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Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP) (QUASIE2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698137
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina

Brief Summary:

The investigators will prospectively collect patient and procedure-related data in an observational study in order to detect patient and procedure-related risk factors for poor outcome (i.e. technical failure of the procedure; procedure-related complications).

Data will be prospectively reported using standard report forms and patients will be followed up to 30 days to detect late-onset complications.


Condition or disease
Cholangiopancreatography, Endoscopic Retrograde Common Bile Duct Lithiasis Biliary Strictures Bile Duct and Pancreatic Tumors

Detailed Description:

This is an investigator-driven, prospective multicenter trial which analyzes the impact of trainee participation on procedure-related outcome (technical success and procedure-related complications).

All ERCPs in the participating centers will be documented using a standard report form which will require the attending endoscopist to provide data relating to the patient (age, gender, diagnosis, bilirubin levels) and the procedure (including but not limited to the indication, technical aspects including cannulation technique, time to cannulation, degree of trainee involvement - where appropriate, procedure-related adverse events and their outcome).

Because teaching ERCP is not yet a standardized procedure, we aim to assemble a large database, stemming from the experience of several teaching centers in order to identify the main patient and operator-related factors which might influence the outcome of the procedure.

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Study Type : Observational
Actual Enrollment : 1843 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Quality Assessment in ERCP: Risk Factors for Procedure-related Complications in Patients Undergoing ERCP in the Setting of an Endoscopy Training Program
Study Start Date : March 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy




Primary Outcome Measures :
  1. procedure-related adverse events [ Time Frame: 30 days ]
    the percentage of patients experiencing procedure-related adverse events (i.e post-ERCP pancreatitis; postERCP cholangitis; perforation; postERCP bleeding or death) occuring within 30 days of the procedure


Secondary Outcome Measures :
  1. technical failure of the procedure [ Time Frame: 30 days ]
    percentage of procedures where the operator was unable to achieve the desired therapeutic goal (i.e selective cannulation, stone removal, stenting)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all consecutive patients undergoing ERCP in an endoscopy training program setting
Criteria

Inclusion Criteria:

  • all patients undergoing ERCP with attempted cannulation of either the major or minor papilla

Exclusion Criteria:

  • refusal to sign the informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698137


Locations
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Croatia
GI Endoscopy Unit, Department of Gastroenterology and Hepatology, University Hospital Zagreb
Zagreb, Croatia, 10000
Italy
Endoscopia Digestiva Chirurgica, Policlinico Gemelli
Roma, Italy
Romania
Gastroenterology Department, Colentina Hospital
Bucharest, Romania, 020125
Sponsors and Collaborators
Clinical Hospital Colentina
Investigators
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Principal Investigator: Theodor Voiosu, MD, PhD Clinical Hospital Colentina
Publications:
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Responsible Party: dr. Theodor Alexandru Voiosu, MD, PhD, Clinical Hospital Colentina
ClinicalTrials.gov Identifier: NCT02698137    
Other Study ID Numbers: QUASIE2
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Lithiasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pathologic Processes