Pancreatic NecrosisNCT05252897
Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
A study testing Endoscopic necrosectomy with step up approach and Endoscopic necrosectomy with direct approach in people with Pancreatic Necrosis, run by Chinese University of Hong Kong at 9 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Necrosis
- What is being tested?
- Endoscopic necrosectomy with step up approach and Endoscopic necrosectomy with direct approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 1 Feb 2022to 30 Jun 2026
- 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
- Adult (≥18 years of age) patients
- Diagnosis of walled-off pancreatic necrosis (WON) based on imaging criteria based on the revised Atlanta classification5
- Documented history of acute pancreatitis
- 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*
- WON identified at contrast-enhanced computed tomography (CECT) and deemed amenable for EUS-guided drainage
- WON with a solid component >30% and/ or percentage of necrosis >= 30%
Who cannot join
- Previous invasive interventions for necrotising pancreatitis
- An acute flare up of chronic pancreatitis
- Recurrent acute pancreatitis
- Indicated for emergency laparotomy (i.e. abdominal compartment syndrome, perforation of a visceral organ, bleeding and bowel ischaemia)
- Contraindications to endoscopic drainage: previous total gastrectomy, gastric bypass surgery, prior surgery for pancreas-related diseases
- WON not adherent to the GI wall or not accessible for endoscopic drainage
- Coagulopathy (INR >1.5), and/or thrombocytopenia (platelets <50,000/mm3)
- Pregnancy
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
India3 sites, 3 recruiting
- Recruiting
Medanta Institute Of Digestive & Hepatobiliary Sciences
Haryāna
Rajesh Puri, purirajesh1969@gmail.com
- Recruiting
Asian Institute of Gastroenterology
Hyderabad
Sundeep Lakhtakia, drsundeeplakhtakia@gmail.com
- Recruiting
Deenanath Mangeshkar Hospital & Research Centre
Pune
Amol Bapaye, amolbapaye@gmail.com
South Korea2 sites, 2 recruiting
- Recruiting
Asan Medical Centre
Asan
Tae Jun Song, drsong@amc.seoul.kr
- Recruiting
SoonChunHyang University School of Medicine
Asan
Jong Ho Moon, jhmoonsch@gmail.com
Australia1 site, 1 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide
Nam Nguyen, QuocNam.Nguyen@sa.gov.au
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong, 0000
Shannon Chan, 35052627, shannonchan@surgery.cuhk.edu.hk
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Rio Hortega
Valladolid
Manuel Pérez-Miranda, mpmiranda5@hotmail.com
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok
Pradermchai Kongkam, kongkam@hotmail.com
About this study
Official title: Direct Endoscopic Necrosectomy Versus Endoscopic Step-up Approach After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
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.
Read the detailed description
INTRODUCTION Acute pancreatitis is one of the most common gastrointestinal diseases requiring emergency admissions to the hospital. 10-20% of these patients develop pancreatic necrosis and subsequent walled-off pancreatic necrosis (WON) and is associated with a mortality of 20-30%. Grade 1A evidence exists to support an initial minimally invasive drainage approach to infected WON. However, the optimal approach and timing of necrosectomy remains unaddressed. 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.
OBJECTIVE This study aims to investigate the clinical outcomes of the DEN versus the step-up approach for necrosectomy after endoscopic drainage of WON.
HYPOTHESIS The hypothesis is that DEN at the time of LAMS placement improves clinical outcomes after endoscopic drainage of WON as compared to the endoscopic step-up approach.
DESIGN AND SUBJECTS This is a multicentre international randomized controlled trial. Patients with suspected or confirmed infected or symptomatic WON on computed tomography (CT) and who are deemed feasible for endoscopic drainage will be included in the study. Endoscopic drainage with lumen-apposing metal stents (LAMS) will be performed. Patients will be randomised to either the endoscopic step-up approach or direct endoscopic necrosectomy (DEN) approach.
The primary endpoint is a composite of major complications or death within 6 months after randomisation. Secondary endpoints include time to resolution of WON, pancreatic functions, biliary strictures, need for necrosectomy, total number of interventions, length of hospital and ICU stay, recurrence of WON and unplanned readmissions related to WON.
A reduction in cumulative primary endpoint with the DEN approach by 22.4% (32.2% to 9.8%) in comparison to endoscopic step-up approach was assumed. With a 2-sided significance level of 5% and power of 80%, taking into account a 5% drop-out rate, a total of 108 patients was required to demonstrate this effect. Study collaboration has been established with four other international centres. A estimation of 3 years is required to complete study recruitment.
- Conditions
- Pancreatic Necrosis
- Being tested
- Endoscopic necrosectomy with step up approach, Endoscopic necrosectomy with direct approach
- Keywords
- walled off pancreatic necrosis, endoscopic drainage, direct endoscopic necrosectomy, endoscopic step up approach
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic necrosectomy with step up approachProcedure or surgery
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.
Endoscopic necrosectomy with direct approachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic step-up approach | Active comparator | 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. Receives: Procedure: Endoscopic necrosectomy with step up approach |
| Direct endoscopic necrosectomy approach | Active comparator | 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. Receives: Procedure: Endoscopic necrosectomy with direct approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of major complications or death within 6 months after randomisation
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
Measured: 6 months
Secondary outcomes (11)
The individual components of the primary endpoint
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
Measured: 6 months
Time to resolution of WOPN
LAMS insertion to LAMS removal
Measured: 6 months
Exocrine pancreatic insufficiency
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
Measured: 6 months
Biliary strictures
Presence of biliary strictures on cholangiogram/ CT/ MRI
Measured: 6 months
Total no. of interventions
The total number of interventions including necrosectomy or other surgical/ radiological interventions
Measured: 6 months
Length of hospital
The total length of hospital stay
Measured: 6 months
Recurrence of WOPN
The recurrence of WOPN detected on imaging (CT/ USG/ MRI/ EUS)
Measured: 6 months
Unplanned readmissions related to WOPN
The no. of unplanned readmissions related to WOPN
Measured: 6 months
Endocrine pancreatic insufficiency
Insulin or oral antidiabetic drugs required 6 months after randomization; this requirement was not present before onset of acute pancreatitis
Measured: 6 months
The no. of necrosectomies
The number of necrosectomies required
Measured: 6 months
Total ICU stay
No. of days for ICU stay
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Feb 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NecrosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled 2 arm trial
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN SHANNON MELISSA, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252897
- Sponsor's protocol ID
- 2021.465-T
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Endoscopic Necrosectomy Versus Endoscopic Step-up Approach After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
- ClinicalTrials.gov ID
- NCT05252897
- Acronym / sponsor ID
- 2021.465-T
- Conditions
- Pancreatic Necrosis
- Keywords
- walled off pancreatic necrosis, endoscopic drainage, direct endoscopic necrosectomy, endoscopic step up approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Feb 2022 (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.
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.
Detailed description
INTRODUCTION Acute pancreatitis is one of the most common gastrointestinal diseases requiring emergency admissions to the hospital. 10-20% of these patients develop pancreatic necrosis and subsequent walled-off pancreatic necrosis (WON) and is associated with a mortality of 20-30%. Grade 1A evidence exists to support an initial minimally invasive drainage approach to infected WON. However, the optimal approach and timing of necrosectomy remains unaddressed. 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.
OBJECTIVE This study aims to investigate the clinical outcomes of the DEN versus the step-up approach for necrosectomy after endoscopic drainage of WON.
HYPOTHESIS The hypothesis is that DEN at the time of LAMS placement improves clinical outcomes after endoscopic drainage of WON as compared to the endoscopic step-up approach.
DESIGN AND SUBJECTS This is a multicentre international randomized controlled trial. Patients with suspected or confirmed infected or symptomatic WON on computed tomography (CT) and who are deemed feasible for endoscopic drainage will be included in the study. Endoscopic drainage with lumen-apposing metal stents (LAMS) will be performed. Patients will be randomised to either the endoscopic step-up approach or direct endoscopic necrosectomy (DEN) approach.
The primary endpoint is a composite of major complications or death within 6 months after randomisation. Secondary endpoints include time to resolution of WON, pancreatic functions, biliary strictures, need for necrosectomy, total number of interventions, length of hospital and ICU stay, recurrence of WON and unplanned readmissions related to WON.
A reduction in cumulative primary endpoint with the DEN approach by 22.4% (32.2% to 9.8%) in comparison to endoscopic step-up approach was assumed. With a 2-sided significance level of 5% and power of 80%, taking into account a 5% drop-out rate, a total of 108 patients was required to demonstrate this effect. Study collaboration has been established with four other international centres. A estimation of 3 years is required to complete study recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomised controlled 2 arm trial
| Arm | Type | Receives |
|---|---|---|
| Endoscopic step-up approach | Active comparator | Procedure: Endoscopic necrosectomy with step up approachAfter 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. |
| Direct endoscopic necrosectomy approach | Active comparator | Procedure: Endoscopic necrosectomy with direct approachPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (≥18 years of age) patients
- Diagnosis of walled-off pancreatic necrosis (WON) based on imaging criteria based on the revised Atlanta classification5
- Documented history of acute pancreatitis
- 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*
- WON identified at contrast-enhanced computed tomography (CECT) and deemed amenable for EUS-guided drainage
Key exclusion criteria (8 listed)
- Previous invasive interventions for necrotising pancreatitis
- An acute flare up of chronic pancreatitis
- Recurrent acute pancreatitis
- Indicated for emergency laparotomy (i.e. abdominal compartment syndrome, perforation of a visceral organ, bleeding and bowel ischaemia)
- Contraindications to endoscopic drainage: previous total gastrectomy, gastric bypass surgery, prior surgery for pancreas-related diseases
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 necrosectomy with step up approachEndoscopic 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. | Procedure or surgery | Endoscopic step-up approach |
| Endoscopic necrosectomy with direct approachEndoscopic 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. | Procedure or surgery | Direct endoscopic necrosectomy approach |
Primary outcome
A composite of major complications or death within 6 months after randomisation
Time frame: 6 months
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
11 secondary outcomes
The individual components of the primary endpoint
Time frame: 6 months
Time to resolution of WOPN
Time frame: 6 months
Exocrine pancreatic insufficiency
Time frame: 6 months
Biliary strictures
Time frame: 6 months
Total no. of interventions
Time frame: 6 months
Length of hospital
Time frame: 6 months
Recurrence of WOPN
Time frame: 6 months
Unplanned readmissions related to WOPN
Time frame: 6 months
Endocrine pancreatic insufficiency
Time frame: 6 months
The no. of necrosectomies
Time frame: 6 months
Total ICU stay
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- 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.
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic necrosectomy with step up approach and Endoscopic necrosectomy with direct approach in people with Pancreatic Necrosis, run by Chinese University of Hong Kong at 9 sites in 6 countries.
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 6 inclusion and 8 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India, South Korea, Australia, Hong Kong, Spain and 1 more country. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannon Chan (852-35052627, shannonchan@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of major complications or death within 6 months after randomisation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2022.