Gallbladder DiseasesNCT03888976
Cholecystoduodenal Fistula With and Without Gallstone Ileus
An observational study of Gallbladder Diseases, run by Tecnologico de Monterrey at 1 site in Mexico.
Trial summary
Observative and descriptive study of 10 patients, which were diagnosed with a Cholecystoduodenal fistula, All electronic medical records were retrospectively reviewed. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Gallbladder Diseases
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2019to 3 Mar 2019
- 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 15 to 100 years
- All sexes
- Child, Adult, Older adult
Study population: Patients who underwent surgical resection of cholecystoduodenal fistula
Who may be able to join
- Patients with cholecystoduodenal fistula
Who cannot join
- Patients with cholecystocolonic fistula or cholecystogastric fistula
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Metropolitano
San Nicolás de los Garza, Nuevo León, 66400
About this study
Official title: 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.
Read the 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.
- Conditions
- Gallbladder Diseases
- Being tested
- Cholecystectomy
- Keywords
- Cholecystoduodenal fistula, Gallbladder
- Medical subject headings
- Gallbladder Diseases, Intestinal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Cholecystectomy with repair of duodenal wall.
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Age
Age in years
Measured: Feb 01- 2020
Median value of white blood count
It will presented in cells/L
Measured: Feb 01-2020
Type of surgery performed
It will described the type of procedure, either conventional or laparoscopic
Measured: Feb 01-2020
Surgical complications
Morbidity will be described as Yes or No
Measured: Feb 01-2020
Recovering time
The median time in days, after the procedure and full recovery of the patients.
Measured: Feb 01-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Feb 2019
- Primary completion26 Feb 2019
- Study completion3 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tecnologico de Monterrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888976
- Sponsor's protocol ID
- CDF031
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not apply
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholecystoduodenal Fistula With and Without Gallstone Ileus: A Case Series
- ClinicalTrials.gov ID
- NCT03888976
- Acronym / sponsor ID
- CDF031
- Conditions
- Gallbladder Diseases
- Keywords
- Cholecystoduodenal fistula, Gallbladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tecnologico de MonterreyUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 3 Mar 2019 (actual)
- First posted
- 25 Mar 2019 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent surgical resection of cholecystoduodenal fistula
Key inclusion criteria (1 listed)
- Patients with cholecystoduodenal fistula
Key exclusion criteria (1 listed)
- Patients with cholecystocolonic fistula or cholecystogastric fistula
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 |
|---|---|---|
| CholecystectomyCholecystectomy with repair of duodenal wall. | Procedure or surgery | – |
Primary outcome
Median Age
Time frame: Feb 01- 2020
Age in years
Median value of white blood count
Time frame: Feb 01-2020
It will presented in cells/L
Type of surgery performed
Time frame: Feb 01-2020
It will described the type of procedure, either conventional or laparoscopic
Surgical complications
Time frame: Feb 01-2020
Morbidity will be described as Yes or No
Recovering time
Time frame: Feb 01-2020
The median time in days, after the procedure and full recovery of the patients.
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 25 Mar 2019.
- Individual participant dataSharing planned: No. not apply
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gallbladder Diseases, run by Tecnologico de Monterrey at 1 site in Mexico.
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 25 Mar 2019. 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 Mexico. 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?
Median Age (time frame: Feb 01- 2020). The study lists 5 primary outcomes in all. 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 25 Mar 2019.