Pancreatic NeoplasmsWESP-PSMNCT04605042
Comparsion of WT and SNP Techniques of EUS-FNB in Pancreatic Solid Mass (WESP-PSM)
A study testing wet suction and standard negative pressure suction in people with Pancreatic Neoplasms and Diagnoses Disease, run by Ruijin Hospital.
Trial summary
The purpose of this study is to compare the diagnosis accuracy between of wet suction (WS) technique and standard negative pressure (SNP) technique in EUS-FNB by 22G EUS Procore fine needle biopsy（FNB）device for solid pancreatic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Diagnoses Disease
- What is being tested?
- wet suction and standard negative pressure suction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 30 Sep 2022
- 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
- informed consent
- Subjects over 18 years old
- Imaging examination (ultrasound, CT or MRI) diagnosed or suspected solid pancreatic mass more than 1cm
Who cannot join
- Unable or refused to sign informed consent
- suspended anticoagulant/antiplatelet therapy
- Being pregnant or breastfeeding
- Cystic lesions of the pancreas
- coagulation disorders (PLT <50×103/ L, INR > 1.5)
- A history of mental illness
- other medical conditions that are not suitable for FNB puncture
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Prospective Clinical Study of Wet-suction Technique and Standard Negative Pressure Technique in EUS-FNB for the Diagnosis of Pancreatic Solid Mass
The purpose of this study is to compare the diagnosis accuracy between of wet suction (WS) technique and standard negative pressure (SNP) technique in EUS-FNB by 22G EUS Procore fine needle biopsy（FNB）device for solid pancreatic lesions.
Read the detailed description
This is a multi-center, single-blind, randomized, controlled trial. two hundred and ninety six patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to two groups. For group A which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is WS-SNP-WS-SNP technique. For group B with 22G EUS Procore fine needle biopsy device, the pass sequence is SNP-WS-SNP-WS. All procedures will be performed by experienced echo-endoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.
- Conditions
- Pancreatic Neoplasms, Diagnoses Disease
- Being tested
- wet suction, standard negative pressure suction
- Keywords
- endoscopic ultrasound, endoscopic ultrasound guided FNB
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wet suctionProcedure or surgery
Before pucturing the lesion, the stylet was removed and the needle was pre-flushed with 1-2 mL of saline using a 10-mL syringe, the endoscopist then punctured the lesion and replaced the 10-mL syringe with a 10-mL pre-vacuum syringe
standard negative pressure suctionProcedure or surgery
after puncturing the lesion, the endoscopist removed the stylet and attached a 10-mL pre-vacuum syringe for aspiration.
| Study group | Role | What they receive |
|---|---|---|
| WET First group | Experimental | COOK ECHO-HD 22-C EchoTip Procore needle biopsy in WS-SNP-WS-SNP sequence Receives: Procedure: wet suction; Procedure: standard negative pressure suction |
| STANDARD first group | Experimental | COOK ECHO-HD 22-C EchoTip Procore needle in SNP-WS-SNP-WS sequence Receives: Procedure: wet suction; Procedure: standard negative pressure suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic sensitivity of WS technique and SNP technique by EUS-FNB
Sensitivity will be calculated as the probability of actually having pancreatic diasease and being diagnosed by WS technique during EUS-FNB
Measured: 6 month
diagnostic specificity of WS technique and SNP technique by EUS-FNB
specificity will be calculated as the probability of actually not having the pancreatic disease and being diagnosed as being free of the disease by WS or SNP technique during EUS-FNB
Measured: 6 month
Secondary outcomes (2)
Sample adequacy of WS technique and SNP technique by EUS-FNB
The tissue integrity assessments of specimens will be evaluated by score 0-3. Score 3, sufficient material for adequate histological interpretation; Score 2, samples allowing limited histological assessment; Score 1,samples not providing histological information.
Measured: 6 month
Cell density of WS technique and SNP technique by EUS-FNB
The Cell density assessments of specimens will be evaluated by score A-C. Score A：Satisfactory, more than 4 clusters of cells, each cluster more than 10 cells.
