Malignant Biliary ObstructionNCT06375954
EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)
A study testing Endoscopic biliary drainage, Self-expandable metallic stent (SEMS) and Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) in people with Malignant Biliary Obstruction and Pancreatic Cancer, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction, Pancreatic Cancer, Biliary Tract Neoplasms
- What is being tested?
- Endoscopic biliary drainage, Self-expandable metallic stent (SEMS) and Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Malignant distal biliary obstruction diagnosed in patient considered BORDERLINE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.
- Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)
- Patient capable of understanding and/or singning the informed consent.
- Patient who understands the type of study and will comply with all follow-up tests throughout its duration
Who cannot join
- Pregnancy or lactation.
- Severe coagulation disorder: INR > 1.5 non correctable with plasma administration and/or platelet count < 50.000/mm3.
- Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative
- Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.
- Patients with prior biliary stents or other biliary drainages (e.g., PTCD).
- Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y).
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- Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla.
- Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture).
- Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available.
- Patients incapable of maintaining follow-up appointments (lack of adherence).
- Lack of informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Joan B Gornals, MD, PhD, + 34 93 260 7682 ext. 2624, jgornals@bellvitgehospital.cat
Maria Puigcerver-Mas, MD, +34 687332007, mariapuigcervermas@gmail.com
About this study
Official title: Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction in Borderline Disease: An Open-label, Multicenter Randomized Trial (CARPEDIEM-2 Trial)
The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.
Read the detailed description
Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). However, there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients, showing similar clinical and technical success and adverse events (AEs) rate between both techniques. Data about the benefit of this techique in borderline patients is still limited.
A recent retrospective study (Janet J et al, Ann Surg Oncol 2023) which included borderline patients, found that EUS-CDS group had significantly less delay (days) between biliary drainage and neoadjuvant chemotherapy start than the ERCP group with fewer endoscopy and surgery AEs.
Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between biliary drainage and neoadjuvant chemotherapy start when compared to ERCP in MDBO in borderline patients.
- Being tested
- Endoscopic biliary drainage, Self-expandable metallic stent (SEMS), Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
- Keywords
- Choledochoduodenostomy, Therapeutic endoscopy, Biliary Drainage, Lumen apposing metal stent, ERCP, Biliopancreatic malignancy
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic biliary drainageProcedure or surgery
Also called Biliary drainage
Decompression of the bile duct by endoscopic aproach.
Self-expandable metallic stent (SEMS)Device
Self-expandable metallic stent (SEMS) deployment:
- Covering: Uncovered or Partially Covered. Non covered if gallbladder is present.
- Size: 10x40mm or 10x60mm or 10x80mm.
Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)Device
Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment:
- LAMS size: 6x8mm or 8x8mm. Consider 10x10mm if bile duct > 18mm.
- DPPS size: 7Fr x 3-7cm.
| Study group | Role | What they receive |
|---|---|---|
| ERCP with SEMS | Active comparator | Endoscopic retrograde cholangiopancreatography (ERCP) with deployment of a self-expandable metallic stent (SEMS). Gold standard in malignant distal biliary obstruction (MDBO) in current practice.
ERCP technique: Cannulation with papillotome (advanced cannulation techniques are allowed). Sphincterotomy. Self-expandable metallic stent (SEMS) deployment. Receives: Procedure: Endoscopic biliary drainage; Device: Self-expandable metallic stent (SEMS) |
| EUS-CDS with LAMS-Pigtail | Experimental | Echoendoscopy-guided Choledochoduodenostomy (EUS-CDS) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS.
EUS-CDS technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire choledochoduodenostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. In case of bile duct < 15mm is mandatory the 'push' technique. Deployment of a pigtail coaxial to LAMS. Receives: Procedure: Endoscopic biliary drainage; Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in days between endoscopic biliary drainage and chemotherapy treatment start
Number of days between intervention (T1-biliary drainage) and chemotherapy treatment start.
Measured: 1 day to 12 months
Secondary outcomes (5)
Technical success
ERCP group: cannulation, cholangiogram, correct deployment of SEMS
Measured: day 0
Clinical success
In jaundice: decreasing > 50% of bilirrubin or normalization of bilirrubin levels 14 days after endoscopic procedure.
Measured: 14 days after BD
AE - biliary drainage
Adverse events rate related to biliary drainage according to the AGREE classification
Measured: 0 to 30 days after BD
AE - surgery
Adverse events rate related to surgery according to the Claiven and Dindo classification.
