Plastic Stents vs. NAGI Bi-flanged Metal Stent for Endoscopic Ultrasound Guided Drainage of Walled-off Necrosis

NCT04479228 | Unknown DMC

• 1 other identifier: WON_NAGIvsPlastic
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Walled off necrosis (WON) is defined as a well circumscribed pancreatic and/or peri pancreatic necrosis containing a variable amount of necrotic tissue. WON usually occurs \>4 weeks after onset of necrotizing pancreatitis. It is associated with significant morbidity and mortality especially if infected. Symptomatic WON should be drained either percutaneously, endoscopically or surgically. Minimal invasive approaches are being increasingly used for effective management of WON as it is associated with less adverse events. Various recent studies have shown that endoscopic approach have improved clinical outcome, less hospital stay and lower cost compared to surgical approach. Endoscopic ultrasound guided drainage of WON with either plastic stents or lumen apposing metal stents (LAMS) is mainstay of WON management. A systemic review based on retrospective comparative studies showed no difference regarding treatment success for WON by plastic or metal stents6. However, metal stent had shorter procedure time. A Single center RCT from USA comparing LAMS vs multiple plastic stents for WON has shown that except shorter procedure duration, there was no significant difference in treatment outcomes. To minimize LAMS related adverse events, it should be removed within 3 weeks. However, in the same study 25.8% patients of LAMS group and 55.2% patients of plastic stent group underwent additional intervention within 72 hours for persistent symptoms. Larger diameter, specific stent designs to reduce adverse events should have better outcome with LAMS as compared to plastic stents. Primary outcome of this single center randomized controlled trial is to examine whether dedicated NAGI bi-flanged metal stents (BFMS) are superior to plastic stent in terms of short term and long term success. Aims and Hypothesis: The aim of the current study is to study whether NAGI BFMS are superior to plastic stent in terms of short term and long term success in the EUS guided drainage of WON. The investigators hypothesize that the clinical success with NAGI BFMS would be better than plastic stents in the EUS guided drainage of WON.

Conditions

Acute Necrotizing Pancreatitis; Walled Off Necrosis

Outcome Measures

Primary Outcomes (1)

• Number of patient achieving Clinical Success

  Clinical success at 4 weeks determined by the reduction of the collection (\<50% or \<5 cm in size) along with resolution of symptoms.

  4 weeks

Secondary Outcomes (3)

• Re-Interventions

  4 weeks

• Number of patients achieving Long term success

  24 weeks

• Number of patients developing Adverse events

  24 weeks

Study Arms (2)

NAGI bi-flanged metal stent (BFMS)

EXPERIMENTAL

The WON will be punctured using a standard 19-gauge FNA needle and the aspirate was sent for biochemical and microbial analysis. A 0.025-inch (Visiglide; Olympus Corporation, Tokyo, Japan) or 0.035-inch stiff guidewire (Jag Wire; Boston Scientific) passed through the needle into the cyst cavity to form at least 1 to 2 loops under fluoroscopic guidance. A 6F cystotome (Endo-flex GmbH Dusseldorf, Germany) will be passed over the guidewire for creating a fistula. Subsequently, a 6-mm balloon dilator (Hurricane; Boston Scientific Corporation or Titan balloon, Wilson Cook) will be used to further dilate the fistula tract. After this, the stent delivery catheter is advanced over the guidewire across the PFC wall and the BFMS (Nagi; Taewoong Medical, Gyeonggi-do, South Korea) deployed using sonographic, fluoroscopic and endoscopic visualization.

Device: Endosonography guided transmural drainage

Plastic stents

EXPERIMENTAL

Double-pigtail plastic stents will be used. A minimum of one 10Fr pigtail plastic stent will be placed. After initial EUS-guided access, the ostomy will be dilated first, using a cystotome, and secondly with a balloon dilation. The plastic stent will be inserted and delivered following the routine technique of each interventional endoscopist. The number of the plastic stents and the size of the balloon used to dilate the ostomy will depend on the WON size and content.

Device: Endosonography guided transmural drainage

Interventions

Endosonography guided transmural drainage DEVICE

The procedures would be performed by experienced endoscopists. All procedures will be performed with the patient in the left lateral position under propofol sedation after administration of intravenous antibiotics (third generation cephalosporins) A therapeutic linear echo-endoscope (UCT-180; Olympus Ltd, Tokyo, Japan) will be used; the PFC assessed for size, wall maturity, thickness, interposing collaterals and percentage of solid debris

NAGI bi-flanged metal stent (BFMS); Plastic stents

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,
• Patient with symptomatic WON
• Debris \<50% (based on cross sectional imaging)
• Written informed consent

You may not qualify if:

• Pregnancy or breast feeding,
• Severe coagulopathy INR \>1.5 which is not correctable and/or platelets \<50000/mm3
• Endoscopic drainage is technically not feasible
• Fluid collections other than WON
• Patient who is unable to understand study protocol or not willing for follow-up requirements

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Nitin Jagtap, MD

CONTACT

04023378888; docnits13@gmail.com

Krithikrishna Koduri, MD

CONTACT

04023378888; krithivk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 21, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: January 1, 2022
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share