Esophageal CancerNCT02457299
Esophagectomy With or Without Prior Ischemic Gastric Preconditioning
A study testing Two Stage Esophagectomy and One Stage Esophagectomy in people with Esophageal Cancer, run by Endeavor Health at 1 site in United States.
Trial summary
This multi-center, randomized prospective clinical trial involves esophageal cancer patients who are surgical candidates. Patients will be randomized either to the one stage or the two stage esophagectomy procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Two Stage Esophagectomy and One Stage Esophagectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Nov 2016
- 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
- Subject is willing and able to provide written informed consent
- Subject is a candidate for esophagectomy with or without gastric pre-conditioning procedure per thoracic surgeon
- Patient is at least 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Cancer stage: T1-2-3 N0M0, Locally advanced, T2-3 N1M0 based on American Joint Committee on Cancer (AJCC) 7th Edition by the oncologist
- No definitive radiological evidence of distant metastases as evaluated by CT or PET/CT scan
- Subject is willing and able to comply with the study procedures and complete the entire study as specified in the protocol, including follow-up visits.
Who cannot join
- Patients < 18 years old
- History of invasive cancer within the past 5 years, (exceptions: non melanoma skin cancer, in situ cancers)
- Prior upper abdominal surgeries performed open and/or laparoscopic; such as but not limited to Nissen fundoplication, gastrectomy, bariatric surgery, hiatus hernia repair.
- Subject is participating in another investigational trial
- Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding
- Subject is part of the site personnel directly involved with this study
- Subject is a family member of the investigational study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: A Multicenter, Randomized Trial of Esophagectomy and Cervical Esophagogastrostomy With (Two-stage) or Without (One-stage) Prior Ischemic Gastric Preconditioning by Laparoscopic Ligation of Left Gastric and Short Gastric Arteries
This multi-center, randomized prospective clinical trial involves esophageal cancer patients who are surgical candidates. Patients will be randomized either to the one stage or the two stage esophagectomy procedure. Surgical, oncology outcomes, quality of life and cost analysis from both types of procedure will be reviewed and compared.
Read the detailed description
Esophagectomy with gastric pull-up reconstruction is the current preferred operation for either benign or malignant esophageal disease requiring resection. One of the major complications of an esophagectomy with gastric pull-up reconstruction is esophagus-stomach connection (gastric conduit) failure, which carries significant morbidity and mortality. Many factors contribute to the development of gastric conduit failure, but relative decreased blood flow (ischemia) of the tip of the gastric conduit is believed to be one major factor. This is due to the sacrifice of 3 of the 5 gastric blood supplies leaving the tip of the conduit to rely on collateral vessels. In an effort to improve perfusion to the gastric conduit and to minimize ischemia, the relatively novel approach of ischemic gastric preconditioning was devised, but without concrete evidence to show an advantage of a reduction in gastric conduit failures.
Patients meeting eligibility criteria and agree to participation in the study will be randomized to either a esophagectomy with (two-stage) or without (one-stage) ischemic gastric preconditioning and the incidence of gastric conduit failure will be compared. Those randomized to a two-stage procedure will have laparoscopic staging and ischemic gastric conditioning and pyloric Botox injection done 7-10 days prior to an esophagectomy and those randomized to a one-stage procedure will only have the esophagectomy performed.
Validated quality of life (QOL) questionnaires will be completed at the preoperative visit as well as on the day of discharge and at postoperative follow-up timepoints: 3 weeks, 3 months, 6 months, 12 months and 24 months. Data collection will be mostly collected through electronic medical record review and will include, but is not limited to: demographic data; imaging and laboratory values; past medical, surgical and social history; inpatient and intraoperative data; and vitals signs. Patients will be assessed for adverse events throughout study participation.
