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Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)

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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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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%

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    NA

trial

Study ID

NCT05252897

Intervention or treatment

PROCEDURE: Endoscopic necrosectomy with step up approach

PROCEDURE: Endoscopic necrosectomy with direct approach

Conditions

  • Pancreatic Necrosis

  • Condition: Pancreatic Necrosis

  • PROCEDURE: Endoscopic necrosectomy with step up approach and other drugs

  • Adelaide, Australia

  • Sponsor: Chinese University of Hong Kong

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Research sites nearby

Closest Location:

Royal Adelaide Hospital

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  • Royal Adelaide Hospital

    Adelaide, Australia

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Who is running the clinical trial?

CUoHK

Chinese University of Hong Kong

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
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.
Procedure: Endoscopic necrosectomy with step up approach
    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.
    Procedure: Endoscopic necrosectomy with direct approach

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      A composite of major complications or death within 6 months after randomisationMajor complications include new onset multi-organ failure, multiple organ failure, persistent organ failure, bleeding requiring intervention, perforation of visceral organ requiring intervention, gas embolism6 months

      Secondary Outcome

      MeasureDescriptionTime Frame
      The individual components of the primary endpointThe individual components include new onset multi-organ failure, multiple organ failure, persistent organ failure, bleeding requiring intervention, perforation of visceral organ requiring intervention, gas embolism6 months
      Time to resolution of WOPNLAMS insertion to LAMS removal6 months
      Exocrine pancreatic insufficiencyExocrine 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 pancreatitis6 months
      Biliary stricturesPresence of biliary strictures on cholangiogram/ CT/ MRI6 months
      Total no. of interventionsThe total number of interventions including necrosectomy or other surgical/ radiological interventions6 months
      Length of hospitalThe total length of hospital stay6 months
      Recurrence of WOPNThe recurrence of WOPN detected on imaging (CT/ USG/ MRI/ EUS)6 months
      Unplanned readmissions related to WOPNThe no. of unplanned readmissions related to WOPN6 months
      Endocrine pancreatic insufficiencyInsulin or oral antidiabetic drugs required 6 months after randomization; this requirement was not present before onset of acute pancreatitis6 months
      The no. of necrosectomiesThe number of necrosectomies required6 months
      Total ICU stayNo. of days for ICU stay6 months
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)

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