Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
NCT ID: NCT05252897
Last Updated: 2022-03-09
Study Results
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Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2022-02-01
2026-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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CHAN SHANNON MELISSA
Assistant Professor
Locations
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Royal Adelaide Hospital
Adelaide, , Australia
The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Medanta Institute Of Digestive & Hepatobiliary Sciences
Haryāna, , India
Asian Institute of Gastroenterology
Hyderabad, , India
Deenanath Mangeshkar Hospital & Research Centre
Pune, , India
Asan Medical Centre
Asan, , South Korea
SoonChunHyang University School of Medicine
Asan, , South Korea
Hospital Universitario Rio Hortega
Valladolid, , Spain
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021.465-T
Identifier Type: -
Identifier Source: org_study_id
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