A prospective, muti-center, randomized, comparative study to evaluate the efficacy and safety of a novel electrocautery-enhanced LAMS (Niti-S HOT SPAXUSTM Stent) versus plastic stent (Compass BDS™ biliary double pigtail plastic stent) used in the endoscopic-guided transmural drainage of walled-off necrosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004087

Enrollment

Registered

2019-06-24

Start date

2019-07-23

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : 1. Device of experimental group Niti-S HOT SPAXUSTM Stent (only used 16mm stent) Made by Taewoong medical, Goyang, Korea 2. Device of control group Compass BDS ™ biliary double pigta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? patients with age =19 years who are needed EUS guided transmural drainage for walled-off necrosis confirmed by CT, MRI, EUS or other diagnostic modality ? at least one of the following criteria - maximal WON size of 6cm or size of less than 6cm with infectious symptom and sign (fever, abdominal pain) requiring drainage procedure on judgement of physicians, - persistant WON at least 4 weeks or more - possible location on EUS for drainage of fluid collection by trans-mural approach, ? the patient accept to participate in the study or provide informed consent

Exclusion criteria

Exclusion criteria: Patients were excluded: 1) if the lesion had only a cystic component without a solid component suspected with pancreatic pseudocyst (pancreatic pseudocyst defined by 2012 Atlanta classification) 2) if the lesion had only a solid component without a cystic component 3) suspected pancreatic cystic tumors or pancreatic malignancies 4) if the coagulation parameters were abnormal (international normalized ratio >1.5 or platelet count <60,000 cells/cmm3) 5) postponing the antithrombotic therapy was impossible 6) if the patient had cardiopulmonary instability 7) pregnancy 8) if the patient had neuro-psychiatric disease such as dementia, seizure 9) Other situations impossible for EUS guided transmural drainage for walled-off necrosis with Niti-S HOT SPAXUSTM Stent or Compass BDS™ plastic stent

Design outcomes

Primary

Measure	Time frame
The total number of procedures needed to achieve clinical success	—

Secondary

Measure	Time frame
Clinical success;Technical success;Stent lumen patency;Stent removal success;Necessity of the direct endoscopic necrosectomy and the number of times, if necessary;Procedure/Device related major adverse events;All other adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactSe Woo Park

Hallym University Medical Center-Dongtan

mdsewoopark@gmail.com+82-31-8086-2858

Outcome results