- Conditions
- Esophageal Cancer
- Being tested
- Two Stage Esophagectomy, One Stage Esophagectomy
- Keywords
- Esophagectomy, Gastric Conduit, Esophageal Cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two Stage EsophagectomyProcedure or surgery
Patients will undergo laparoscopic staging and ischemic gastric conditioning and pyloric Botox injection 7-10 days prior to an esophagectomy with gastric pull-up reconstruction
One Stage EsophagectomyProcedure or surgery
Patients will undergo an esophagectomy with gastric pull-up reconstruction without any preconditioning.
| Study group | Role | What they receive |
|---|---|---|
| Two Stage Esophagectomy | Active comparator | Ischemic gastric preconditioning performed 7-10 prior to esophagectomy Receives: Procedure: Two Stage Esophagectomy |
| One Stage Esophagectomy | Active comparator | Esophagectomy alone Receives: Procedure: One Stage Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with gastric conduit failures as a measure of safety and tolerability in the one-stage esophagectomy as compared with the two-stage esophagectomy.
Measured: 7-10 days
Secondary outcomes (4)
Mortality rates in both groups
Measured: 30-90 days
Cost effectiveness analysis of treatment in one-stage versus two-stage esophagectomy
Measured: Hospital inpatient stay, an expected average of a week
Nutritional status of one-stage versus two-stage esophagectomy
This will be determined by prealbumin and albumin values
Measured: Within 30-days of surgery as compared with 3 and 12 month follow-up time points
Quality of Life (QOL) scores of patients in both arms
Measured: baseline and up to 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Standard of care was modified at the primary institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ki Wan Kim, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457299
- Sponsor's protocol ID
- EH15-175
- Status last verified
- Aug 2019
- First submitted
- 21 Apr 2015
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wormuth JK, Heitmiller RF. Esophageal conduit necrosis. Thorac Surg Clin. 2006 Feb;16(1):11-22. doi: 10.1016/j.thorsurg.2006.01.003.
PubMed 16696279Honkoop P, Siersema PD, Tilanus HW, Stassen LP, Hop WC, van Blankenstein M. Benign anastomotic strictures after transhiatal esophagectomy and cervical esophagogastrostomy: risk factors and management. J Thorac Cardiovasc Surg. 1996 Jun;111(6):1141-6; discussion 1147-8. doi: 10.1016/s0022-5223(96)70215-5.
PubMed 8642814Cooke DT, Lin GC, Lau CL, Zhang L, Si MS, Lee J, Chang AC, Pickens A, Orringer MB. Analysis of cervical esophagogastric anastomotic leaks after transhiatal esophagectomy: risk factors, presentation, and detection. Ann Thorac Surg. 2009 Jul;88(1):177-84; discussion 184-5. doi: 10.1016/j.athoracsur.2009.03.035.
PubMed 19559221Yetasook AK, Leung D, Howington JA, Talamonti MS, Zhao J, Carbray JM, Ujiki MB. Laparoscopic ischemic conditioning of the stomach prior to esophagectomy. Dis Esophagus. 2013 Jul;26(5):479-86. doi: 10.1111/j.1442-2050.2012.01374.x. Epub 2012 Jul 20.
PubMed 22816598Urschel JD. Ischemic conditioning of the rat stomach: implications for esophageal replacement with stomach. J Cardiovasc Surg (Torino). 1995 Apr;36(2):191-3.
PubMed 7790342Reavis KM, Chang EY, Hunter JG, Jobe BA. Utilization of the delay phenomenon improves blood flow and reduces collagen deposition in esophagogastric anastomoses. Ann Surg. 2005 May;241(5):736-45; discussion 745-7. doi: 10.1097/01.sla.0000160704.50657.32.
PubMed 15849509Cuenca-Abente F, Assalia A, del Genio G, Rogula T, Nocca D, Ueda K, Gagner M. Laparoscopic partial gastric transection and devascularization in order to enhance its flow. Ann Surg Innov Res. 2008 Jul 7;2:3. doi: 10.1186/1750-1164-2-3.
PubMed 18606017Akiyama S, Kodera Y, Sekiguchi H, Kasai Y, Kondo K, Ito K, Takagi H. Preoperative embolization therapy for esophageal operation. J Surg Oncol. 1998 Dec;69(4):219-23. doi: 10.1002/(sici)1096-9098(199812)69:43.0.co;2-7.
PubMed 9881938Bludau M, Holscher AH, Vallbohmer D, Gutschow C, Schroder W. Ischemic conditioning of the gastric conduit prior to esophagectomy improves mucosal oxygen saturation. Ann Thorac Surg. 2010 Oct;90(4):1121-6. doi: 10.1016/j.athoracsur.2010.06.003.
PubMed 20868800Oezcelik A, Banki F, DeMeester SR, Leers JM, Ayazi S, Abate E, Hagen JA, Lipham JC, DeMeester TR. Delayed esophagogastrostomy: a safe strategy for management of patients with ischemic gastric conduit at time of esophagectomy. J Am Coll Surg. 2009 Jun;208(6):1030-4. doi: 10.1016/j.jamcollsurg.2009.02.055. Epub 2009 Apr 24.
PubMed 19476888Holscher AH, Schneider PM, Gutschow C, Schroder W. Laparoscopic ischemic conditioning of the stomach for esophageal replacement. Ann Surg. 2007 Feb;245(2):241-6. doi: 10.1097/01.sla.0000245847.40779.10.
PubMed 17245177Nguyen NT, Longoria M, Sabio A, Chalifoux S, Lee J, Chang K, Wilson SE. Preoperative laparoscopic ligation of the left gastric vessels in preparation for esophagectomy. Ann Thorac Surg. 2006 Jun;81(6):2318-20. doi: 10.1016/j.athoracsur.2005.05.033.
PubMed 16731189Schroder W, Holscher AH, Bludau M, Vallbohmer D, Bollschweiler E, Gutschow C. Ivor-Lewis esophagectomy with and without laparoscopic conditioning of the gastric conduit. World J Surg. 2010 Apr;34(4):738-43. doi: 10.1007/s00268-010-0403-x.
PubMed 20098986Sepesi B, Swisher SG, Walsh GL, Correa A, Mehran RJ, Rice D, Roth J, Vaporciyan A, Hofstetter WL. Omental reinforcement of the thoracic esophagogastric anastomosis: an analysis of leak and reintervention rates in patients undergoing planned and salvage esophagectomy. J Thorac Cardiovasc Surg. 2012 Nov;144(5):1146-50. doi: 10.1016/j.jtcvs.2012.07.085. Epub 2012 Aug 28.
PubMed 22939861Varela E, Reavis KM, Hinojosa MW, Nguyen N. Laparoscopic gastric ischemic conditioning prior to esophagogastrectomy: technique and review. Surg Innov. 2008 Jun;15(2):132-5. doi: 10.1177/1553350608317352. Epub 2008 May 13.
PubMed 18480085
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Trial of Esophagectomy and Cervical Esophagogastrostomy With (Two-stage) or Without (One-stage) Prior Ischemic Gastric Preconditioning by Laparoscopic Ligation of Left Gastric and Short Gastric Arteries
- ClinicalTrials.gov ID
- NCT02457299
- Acronym / sponsor ID
- EH15-175
- Conditions
- Esophageal Cancer
- Keywords
- Esophagectomy, Gastric Conduit, Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Standard of care was modified at the primary institution
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 May 2015 (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.
This multi-center, randomized prospective clinical trial involves esophageal cancer patients who are surgical candidates. Patients will be randomized either to the one stage or the two stage esophagectomy procedure. Surgical, oncology outcomes, quality of life and cost analysis from both types of procedure will be reviewed and compared.
Detailed description
Esophagectomy with gastric pull-up reconstruction is the current preferred operation for either benign or malignant esophageal disease requiring resection. One of the major complications of an esophagectomy with gastric pull-up reconstruction is esophagus-stomach connection (gastric conduit) failure, which carries significant morbidity and mortality. Many factors contribute to the development of gastric conduit failure, but relative decreased blood flow (ischemia) of the tip of the gastric conduit is believed to be one major factor. This is due to the sacrifice of 3 of the 5 gastric blood supplies leaving the tip of the conduit to rely on collateral vessels. In an effort to improve perfusion to the gastric conduit and to minimize ischemia, the relatively novel approach of ischemic gastric preconditioning was devised, but without concrete evidence to show an advantage of a reduction in gastric conduit failures.