Measured: 0 to 90 days after surgery
Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP)
Number of days between intervention (T1-biliary drainage) and surgery
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Malignant Biliary ObstructionStudies 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Hospital Clínico Universitario de Valencia, Hospital General Universitario de Alicante, Hospital Universitario Ramon y Cajal, Hospital General Universitario de Castellón, Hospital Álvaro Cunqueiro, Complejo Hospitalario Universitario de Santiago, University Hospital Virgen de las Nieves, Complejo Hospitalario de Navarra, Hospital de Sant Pau, University of Salamanca
- Responsible party
- Principal investigator, Joan B Gornals, Hospital Universitari de Bellvitge
- Investigators
- Joan B Gornals, PhD, Principal investigator, Hospital Universitari de Bellvitge, SEED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375954
- Sponsor's protocol ID
- CARPEDIEM-2
- Status last verified
- Sep 2023
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Teoh AYB, Napoleon B, Kunda R, Arcidiacono PG, Kongkam P, Larghi A, Van der Merwe S, Jacques J, Legros R, Thawee RE, Saxena P, Aerts M, Archibugi L, Chan SM, Fumex F, Kaffes AJ, Ma MTW, Messaoudi N, Rizzatti G, Ng KKC, Ng EKW, Chiu PWY. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023 Aug;165(2):473-482.e2. doi: 10.1053/j.gastro.2023.04.016. Epub 2023 Apr 28.
PubMed 37121331Janet J, Albouys J, Napoleon B, Jacques J, Mathonnet M, Magne J, Fontaine M, de Ponthaud C, Durand Fontanier S, Bardet SSM, Bourdariat R, Sulpice L, Lesurtel M, Legros R, Truant S, Robin F, Prat F, Palazzo M, Schwarz L, Buc E, Sauvanet A, Gaujoux S, Taibi A. Pancreatoduodenectomy Following Preoperative Biliary Drainage Using Endoscopic Ultrasound-Guided Choledochoduodenostomy Versus a Transpapillary Stent: A Multicenter Comparative Cohort Study of the ACHBT-FRENCH-SFED Intergroup. Ann Surg Oncol. 2023 Aug;30(8):5036-5046. doi: 10.1245/s10434-023-13466-8. Epub 2023 Apr 17.
PubMed 37069476Paik WH, Lee TH, Park DH, Choi JH, Kim SO, Jang S, Kim DU, Shim JH, Song TJ, Lee SS, Seo DW, Lee SK, Kim MH. EUS-Guided Biliary Drainage Versus ERCP for the Primary Palliation of Malignant Biliary Obstruction: A Multicenter Randomized Clinical Trial. Am J Gastroenterol. 2018 Jul;113(7):987-997. doi: 10.1038/s41395-018-0122-8. Epub 2018 Jul 2.
PubMed 29961772Bang JY, Hawes R, Varadarajulu S. Endoscopic biliary drainage for malignant distal biliary obstruction: Which is better - endoscopic retrograde cholangiopancreatography or endoscopic ultrasound? Dig Endosc. 2022 Jan;34(2):317-324. doi: 10.1111/den.14186. Epub 2021 Nov 29.
PubMed 34748675
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction in Borderline Disease: An Open-label, Multicenter Randomized Trial (CARPEDIEM-2 Trial)
- ClinicalTrials.gov ID
- NCT06375954
- Acronym / sponsor ID
- CARPEDIEM-2
- Keywords
- Choledochoduodenostomy, Therapeutic endoscopy, Biliary Drainage, Lumen apposing metal stent, ERCP, Biliopancreatic malignancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Hospital Clínico Universitario de Valencia, Hospital General Universitario de Alicante, Hospital Universitario Ramon y Cajal, Hospital General Universitario de Castellón, Hospital Álvaro Cunqueiro, Complejo Hospitalario Universitario de Santiago, University Hospital Virgen de las Nieves, Complejo Hospitalario de Navarra, Hospital de Sant Pau, University of Salamanca
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 Apr 2024 (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 aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.
Detailed description
Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). However, there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients, showing similar clinical and technical success and adverse events (AEs) rate between both techniques. Data about the benefit of this techique in borderline patients is still limited.
A recent retrospective study (Janet J et al, Ann Surg Oncol 2023) which included borderline patients, found that EUS-CDS group had significantly less delay (days) between biliary drainage and neoadjuvant chemotherapy start than the ERCP group with fewer endoscopy and surgery AEs.
Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between biliary drainage and neoadjuvant chemotherapy start when compared to ERCP in MDBO in borderline patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP with SEMS | Active comparator | Procedure: Endoscopic biliary drainage, Device: Self-expandable metallic stent (SEMS)Endoscopic retrograde cholangiopancreatography (ERCP) with deployment of a self-expandable metallic stent (SEMS). Gold standard in malignant distal biliary obstruction (MDBO) in current practice. ERCP technique: Cannulation with papillotome (advanced cannulation techniques are allowed). Sphincterotomy. Self-expandable metallic stent (SEMS) deployment. |
| EUS-CDS with LAMS-Pigtail | Experimental | Procedure: Endoscopic biliary drainage, Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)Echoendoscopy-guided Choledochoduodenostomy (EUS-CDS) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS. EUS-CDS technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire choledochoduodenostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. In case of bile duct < 15mm is mandatory the 'push' technique. Deployment of a pigtail coaxial to LAMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Malignant distal biliary obstruction diagnosed in patient considered BORDERLINE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.
- Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)
- Patient capable of understanding and/or singning the informed consent.
- Patient who understands the type of study and will comply with all follow-up tests throughout its duration
Key exclusion criteria (11 listed)
- Pregnancy or lactation.
- Severe coagulation disorder: INR > 1.5 non correctable with plasma administration and/or platelet count < 50.000/mm3.
- Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative
- Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.
- Patients with prior biliary stents or other biliary drainages (e.g., PTCD).
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 |
|---|---|---|
| Endoscopic biliary drainageAlso: Biliary drainageDecompression of the bile duct by endoscopic aproach. | Procedure or surgery | ERCP with SEMS, EUS-CDS with LAMS-Pigtail |
| Self-expandable metallic stent (SEMS)Self-expandable metallic stent (SEMS) deployment: * Covering: Uncovered or Partially Covered. Non covered if gallbladder is present. * Size: 10x40mm or 10x60mm or 10x80mm. | Device | ERCP with SEMS |
| Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment: * LAMS size: 6x8mm or 8x8mm. Consider 10x10mm if bile duct > 18mm. * DPPS size: 7Fr x 3-7cm. | Device | EUS-CDS with LAMS-Pigtail |
Primary outcome
Delay in days between endoscopic biliary drainage and chemotherapy treatment start
Time frame: 1 day to 12 months
Number of days between intervention (T1-biliary drainage) and chemotherapy treatment start.
5 secondary outcomes
Technical success
Time frame: day 0
Clinical success
Time frame: 14 days after BD
AE - biliary drainage
Time frame: 0 to 30 days after BD
AE - surgery
Time frame: 0 to 90 days after surgery
Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP)
Time frame: 6 to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Results publication: PubMed 37121331Teoh AYB, Napoleon B, Kunda R, Arcidiacono PG, Kongkam P, Larghi A, Van der Merwe S, Jacques J, Legros R, Thawee RE, Saxena P, Aerts M, Archibugi L, Chan SM, Fumex F, Kaffes AJ, Ma MTW, Messaoudi N, Rizzatti G, Ng KKC, Ng EKW, Chiu PWY. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023 Aug;165(2):473-482.e2. doi: 10.1053/j.gastro.2023.04.016. Epub 2023 Apr 28.
- Results publication: PubMed 37069476Janet J, Albouys J, Napoleon B, Jacques J, Mathonnet M, Magne J, Fontaine M, de Ponthaud C, Durand Fontanier S, Bardet SSM, Bourdariat R, Sulpice L, Lesurtel M, Legros R, Truant S, Robin F, Prat F, Palazzo M, Schwarz L, Buc E, Sauvanet A, Gaujoux S, Taibi A. Pancreatoduodenectomy Following Preoperative Biliary Drainage Using Endoscopic Ultrasound-Guided Choledochoduodenostomy Versus a Transpapillary Stent: A Multicenter Comparative Cohort Study of the ACHBT-FRENCH-SFED Intergroup. Ann Surg Oncol. 2023 Aug;30(8):5036-5046. doi: 10.1245/s10434-023-13466-8. Epub 2023 Apr 17.
- Results publication: PubMed 29961772Paik WH, Lee TH, Park DH, Choi JH, Kim SO, Jang S, Kim DU, Shim JH, Song TJ, Lee SS, Seo DW, Lee SK, Kim MH. EUS-Guided Biliary Drainage Versus ERCP for the Primary Palliation of Malignant Biliary Obstruction: A Multicenter Randomized Clinical Trial. Am J Gastroenterol. 2018 Jul;113(7):987-997. doi: 10.1038/s41395-018-0122-8. Epub 2018 Jul 2.
- Results publication: PubMed 34748675Bang JY, Hawes R, Varadarajulu S. Endoscopic biliary drainage for malignant distal biliary obstruction: Which is better - endoscopic retrograde cholangiopancreatography or endoscopic ultrasound? Dig Endosc. 2022 Jan;34(2):317-324. doi: 10.1111/den.14186. Epub 2021 Nov 29.
- 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.
Joan B Gornals, PhD principal investigator
Hospital Universitari de Bellvitge, SEED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic biliary drainage, Self-expandable metallic stent (SEMS) and Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) in people with Malignant Biliary Obstruction and Pancreatic Cancer, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 19 Apr 2024. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Puigcerver-Mas, MD, (+34 687332007, mariapuigcervermas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay in days between endoscopic biliary drainage and chemotherapy treatment start (time frame: 1 day to 12 months). 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 NCT06375954, which also lists 4 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 19 Apr 2024.