Sonographic Detection of Prophylactic Pancreatic Stents

NCT ID: NCT03649399

Last Updated: 2020-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-04-21

Brief Summary

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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.

Detailed Description

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Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Several pharmacologic and procedure-related measurements have been established for post-ERCP pancreatitis (PEP) prophylaxis one being the placement of pancreatic duct stents in patients with high risk for PEP. The beneficial role of pancreatic stenting in the prophylaxis of PEP was demonstrated in large meta-analyses. The used stents have a high potential of self dislodgment, retained stents have to be removed endoscopically after 5-10 days. For evaluation of spontaneous stent passage abdominal x-ray ist used and accordingly retained stents removed. The current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

Conditions

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Pancreatitis Stent Dislodgement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with pancreatic stent

abdominal ultrasound and x-ray for stent detection.

Group Type EXPERIMENTAL

Abdominal ultrasound

Intervention Type DIAGNOSTIC_TEST

Abdominal ultrasound for detection of the pancreatic stent

Interventions

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Abdominal ultrasound

Abdominal ultrasound for detection of the pancreatic stent

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Georg Dultz

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mireen Friedrich-Rust, MD

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Locations

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Klinikum der J.W. Goethe-Universität

Frankfurt am Main, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 33887119 (View on PubMed)

Other Identifiers

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419/17

Identifier Type: -

Identifier Source: org_study_id

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