Score B：Sufficient, approximately 2-4 clusters, each with more than 10 cells Score C: ：Unsatisfactory, less than 2 clusters or no cells on slide
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Second Affiliated Hospital of Soochow University
- Responsible party
- Principal investigator, duowu zou, Ruijin Hospital
- Investigators
- DuoWu Zou, Ph.D,M.D, Study chair, Ruijin hospital Shanghai Jiaotong Universtity, school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605042
- Sponsor's protocol ID
- RuijinH2020301
- Acronym
- WESP-PSM
- Status last verified
- Nov 2020
- First submitted
- 1 Oct 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dumonceau JM, Deprez PH, Jenssen C, Iglesias-Garcia J, Larghi A, Vanbiervliet G, Aithal GP, Arcidiacono PG, Bastos P, Carrara S, Czako L, Fernandez-Esparrach G, Fockens P, Gines A, Havre RF, Hassan C, Vilmann P, van Hooft JE, Polkowski M. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated January 2017. Endoscopy. 2017 Jul;49(7):695-714. doi: 10.1055/s-0043-109021. Epub 2017 May 16.
PubMed 28511234Banafea O, Mghanga FP, Zhao J, Zhao R, Zhu L. Endoscopic ultrasonography with fine-needle aspiration for histological diagnosis of solid pancreatic masses: a meta-analysis of diagnostic accuracy studies. BMC Gastroenterol. 2016 Aug 31;16(1):108. doi: 10.1186/s12876-016-0519-z.
PubMed 27580856Puli SR, Bechtold ML, Buxbaum JL, Eloubeidi MA. How good is endoscopic ultrasound-guided fine-needle aspiration in diagnosing the correct etiology for a solid pancreatic mass?: A meta-analysis and systematic review. Pancreas. 2013 Jan;42(1):20-6. doi: 10.1097/MPA.0b013e3182546e79.
PubMed 23254913Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.
PubMed 23433878Moller K, Papanikolaou IS, Toermer T, Delicha EM, Sarbia M, Schenck U, Koch M, Al-Abadi H, Meining A, Schmidt H, Schulz HJ, Wiedenmann B, Rosch T. EUS-guided FNA of solid pancreatic masses: high yield of 2 passes with combined histologic-cytologic analysis. Gastrointest Endosc. 2009 Jul;70(1):60-9. doi: 10.1016/j.gie.2008.10.008. Epub 2009 Apr 25.
PubMed 19394012Sakamoto H, Kitano M, Komaki T, Noda K, Chikugo T, Dote K, Takeyama Y, Das K, Yamao K, Kudo M. Prospective comparative study of the EUS guided 25-gauge FNA needle with the 19-gauge Trucut needle and 22-gauge FNA needle in patients with solid pancreatic masses. J Gastroenterol Hepatol. 2009 Mar;24(3):384-90. doi: 10.1111/j.1440-1746.2008.05636.x. Epub 2008 Nov 20.
PubMed 19032453Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernandez-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12.
PubMed 28898917Alatawi A, Beuvon F, Grabar S, Leblanc S, Chaussade S, Terris B, Barret M, Prat F. Comparison of 22G reverse-beveled versus standard needle for endoscopic ultrasound-guided sampling of solid pancreatic lesions. United European Gastroenterol J. 2015 Aug;3(4):343-52. doi: 10.1177/2050640615577533.
PubMed 26279842Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.
PubMed 25733127Wang Y, Wang RH, Ding Z, Tan SY, Chen Q, Duan YQ, Zhu LR, Cao JW, Wang J, Shi G, Wu XL, Wang JL, Zhao YC, Tang SJ, Cheng B. Wet- versus dry-suction techniques for endoscopic ultrasound-guided fine-needle aspiration of solid lesions: a multicenter randomized controlled trial. Endoscopy. 2020 Nov;52(11):995-1003. doi: 10.1055/a-1167-2214. Epub 2020 May 15.
PubMed 32413915Li DF, Wang JY, Yang MF, Xiong F, Zhang DG, Xu ZL, Luo MH, Jing ZD, Wang KX, Wang LS, Yao J. Factors associated with diagnostic accuracy, technical success and adverse events of endoscopic ultrasound-guided fine-needle biopsy: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2020 Aug;35(8):1264-1276. doi: 10.1111/jgh.14999. Epub 2020 Feb 23.
