hours after surgery until 5 days). 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 NCT02647775, which also lists 33 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 22 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.