Influence of the Endoscopists and Endoscopic Retrograde C... | NCT04705740

Studies
Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography

NCT04705740

Sponsor

Fundacion Miguel Servet

Status

Completed

Last Update Posted

Jan 12, 2021Actual

Enrollment

2,561Actual

Phase

Not provided

Conditions

Biliary Disease
Pancreatic Diseases

Interventions

ERCP

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Sep 30, 2020Actual

Completion Date

Oct 31, 2020Actual

First Submitted Date

Dec 11, 2020

First Submission Date that Met QC Criteria

Jan 11, 2021

First Posted Date

Jan 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2021

Last Update Posted Date

Jan 12, 2021Actual

Name	Class
Complejo Hospitalario de Navarra	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retrospective analysis on a prospective database that analyzes the influence of the number of endoscopists on the Endoscopic Retrograde CholangioPanceratography result.

Detailed Description

The number of Endoscopic Retrograde CholangioPanceratographys (ERCP) performed annually by an endoscopist has been shown to influence the outcomes of the procedure, especially on the papillary cannulation rate and the adverse effects rate. The number of ERCPs performed annually by each endoscopist is directly related to the number of endoscopists who perform this procedure, since the total number of ERCPs performed annually at each center is usually constant.

The hypothesis of this study is that the number of endoscopists who perform ERCP in a hospital influences the results of the procedure, so that the fewer the number of endoscopists the better the results.

To evaluate this hypothesis, the investigators have designed a retrospective study analyzing data from a prospectively filled database, which includes all ERCPs performed in our center from September 2013 to June 2020. For organizative reasons unrelated to the endoscopy unit, in the center it has beed progressively reduced the number of endoscopists who perform ERCP, starting from 5 endoscopists at the beginning of the study to 3 endoscopists at the end of the study inclusion period. In fact, three different periods of similar duration can be distinguished: September 2013 to August 2015 (5 endoscopists), September 2015 to December 2017 (4 endoscopists) and January 2018 to June 2020 (3 endoscopists).

The outcomes obtained with ERCP in these three periods will be analyzed and compared, assessing the cannulation rate and the adverse effects rate as the main comparison parameters.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,561Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
September 2013 to August 2015	5 endoscopists	Other: ERCP
September 2015 to December 2017	4 endoscopists	Other: ERCP
January 2018 to June 2020	3 endoscopists	Other: ERCP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ERCP	Other	ERCPs performed annually by an endoscopist	January 2018 to June 2020 September 2013 to August 2015 September 2015 to December 2017

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Papillary cannulation	Rate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically	During the procedure
Adverse effects	Rate of adverse effect assessed by the ASGE classification	Up to 1 month after intervention

Secondary Outcomes

Measure	Description	Time Frame
Individual adverse effects	Rate of individual adverse effect during the intervention	Up to 1 month after intervention
Complexity level of ERCP	Complexity level of ERCP according to ASGE classification of complexity of the endoscopic procedures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing ERCP with written informed consent given
Staff allocated in the endoscopy unit

Exclusion Criteria:

Rejection to participate in the study
ERCP procedures performed by fellows in training

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients over 18 years of age, undergoing ERCP by the staff allocated in the endoscopy unit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juan J Vila, PhD	Complejo Hospitalario de Navarra	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Complejo Hospitalario de Navarra		Pamplona	Navarre	31008	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005705	Gallbladder Diseases
D010182	Pancreatic Diseases
D042883	Choledocholithiasis

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D003137	Common Bile Duct Diseases
D001649	Bile Duct Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002760	Cholangiopancreatography, Endoscopic Retrograde

Ancestor Terms

ID	Term
D002758	Cholangiography
D011860	Radiography, Abdominal
D011859	Radiography
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided