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

NCT05252897 | Recruiting DMC

• 1 other identifier: 2021.465-T
• Study Type: interventional
• Target: 108
• Locations: 6 countries
• Sites: 9

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.

Conditions

Pancreatic Necrosis

Keywords

walled off pancreatic necrosis; endoscopic drainage; direct endoscopic necrosectomy; endoscopic step up approach

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (11)

• The individual components of the primary endpoint

  6 months

• Time to resolution of WOPN

  6 months

• Exocrine pancreatic insufficiency

  6 months

• Biliary strictures

  6 months

• Total no. of interventions

  6 months

Study Arms (2)

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.

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.

Procedure: Endoscopic necrosectomy with direct approach

Interventions

Endoscopic necrosectomy with step up approach PROCEDURE

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 step-up approach

Endoscopic necrosectomy with direct approach PROCEDURE

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.

Direct endoscopic necrosectomy approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (9)

Royal Adelaide Hospital

Adelaide, Australia

RECRUITING

The Chinese University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

Medanta Institute Of Digestive & Hepatobiliary Sciences

Haryāna, India

RECRUITING

Asian Institute of Gastroenterology

Hyderabad, India

RECRUITING

Deenanath Mangeshkar Hospital & Research Centre

Pune, India

RECRUITING

Asan Medical Centre

Asan, South Korea

RECRUITING

SoonChunHyang University School of Medicine

Asan, South Korea

RECRUITING

Hospital Universitario Rio Hortega

Valladolid, Spain

RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Shannon Chan

CONTACT

852-35052627; shannonchan@surgery.cuhk.edu.hk

Anthony Teoh

CONTACT

852-35052627; anthonyteoh@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomised controlled 2 arm trial

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 23, 2022
• Study Start: February 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3); KR (2); ES (1); HK (1); TH (1); AU (1)