Treatment of Choledocolithiasis by Laparoscopic Exploration | NCT04690101

Studies
Treatment of Choledocolithiasis by Laparoscopic Exploration

NCT04690101

Sponsor

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Status

Completed

Last Update Posted

Dec 30, 2020Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Choledocholithiasis

Interventions

none, this is an observational study

Countries

Not provided

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

Dec 2020

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

Jan 31, 2009Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Nov 30, 2020Actual

First Submitted Date

Dec 22, 2020

First Submission Date that Met QC Criteria

Dec 27, 2020

First Posted Date

Dec 30, 2020Actual

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

Dec 27, 2020

Last Update Posted Date

Dec 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Israel De Alba Cruz, Principal Investigator, Instituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoPrincipal Investigator

Lead Sponsor

Instituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

There are three treatment options for choledocholithiasis: endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy; laparoscopic exploration of the main bile duct with concomitant cholecystectomy; and open cholecystectomy with exploration of the main bile duct. A retrospective, descriptive, observational study was taken of patients with a diagnosis of cholecystocholedocholithiasis that failed ERCP and who underwent laparoscopic cholecystectomy with exploration of the bile duct.

Detailed Description

this study was revision of clinical files.

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

75Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
none, this is an observational study	Other	none, this is an observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TREATMENT OF CHOLEDOCOLITHIASIS	TREATMENT OF CHOLEDOCOLITHIASIS AFTER FAILED ENDOSCOPIC CHOLANGIOPANCREATOGRAPHY	2009-2018

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service

Exclusion Criteria:

Less than 18 year old

Accepts Healthy Volunteers

Not provided

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 with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service of the General Ignacio Zaragoza

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D042883	Choledocholithiasis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided