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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05252897
Registration number
NCT05252897
Ethics application status
Date submitted
14/02/2022
Date registered
23/02/2022
Date last updated
9/03/2022
Titles & IDs
Public title
Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
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Scientific title
Direct Endoscopic Necrosectomy Versus Endoscopic Step-up Approach After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
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Secondary ID [1]
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2021.465-T
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatic Necrosis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic necrosectomy with step up approach
Treatment: Surgery - Endoscopic necrosectomy with direct approach
Active Comparator: Endoscopic step-up approach - After endoscopic drainage of WON, patients will be reassessed 72 hours after the procedure. If there is no clinical improvement 72 hours after drain placement, a CECT is performed to check the adequacy of the drainage. Irrigation of the WON via a nasocystic drain or endoscopic irrigation (step 1) is performed in case of inadequate drainage. If a nasocystic drain is inserted, 500ml of normal saline, twice a day will be used to irrigate the WON. If endoscopic irrigation is performed, only irrigation with normal saline without necrosectomy is allowed.
Patients are again evaluated 72 hours after step 1. In case of improvement, treatment is conservative; otherwise step 2 will be initiated, which is endoscopic necrosectomy. Further endoscopic necrosectomy will be performed until there is clinical improvement.
Active Comparator: Direct endoscopic necrosectomy approach - Patients in the DEN group will undergo an immediate endoscopic necrosectomy after LAMS placement and balloon dilatation. A 10Fr 5cm double pigtail plastic stent will be inserted within the LAMS after necrosectomy. Patients will be assessed in 72 hours after the procedure. If there is no clinical improvement, a CECT is performed to check the adequacy of the drainage. DEN will be repeated in case of inadequate drainage. Patients will be reassessed every 72 hours and DEN repeated until there is clinical improvement. Subsequently, necrosectomy is performed weekly until a reassessment CECT at 3 weeks.
Treatment: Surgery: Endoscopic necrosectomy with step up approach
Endoscopic necrosectomy will be performed with a forward-viewing gastroscope into the WON cavity. Debridement of necrotic tissue will be performed with irrigation and/or mechanical removal with endoscopic instruments. For this arm, step up approach will be adopted.
Treatment: Surgery: Endoscopic necrosectomy with direct approach
Endoscopic necrosectomy will be performed with a forward-viewing gastroscope into the WON cavity. Debridement of necrotic tissue will be performed with irrigation and/or mechanical removal with endoscopic instruments. For this arm, the direct approach will be adopted.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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A composite of major complications or death within 6 months after randomisation
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Assessment method [1]
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Major complications include new onset multi-organ failure, multiple organ failure, persistent organ failure, bleeding requiring intervention, perforation of visceral organ requiring intervention, gas embolism
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Timepoint [1]
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6 months
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Secondary outcome [1]
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The individual components of the primary endpoint
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Assessment method [1]
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The individual components include new onset multi-organ failure, multiple organ failure, persistent organ failure, bleeding requiring intervention, perforation of visceral organ requiring intervention, gas embolism
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Time to resolution of WOPN
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Assessment method [2]
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LAMS insertion to LAMS removal
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Exocrine pancreatic insufficiency
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Assessment method [3]
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Exocrine pancreatic insufficiency defined as Oral pancreatic-enzyme supplementation required to treat clinical symptoms of steatorrhea 6 months after randomization; this requirement was not present before onset of acute pancreatitis
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Biliary strictures
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Assessment method [4]
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Presence of biliary strictures on cholangiogram/ CT/ MRI
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Timepoint [4]
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6 months
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Secondary outcome [5]
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Total no. of interventions
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Assessment method [5]
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The total number of interventions including necrosectomy or other surgical/ radiological interventions
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Length of hospital
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Assessment method [6]
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The total length of hospital stay
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Timepoint [6]
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6 months
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Secondary outcome [7]
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Recurrence of WOPN
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Assessment method [7]
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The recurrence of WOPN detected on imaging (CT/ USG/ MRI/ EUS)
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Timepoint [7]
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6 months
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Secondary outcome [8]
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Unplanned readmissions related to WOPN
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Assessment method [8]
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The no. of unplanned readmissions related to WOPN
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Timepoint [8]
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6 months
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Secondary outcome [9]
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Endocrine pancreatic insufficiency
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Assessment method [9]
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Insulin or oral antidiabetic drugs required 6 months after randomization; this requirement was not present before onset of acute pancreatitis
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Timepoint [9]
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6 months
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Secondary outcome [10]
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The no. of necrosectomies
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Assessment method [10]
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The number of necrosectomies required
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Timepoint [10]
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6 months
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Secondary outcome [11]
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Total ICU stay
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Assessment method [11]
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No. of days for ICU stay
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Timepoint [11]
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6 months
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Eligibility
Key inclusion criteria
1. Adult (=18 years of age) patients
2. Diagnosis of walled-off pancreatic necrosis (WON) based on imaging criteria based on
the revised Atlanta classification5
3. Documented history of acute pancreatitis
4. Suspected or confirmed infected WON and/or symptomatic WON causing (i) persistent
pancreatic-type pain, and/or ii) gastric outlet or biliary obstruction, and/or (iii)
ongoing systemic illness, anorexia, and weight loss, and/or (iv) rapidly enlarging
WONs, and/or (v) infected WON*
5. WON identified at contrast-enhanced computed tomography (CECT) and deemed amenable for
EUS-guided drainage
6. WON with a solid component >30% and/ or percentage of necrosis >= 30%
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Previous invasive interventions for necrotising pancreatitis
2. An acute flare up of chronic pancreatitis
3. Recurrent acute pancreatitis
4. Indicated for emergency laparotomy (i.e. abdominal compartment syndrome, perforation
of a visceral organ, bleeding and bowel ischaemia)
5. Contraindications to endoscopic drainage: previous total gastrectomy, gastric bypass
surgery, prior surgery for pancreas-related diseases
6. WON not adherent to the GI wall or not accessible for endoscopic drainage
7. Coagulopathy (INR >1.5), and/or thrombocytopenia (platelets <50,000/mm3)
8. Pregnancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
108
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Hong Kong
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Country [2]
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India
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State/province [2]
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Haryana
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Country [3]
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India
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State/province [3]
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Hyderabad
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Country [4]
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India
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State/province [4]
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Pune
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Country [5]
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Korea, Republic of
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State/province [5]
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Asan
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Country [6]
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Spain
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State/province [6]
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Valladolid
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Country [7]
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Thailand
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State/province [7]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Other
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Name
Chinese University of Hong Kong
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Walled-off pancreatic necrosis (WON) is associated with a mortality of 20-30%. The current
evidence supports a minimally invasive drainage approach to infected WON. The current
suggested approach in international guidelines is the endoscopic step-up approach. However,
recent evidence from large national cohorts support the use of direct endoscopic necrosectomy
(DEN) at the time of stent placement, resulting in earlier resolution of WON and less number
of necrosectomies. This study aims to investigate the clinical outcomes of the DEN versus the
step-up approach for necrosectomy after endoscopic drainage of WON.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05252897
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Shannon Chan
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Address
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Country
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Phone
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852-35052627
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05252897
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