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

NCT04479228 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-07-21

No results posted yet for this study

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

Interventions

DEVICE

Endosonography guided transmural drainage

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

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-08-01
Completion
2022-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04479228 on ClinicalTrials.gov