Direct Endoscopic Necrosectomy Versus Endoscopic Step-up Approach After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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%

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Hong Kong Special Administrative Region
The Chinese University of Hong Kong
RECRUITING
Hong Kong
India
Medanta Institute Of Digestive & Hepatobiliary Sciences
RECRUITING
Haryāna
Asian Institute of Gastroenterology
RECRUITING
Hyderabad
Deenanath Mangeshkar Hospital & Research Centre
RECRUITING
Pune
Republic of Korea
Asan Medical Centre
RECRUITING
Asan
SoonChunHyang University School of Medicine
RECRUITING
Asan
Spain
Hospital Universitario Rio Hortega
RECRUITING
Valladolid
Thailand
King Chulalongkorn Memorial Hospital
RECRUITING
Bangkok
Contact Information
Primary
Shannon Chan
shannonchan@surgery.cuhk.edu.hk
852-35052627
Backup
Anthony Teoh
anthonyteoh@surgery.cuhk.edu.hk
852-35052627
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 108
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov