NCT06227936

Brief Summary

Acute cholecystitis (AC) is the second most frequent pathology in Surgical Emergencies; laparoscopic cholecystectomy (LC) is the gold standard treatment, but not all patients are fit for surgery at the diagnostic. Percutaneous Cholecystostomy (PC) is an alternative to LC but has high comorbidity. This study aims to analyse the complications of PC and review its indications in the literature.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

January 18, 2024

Last Update Submit

March 7, 2024

Conditions

Cholecystitis

Keywords

Acute CholeystitisCholecystostomyTokyo GuidelinesNon-Surgical TreatmentMortalityHigh-risk patient

Outcome Measures

Primary Outcomes (2)

  • Complications

    The main outcome measure is the complications due to the PC treatment.

    2011-2023

  • Mortality

    The second main outcome measure is the mortality in patients with an Acute Cholecystitis and its cause.

    2011-2023

Secondary Outcomes (2)

  • Types of cholecystostomy

    2011-2023

  • Surgical Rescue

    2011-2023

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admited with the diagnostic of Acute Cholecystitis from January 2011 to December 2023

You may qualify if:

  • All patients admited in the Hospital del Mar with the diagnostic of an Acute Cholecystitis

You may not qualify if:

  • Acute cholangitis
  • Acute Pancreatitis
  • Neoplasia
  • Chronic Cholecystitis
  • Patients under 18 yearls old
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Ana María González Castillo, PhD

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana María González Castillo, PhD

CONTACT

+34665126866amgonzalezcastillo@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 29, 2024

Study Start

May 15, 2024

Primary Completion

September 1, 2024

Study Completion

September 30, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share