Cholecystoduodenal Fistula With and Without Gallstone Ileus

Cholecystoduodenal Fistula With and Without Gallstone Ileus: A Case Series

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

Study Overview

• Status: Completed
• Conditions: Gallbladder Diseases
• Intervention / Treatment: Procedure: Cholecystectomy

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • San Nicolás De Los Garza, Nuevo Leon, Mexico, 66400
      • Hospital Metropolitano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent surgical resection of cholecystoduodenal fistula

Description

Inclusion Criteria:

• Patients with cholecystoduodenal fistula

Exclusion Criteria:

• Patients with cholecystocolonic fistula or cholecystogastric fistula

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tecnologico de Monterrey

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 26, 2019
• Study Completion (Actual): March 3, 2019

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Gallbladder; Cholecystoduodenal fistula
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Digestive System Fistula; Calculi; Cholelithiasis; Cholecystolithiasis; Fistula; Gallstones; Gallbladder Diseases; Intestinal Fistula
• Other Study ID Numbers: CDF031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: not apply

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No