Patients meeting eligibility criteria and agree to participation in the study will be randomized to either a esophagectomy with (two-stage) or without (one-stage) ischemic gastric preconditioning and the incidence of gastric conduit failure will be compared. Those randomized to a two-stage procedure will have laparoscopic staging and ischemic gastric conditioning and pyloric Botox injection done 7-10 days prior to an esophagectomy and those randomized to a one-stage procedure will only have the esophagectomy performed.
Validated quality of life (QOL) questionnaires will be completed at the preoperative visit as well as on the day of discharge and at postoperative follow-up timepoints: 3 weeks, 3 months, 6 months, 12 months and 24 months. Data collection will be mostly collected through electronic medical record review and will include, but is not limited to: demographic data; imaging and laboratory values; past medical, surgical and social history; inpatient and intraoperative data; and vitals signs. Patients will be assessed for adverse events throughout study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two Stage Esophagectomy | Active comparator | Procedure: Two Stage EsophagectomyIschemic gastric preconditioning performed 7-10 prior to esophagectomy |
| One Stage Esophagectomy | Active comparator | Procedure: One Stage EsophagectomyEsophagectomy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is willing and able to provide written informed consent
- Subject is a candidate for esophagectomy with or without gastric pre-conditioning procedure per thoracic surgeon
- Patient is at least 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Cancer stage: T1-2-3 N0M0, Locally advanced, T2-3 N1M0 based on American Joint Committee on Cancer (AJCC) 7th Edition by the oncologist
Key exclusion criteria (7 listed)
- Patients < 18 years old
- History of invasive cancer within the past 5 years, (exceptions: non melanoma skin cancer, in situ cancers)
- Prior upper abdominal surgeries performed open and/or laparoscopic; such as but not limited to Nissen fundoplication, gastrectomy, bariatric surgery, hiatus hernia repair.
- Subject is participating in another investigational trial
- Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding
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 |
|---|---|---|
| Two Stage EsophagectomyPatients will undergo laparoscopic staging and ischemic gastric conditioning and pyloric Botox injection 7-10 days prior to an esophagectomy with gastric pull-up reconstruction | Procedure or surgery | Two Stage Esophagectomy |
| One Stage EsophagectomyPatients will undergo an esophagectomy with gastric pull-up reconstruction without any preconditioning. | Procedure or surgery | One Stage Esophagectomy |
Primary outcome
The number of participants with gastric conduit failures as a measure of safety and tolerability in the one-stage esophagectomy as compared with the two-stage esophagectomy.
Time frame: 7-10 days
4 secondary outcomes
Mortality rates in both groups
Time frame: 30-90 days
Cost effectiveness analysis of treatment in one-stage versus two-stage esophagectomy
Time frame: Hospital inpatient stay, an expected average of a week
Nutritional status of one-stage versus two-stage esophagectomy
Time frame: Within 30-days of surgery as compared with 3 and 12 month follow-up time points
Quality of Life (QOL) scores of patients in both arms
Time frame: baseline and up to 24 months postoperatively
Results and safety
The study was stopped early (reason given: Standard of care was modified at the primary institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Background: PubMed 16696279Wormuth JK, Heitmiller RF. Esophageal conduit necrosis. Thorac Surg Clin. 2006 Feb;16(1):11-22. doi: 10.1016/j.thorsurg.2006.01.003.
- Background: PubMed 8642814Honkoop P, Siersema PD, Tilanus HW, Stassen LP, Hop WC, van Blankenstein M. Benign anastomotic strictures after transhiatal esophagectomy and cervical esophagogastrostomy: risk factors and management. J Thorac Cardiovasc Surg. 1996 Jun;111(6):1141-6; discussion 1147-8. doi: 10.1016/s0022-5223(96)70215-5.
