Complications of Cholecystostomy in ACC (Chole_ACC)

Percutaneous Cholecystostomy, Old-fashioned or There is There Still a Role in ACC?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholecystitis

Detailed Description

It is a single-centre retrospective study of 2000 acute cholecystitis in adults from January 2011 to december 2023, including demographyc characteristics, comorbidy severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines severity classification,the indicatioons for a PC and local complications of PC.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Ana María González Castillo, PhD; Phone Number: +34665126866; Email: amgonzalezcastillo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types of cholecystostomy	There are different indications for cholecystostomy. To do a description of them.	2011-2023
Surgical Rescue	To study the patients that needed a surgical treatment and those who could be operated after recovery from sepsis and descrive the outcomes of all of them within the Clavien-Dindo Classification.	2011-2023

Collaborators and Investigators

• Sponsor: Hospital del Mar
• Investigators: Principal Investigator: Ana María González Castillo, PhD, Hospital Del Mar

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mortality; Tokyo Guidelines; Non-Surgical Treatment; High-risk patient; Acute Choleystitis; Cholecystostomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis
• Other Study ID Numbers: Cholecystostomy in ACC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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