NCT03649399

Brief Summary

The Retention of pancreatic stents for prophylaxis of post-ERCP pancreatitis (PEP) is assessed by abdominal x-ray according to international Guidelines. The current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration 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

Study Start

First participant enrolled

March 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2.1 years

First QC Date

August 25, 2018

Last Update Submit

April 21, 2020

Conditions

PancreatitisStent Dislodgement

Outcome Measures

Primary Outcomes (1)

  • Positive predictive value of the sonographic detection of pancreatic stents

    Test whether the stents can be detected reliably by ultrasound

    5-10 days after stent placement

Secondary Outcomes (1)

  • Negative predictive value of the sonographic detection of pancreatic stents

    5-10 days after stent placement

Study Arms (1)

Patients with pancreatic stent

EXPERIMENTAL

abdominal ultrasound and x-ray for stent detection.

Diagnostic Test: Abdominal ultrasound

Interventions

Abdominal ultrasoundDIAGNOSTIC_TEST

Abdominal ultrasound for detection of the pancreatic stent

Patients with pancreatic stent

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient after pancreatic stent placement for prophylaxis of post-ERCP pancreatitis
  • age 18-79
  • signed informed consent

You may not qualify if:

  • any disease that rules out study participation
  • patient not legally competent to sign informed consent
  • chronic pancreatis as indication for pancreatic stenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der J.W. Goethe-Universität

Frankfurt am Main, Germany

Location

Related Publications (1)

  • Michael FA, Gerber L, Weiler N, Hunyady PM, Abedin N, de la Vera AL, Stoffers P, Filmann N, Zeuzem S, Bojunga J, Friedrich-Rust M, Dultz G. Transabdominal ultrasonography to reduce the burden of X-ray imaging in prophylactic pancreatic stent localization after ERCP-A prospective trial. United European Gastroenterol J. 2021 May;9(4):469-477. doi: 10.1002/ueg2.12063. Epub 2021 Apr 22.

    PMID: 33887119DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Mireen Friedrich-Rust, MD

    Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 25, 2018

First Posted

August 28, 2018

Study Start

March 1, 2018

Primary Completion

April 21, 2020

Study Completion

April 21, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)