Trial Review

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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)
Scientific title
Direct Endoscopic Necrosectomy Versus Endoscopic Step-up Approach After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
Secondary ID [1] 0 0
2021.465-T
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Necrosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
A composite of major complications or death within 6 months after randomisation
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
The individual components of the primary endpoint
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Time to resolution of WOPN
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Exocrine pancreatic insufficiency
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Biliary strictures
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Total no. of interventions
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Length of hospital
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Recurrence of WOPN
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Unplanned readmissions related to WOPN
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
Endocrine pancreatic insufficiency
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
The no. of necrosectomies
Timepoint [10] 0 0
6 months
Secondary outcome [11] 0 0
Total ICU stay
Timepoint [11] 0 0
6 months

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%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
India
State/province [2] 0 0
Haryana
Country [3] 0 0
India
State/province [3] 0 0
Hyderabad
Country [4] 0 0
India
State/province [4] 0 0
Pune
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Asan
Country [6] 0 0
Spain
State/province [6] 0 0
Valladolid
Country [7] 0 0
Thailand
State/province [7] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Other
Name
Chinese University of Hong Kong
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05252897
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shannon Chan
Address 0 0
Country 0 0
Phone 0 0
852-35052627
Fax 0 0
Email 0 0
shannonchan@surgery.cuhk.edu.hk
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05252897