Cholecystoduodenal Fistula With and Without Gallstone Ileus | NCT03888976

Studies
Cholecystoduodenal Fistula With and Without Gallstone Ileus

NCT03888976

Sponsor

Tecnologico de Monterrey

Status

Completed

Last Update Posted

Mar 25, 2019Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Gallbladder Diseases

Interventions

Cholecystectomy

Countries

Mexico

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

Mar 2019

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

Feb 1, 2019Actual

Primary Completion Date

Feb 26, 2019Actual

Completion Date

Mar 3, 2019Actual

First Submitted Date

Mar 20, 2019

First Submission Date that Met QC Criteria

Mar 21, 2019

First Posted Date

Mar 25, 2019Actual

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

Mar 21, 2019

Last Update Posted Date

Mar 25, 2019Actual

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

Observative and descriptive study of 10 patients, which were diagnosed with a Cholecystoduodenal fistula, All electronic medical records were retrospectively reviewed.

Detailed Description

A cholecystoenteric fistula is an uncommon complication of gallstone disease, although most studies in the English literature concern biliary-enteric fistulas. The aim of this study was to present a case series of patients with a cholecystoduodenal fistula (CDF), with or without gallstone ileus, along with the surgical outcomes.

From 2015 to 2018, 3245 consecutive patients underwent cholecystectomy for gallbladder disease at our institution, of whom 10 were diagnosed with a CDF. All electronic medical records were retrospectively reviewed.

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

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cholecystectomy	Procedure	Cholecystectomy with repair of duodenal wall.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Median Age	Age in years	Feb 01- 2020
Median value of white blood count	It will presented in cells/L	Feb 01-2020
Type of surgery performed	It will described the type of procedure, either conventional or laparoscopic	Feb 01-2020
Surgical complications	Morbidity will be described as Yes or No	Feb 01-2020
Recovering time	The median time in days, after the procedure and full recovery of the patients.	Feb 01-2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with cholecystoduodenal fistula

Exclusion Criteria:

Patients with cholecystocolonic fistula or cholecystogastric fistula

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who underwent surgical resection of cholecystoduodenal fistula

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Metropolitano		San Nicolás de los Garza	Nuevo León	66400	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

not apply

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005705	Gallbladder Diseases
D007412	Intestinal Fistula

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D016154	Digestive System Fistula
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002763	Cholecystectomy

Ancestor Terms

ID	Term
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided