NCT03923686

Brief Summary

A prospective randomized cohort study to compare whether the placement of a double-pigtail plastic stent (DPS) within a lumen-apposing metal stent (LAMS) may improve the efficacy and safety of endoscopic ultrasound guided transmural drainage of walled-off pancreatic necrosis (WON) and thus prevent potential adverse events related to LAMS insertion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

May 13, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

2.6 years

First QC Date

April 12, 2019

Last Update Submit

April 1, 2023

Conditions

Pancreatitis, Acute NecrotizingWalled Off Necrosis

Keywords

Walled off necrosisAcute pancreatitisNecrotizing pancreatitisEndoscopic drainageLumen apposing metal stentsDouble pigtail plastic stent

Outcome Measures

Primary Outcomes (2)

  • Failure of method

    Defined as a necessity of re-intervention (endoscopic, surgical, percutaneous) within the period following LAMS insertion and before its planned extraction due to complications related to LAMS insertion and/or clinical deterioration.

    up to 1 month

  • Mortality

    Overall mortality during subsequent follow-up

    up to 12 months

Secondary Outcomes (6)

  • Clinical success rate

    up to 1 month

  • Adverse events

    up to 1 month

  • Number of procedures

    up to 1 month

  • Hospital stay

    up to 1 month

  • Recurrence rate

    up to 12 months

  • +1 more secondary outcomes

Study Arms (2)

LAMS plus DPS

EXPERIMENTAL

Endoscopic ultrasound-guided (EUS) transmural drainage of walled-off pancreatic necrosis (WON) using lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPS).

Procedure: EUS-guided drainage using LAMS with DPS

LAMS alone

ACTIVE COMPARATOR

Endoscopic ultrasound-guided (EUS) transmural drainage of walled-off pancreatic necrosis (WON) using lumen-apposing metal stent (LAMS) alone.

Procedure: EUS-guided drainage using LAMS alone

Interventions

EUS-guided drainage using LAMS with DPSPROCEDURE

Endoscopic ultrasound-guided drainage using lumen-apposing metal stent with coaxial plastic stent in the treatment of walled-off pancreatic necrosis.

LAMS plus DPS
EUS-guided drainage using LAMS alonePROCEDURE

Endoscopic ultrasound-guided drainage using lumen-apposing metal stent without coaxial plastic stent in the treatment of walled-off pancreatic necrosis.

LAMS alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • walled-off pancreatic necrosis (WON) indicated for endoscopical drainage
  • signed informed consent form

You may not qualify if:

  • patient disagreement with the study
  • types of collections other than WON
  • drainage with stents other than LAMS
  • previous attempts at drainage of WON
  • severe coagulopathy or thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Olomouc, Second Department of Internal Medicine - Gastroenterology and Geriatrics

Olomouc, 77900, Czechia

Location

Related Publications (1)

  • Vanek P, Falt P, Vitek P, Zoundjiekpon V, Horinkova M, Zapletalova J, Lovecek M, Urban O. EUS-guided transluminal drainage using lumen-apposing metal stents with or without coaxial plastic stents for treatment of walled-off necrotizing pancreatitis: a prospective bicentric randomized controlled trial. Gastrointest Endosc. 2023 Jun;97(6):1070-1080. doi: 10.1016/j.gie.2022.12.026. Epub 2023 Jan 13.

    PMID: 36646148DERIVED

MeSH Terms

Conditions

Pancreatitis, Acute NecrotizingPancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Petr Vanek, MD

    Assistant Professor, physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a prospective randomized cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 22, 2019

Study Start

May 13, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

April 4, 2023

Record last verified: 2023-04

Locations

CZ(1)