- Background: PubMed 19559221Cooke DT, Lin GC, Lau CL, Zhang L, Si MS, Lee J, Chang AC, Pickens A, Orringer MB. Analysis of cervical esophagogastric anastomotic leaks after transhiatal esophagectomy: risk factors, presentation, and detection. Ann Thorac Surg. 2009 Jul;88(1):177-84; discussion 184-5. doi: 10.1016/j.athoracsur.2009.03.035.
- Background: PubMed 22816598Yetasook AK, Leung D, Howington JA, Talamonti MS, Zhao J, Carbray JM, Ujiki MB. Laparoscopic ischemic conditioning of the stomach prior to esophagectomy. Dis Esophagus. 2013 Jul;26(5):479-86. doi: 10.1111/j.1442-2050.2012.01374.x. Epub 2012 Jul 20.
- Background: PubMed 7790342Urschel JD. Ischemic conditioning of the rat stomach: implications for esophageal replacement with stomach. J Cardiovasc Surg (Torino). 1995 Apr;36(2):191-3.
- Background: PubMed 15849509Reavis KM, Chang EY, Hunter JG, Jobe BA. Utilization of the delay phenomenon improves blood flow and reduces collagen deposition in esophagogastric anastomoses. Ann Surg. 2005 May;241(5):736-45; discussion 745-7. doi: 10.1097/01.sla.0000160704.50657.32.
- Background: PubMed 18606017Cuenca-Abente F, Assalia A, del Genio G, Rogula T, Nocca D, Ueda K, Gagner M. Laparoscopic partial gastric transection and devascularization in order to enhance its flow. Ann Surg Innov Res. 2008 Jul 7;2:3. doi: 10.1186/1750-1164-2-3.
- Background: PubMed 9881938Akiyama S, Kodera Y, Sekiguchi H, Kasai Y, Kondo K, Ito K, Takagi H. Preoperative embolization therapy for esophageal operation. J Surg Oncol. 1998 Dec;69(4):219-23. doi: 10.1002/(sici)1096-9098(199812)69:43.0.co;2-7.
- Background: PubMed 20868800Bludau M, Holscher AH, Vallbohmer D, Gutschow C, Schroder W. Ischemic conditioning of the gastric conduit prior to esophagectomy improves mucosal oxygen saturation. Ann Thorac Surg. 2010 Oct;90(4):1121-6. doi: 10.1016/j.athoracsur.2010.06.003.
- Background: PubMed 19476888Oezcelik A, Banki F, DeMeester SR, Leers JM, Ayazi S, Abate E, Hagen JA, Lipham JC, DeMeester TR. Delayed esophagogastrostomy: a safe strategy for management of patients with ischemic gastric conduit at time of esophagectomy. J Am Coll Surg. 2009 Jun;208(6):1030-4. doi: 10.1016/j.jamcollsurg.2009.02.055. Epub 2009 Apr 24.
- Background: PubMed 17245177Holscher AH, Schneider PM, Gutschow C, Schroder W. Laparoscopic ischemic conditioning of the stomach for esophageal replacement. Ann Surg. 2007 Feb;245(2):241-6. doi: 10.1097/01.sla.0000245847.40779.10.
- Background: PubMed 16731189Nguyen NT, Longoria M, Sabio A, Chalifoux S, Lee J, Chang K, Wilson SE. Preoperative laparoscopic ligation of the left gastric vessels in preparation for esophagectomy. Ann Thorac Surg. 2006 Jun;81(6):2318-20. doi: 10.1016/j.athoracsur.2005.05.033.
- Individual participant dataSharing planned: No
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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.
Ki Wan Kim, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two Stage Esophagectomy and One Stage Esophagectomy in people with Esophageal Cancer, run by Endeavor Health at 1 site in United States.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Aug 2019. 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 United States. 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 was stopped early (reason given: Standard of care was modified at the primary institution). Results are not available in the source record.
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?
The number of participants with gastric conduit failures as a measure of safety and tolerability in the one-stage esophagectomy as compared with the two-stage esophagectomy. (time frame: 7-10 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 NCT02457299, which also lists 15 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 5 Aug 2019.