PubMed 32003100
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Clinical Study of Wet-suction Technique and Standard Negative Pressure Technique in EUS-FNB for the Diagnosis of Pancreatic Solid Mass
- ClinicalTrials.gov ID
- NCT04605042
- Acronym / sponsor ID
- WESP-PSM / RuijinH2020301
- Conditions
- Pancreatic Neoplasms, Diagnoses Disease
- Keywords
- endoscopic ultrasound, endoscopic ultrasound guided FNB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, Second Affiliated Hospital of Soochow University
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 27 Oct 2020 (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.
The purpose of this study is to compare the diagnosis accuracy between of wet suction (WS) technique and standard negative pressure (SNP) technique in EUS-FNB by 22G EUS Procore fine needle biopsy（FNB）device for solid pancreatic lesions.
Detailed description
This is a multi-center, single-blind, randomized, controlled trial. two hundred and ninety six patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to two groups. For group A which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is WS-SNP-WS-SNP technique. For group B with 22G EUS Procore fine needle biopsy device, the pass sequence is SNP-WS-SNP-WS. All procedures will be performed by experienced echo-endoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WET First group | Experimental | Procedure: wet suction, Procedure: standard negative pressure suctionCOOK ECHO-HD 22-C EchoTip Procore needle biopsy in WS-SNP-WS-SNP sequence |
| STANDARD first group | Experimental | Procedure: wet suction, Procedure: standard negative pressure suctionCOOK ECHO-HD 22-C EchoTip Procore needle in SNP-WS-SNP-WS sequence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- informed consent
- Subjects over 18 years old
- Imaging examination (ultrasound, CT or MRI) diagnosed or suspected solid pancreatic mass more than 1cm
Key exclusion criteria (7 listed)
- Unable or refused to sign informed consent
- suspended anticoagulant/antiplatelet therapy
- Being pregnant or breastfeeding
- Cystic lesions of the pancreas
- coagulation disorders (PLT <50×103/ L, INR > 1.5)
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 |
|---|---|---|
| wet suctionBefore pucturing the lesion, the stylet was removed and the needle was pre-flushed with 1-2 mL of saline using a 10-mL syringe, the endoscopist then punctured the lesion and replaced the 10-mL syringe with a 10-mL pre-vacuum syringe | Procedure or surgery | STANDARD first group, WET First group |
| standard negative pressure suctionafter puncturing the lesion, the endoscopist removed the stylet and attached a 10-mL pre-vacuum syringe for aspiration. | Procedure or surgery | STANDARD first group, WET First group |
Primary outcome
diagnostic sensitivity of WS technique and SNP technique by EUS-FNB
Time frame: 6 month
Sensitivity will be calculated as the probability of actually having pancreatic diasease and being diagnosed by WS technique during EUS-FNB
diagnostic specificity of WS technique and SNP technique by EUS-FNB
Time frame: 6 month
specificity will be calculated as the probability of actually not having the pancreatic disease and being diagnosed as being free of the disease by WS or SNP technique during EUS-FNB
2 secondary outcomes
Sample adequacy of WS technique and SNP technique by EUS-FNB
Time frame: 6 month
Cell density of WS technique and SNP technique by EUS-FNB
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Background: PubMed 28511234Dumonceau JM, Deprez PH, Jenssen C, Iglesias-Garcia J, Larghi A, Vanbiervliet G, Aithal GP, Arcidiacono PG, Bastos P, Carrara S, Czako L, Fernandez-Esparrach G, Fockens P, Gines A, Havre RF, Hassan C, Vilmann P, van Hooft JE, Polkowski M. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated January 2017. Endoscopy. 2017 Jul;49(7):695-714. doi: 10.1055/s-0043-109021. Epub 2017 May 16.
- Background: PubMed 27580856Banafea O, Mghanga FP, Zhao J, Zhao R, Zhu L. Endoscopic ultrasonography with fine-needle aspiration for histological diagnosis of solid pancreatic masses: a meta-analysis of diagnostic accuracy studies. BMC Gastroenterol. 2016 Aug 31;16(1):108. doi: 10.1186/s12876-016-0519-z.
