Biliary Tract DiseasesREQUESTNCT02971579
A Register on the Quality of ERCP and Training of Endoscopists in Italy
An observational study of Biliary Tract Diseases and Pancreatic Diseases, run by ASST Rhodense at 1 site in Italy.
Trial summary
This is a prospective observational longitudinal study Aim of the study is to collect information: on the organization models of the Endoscopic Units performing ERCP in Italy on the previous and/or ongoing training of the endoscopists performing ERCP on the clinical characteristics of patients undergoing ERCP in Italy… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Biliary Tract Diseases, Pancreatic Diseases
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 1,800 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients undergoing ERCP for various indications
Who may be able to join
- Willingness to participate in the study
Who cannot join
- Informed consent not subscribed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Network on the Quality of ERCP, on the Organization of the Endoscopic Units and on the Training of the Endoscopists in Italy
This is a prospective observational longitudinal study
Aim of the study is to collect information:
- on the organization models of the Endoscopic Units performing ERCP in Italy
- on the previous and/or ongoing training of the endoscopists performing ERCP
- on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome
Read the detailed description
Quality of ERCP in Italy has been object of various, mainly retrospective studies in Italy, but it has never systematically and prospectively evaluated in a large prospective series.
Moreover, the study aim at collecting data on the organization models of the Endoscopic Units performing ERCP in Italy; on the previous and/or ongoing training of the endoscopists performing ERCP; on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome of the procedure
The study consists of 3 phases:
- Collection of the information on the Endoscopic Unit and on the endoscopists who performed ERCP in the center
- Collection of data regarding consecutive ERCPs performed in adult patients in each center including demographic, clinical and procedural information
- Definition of the the outcome of ERCP assessed after 30 days from the procedure
- Conditions
- Biliary Tract Diseases, Pancreatic Diseases
- Being tested
- ERCP
- Keywords
- ERCP, biliary diseases, Pancreatic diseases, outcome, Quality, Training
- Medical subject headings
- Biliary Tract Diseases, Pancreatic Diseases, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Endoscopic procedure used to manage biliary and pancreatic diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications rate
Occurrence of post -ERCP complications
Measured: 30 days
Secondary outcomes (1)
Rate of repeated procedure
The rate of ERCPs that have to be repeated within 1 month
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Rhodense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gianpiero manes, ASST Rhodense
- Investigators
- Pietro Occhipinti, MD, Principal investigator, AOU Maggiore della Carità Novara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971579
- Sponsor's protocol ID
- request
- Acronym
- REQUEST
- Status last verified
- Jan 2021
- First submitted
- 20 Nov 2016
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Network on the Quality of ERCP, on the Organization of the Endoscopic Units and on the Training of the Endoscopists in Italy
- ClinicalTrials.gov ID
- NCT02971579
- Acronym / sponsor ID
- REQUEST / request
- Conditions
- Biliary Tract Diseases, Pancreatic Diseases
- Keywords
- ERCP, biliary diseases, Pancreatic diseases, outcome, Quality, Training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- ASST RhodenseUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational longitudinal study
Aim of the study is to collect information:
- on the organization models of the Endoscopic Units performing ERCP in Italy
- on the previous and/or ongoing training of the endoscopists performing ERCP
- on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome
Detailed description
Quality of ERCP in Italy has been object of various, mainly retrospective studies in Italy, but it has never systematically and prospectively evaluated in a large prospective series.
Moreover, the study aim at collecting data on the organization models of the Endoscopic Units performing ERCP in Italy; on the previous and/or ongoing training of the endoscopists performing ERCP; on the clinical characteristics of patients undergoing ERCP in Italy as well as on the outcome of the procedure
The study consists of 3 phases:
- Collection of the information on the Endoscopic Unit and on the endoscopists who performed ERCP in the center
- Collection of data regarding consecutive ERCPs performed in adult patients in each center including demographic, clinical and procedural information
- Definition of the the outcome of ERCP assessed after 30 days from the procedure
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients undergoing ERCP for various indications
Key inclusion criteria (1 listed)
- Willingness to participate in the study
Key exclusion criteria (1 listed)
- Informed consent not subscribed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCPEndoscopic procedure used to manage biliary and pancreatic diseases | Procedure or surgery | – |
Primary outcome
Complications rate
Time frame: 30 days
Occurrence of post -ERCP complications
1 secondary outcome
Rate of repeated procedure
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Occhipinti, MD principal investigator
AOU Maggiore della Carità Novara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Diseases and Pancreatic Diseases, run by ASST Rhodense at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.