- Background: PubMed 23254913Puli SR, Bechtold ML, Buxbaum JL, Eloubeidi MA. How good is endoscopic ultrasound-guided fine-needle aspiration in diagnosing the correct etiology for a solid pancreatic mass?: A meta-analysis and systematic review. Pancreas. 2013 Jan;42(1):20-6. doi: 10.1097/MPA.0b013e3182546e79.
- Background: PubMed 23433878Lee JK, Choi JH, Lee KH, Kim KM, Shin JU, Lee JK, Lee KT, Jang KT. A prospective, comparative trial to optimize sampling techniques in EUS-guided FNA of solid pancreatic masses. Gastrointest Endosc. 2013 May;77(5):745-51. doi: 10.1016/j.gie.2012.12.009. Epub 2013 Feb 21.
- Background: PubMed 19394012Moller K, Papanikolaou IS, Toermer T, Delicha EM, Sarbia M, Schenck U, Koch M, Al-Abadi H, Meining A, Schmidt H, Schulz HJ, Wiedenmann B, Rosch T. EUS-guided FNA of solid pancreatic masses: high yield of 2 passes with combined histologic-cytologic analysis. Gastrointest Endosc. 2009 Jul;70(1):60-9. doi: 10.1016/j.gie.2008.10.008. Epub 2009 Apr 25.
- Background: PubMed 19032453Sakamoto H, Kitano M, Komaki T, Noda K, Chikugo T, Dote K, Takeyama Y, Das K, Yamao K, Kudo M. Prospective comparative study of the EUS guided 25-gauge FNA needle with the 19-gauge Trucut needle and 22-gauge FNA needle in patients with solid pancreatic masses. J Gastroenterol Hepatol. 2009 Mar;24(3):384-90. doi: 10.1111/j.1440-1746.2008.05636.x. Epub 2008 Nov 20.
- Background: PubMed 28898917Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernandez-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12.
- Background: PubMed 26279842Alatawi A, Beuvon F, Grabar S, Leblanc S, Chaussade S, Terris B, Barret M, Prat F. Comparison of 22G reverse-beveled versus standard needle for endoscopic ultrasound-guided sampling of solid pancreatic lesions. United European Gastroenterol J. 2015 Aug;3(4):343-52. doi: 10.1177/2050640615577533.
- Background: PubMed 25733127Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.
- Background: PubMed 32413915Wang Y, Wang RH, Ding Z, Tan SY, Chen Q, Duan YQ, Zhu LR, Cao JW, Wang J, Shi G, Wu XL, Wang JL, Zhao YC, Tang SJ, Cheng B. Wet- versus dry-suction techniques for endoscopic ultrasound-guided fine-needle aspiration of solid lesions: a multicenter randomized controlled trial. Endoscopy. 2020 Nov;52(11):995-1003. doi: 10.1055/a-1167-2214. Epub 2020 May 15.
- Background: PubMed 32003100Li DF, Wang JY, Yang MF, Xiong F, Zhang DG, Xu ZL, Luo MH, Jing ZD, Wang KX, Wang LS, Yao J. Factors associated with diagnostic accuracy, technical success and adverse events of endoscopic ultrasound-guided fine-needle biopsy: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2020 Aug;35(8):1264-1276. doi: 10.1111/jgh.14999. Epub 2020 Feb 23.
- 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.
DuoWu Zou, Ph.D,M.D study chair
Ruijin hospital Shanghai Jiaotong Universtity, school of medicine
Questions about this trial
What is this clinical trial studying?
A study testing wet suction and standard negative pressure suction in people with Pancreatic Neoplasms and Diagnoses Disease, run by Ruijin Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DuoWu Zou, Ph.D,M.D (+86 13901617608, zdw_pi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic sensitivity of WS technique and SNP technique by EUS-FNB (time frame: 6 month). The study lists 2 primary outcomes in all. 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 NCT04605042, which also lists 11 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 27 Nov 2020.