Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis.

December 9, 2021 updated by: Candido Fernando Alcazar-Lopez, Hospital General Universitario de Alicante

Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis: A Retrospective Cohort Study.

Percutaneous cholecystostomy (PC) is an increasingly performed procedure for acute cholecystitis (AC), safe and less invasive than laparoscopic cholecystectomy, very useful in selected patients (severe comorbidities, not suitable for surgery/general anesthesia,..) The investigators conduct a retrospective observational study. Period: 2016-2021. Inclusion criteria: Patients treated with PC for AC. Tokyo guidelines TG13/18 the investigators algorithm to treat AC.

The characteristics of the sample undergoing Percutaneous Cholecystostomy, main indications, evolution and clinical results were reported in an initial observational study. Subsequently, a retrospective analytical study was designed to compare various cohorts: lithiasic vs alithiasic Acute Cholecystitis, elective vs emergency surgery or management with PC alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic cholecystectomy (LC) is the gold standard for the treatment of acute cholecystitis (AC). Percutaneous cholecystostomy (PC) is an increasingly performed procedure for AC, safe and less invasive than LC, very useful in selected patients (severe comorbidities, not suitable for surgery/general anesthesia,..).

The theoretical advantages offered by PC are the rapid resolution of sepsis and the optimal preparation of the patient for elective LC . Its main drawback is the possibility of recurrence of AC or other biliary events while awaiting LC.

Thus, many questions about PC remain unanswered: how should the catheter be handled and removed? When is the best time to perform LC? Should cholecystectomy be offered to all patients after PC? Does PC complicate subsequent cholecystectomy? How good is the adherence to the Tokyo Guidelines in real life? To answer these questions, the investigators devised the present study involving patients undergoing PC at the investigators center.

The inclusion criteria were: patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria. The exclusion criteria were: patients undergoing PC for causes other than AC, such as neoplasms, bile duct alterations or non-therapeutic diagnostic purposes; patients who had previously undergone endoscopic drainage.

The characteristics of the sample undergoing PC, main indications, evolution and clinical results were reported in an initial observational study. Subsequently, a retrospective analytical study was designed to compare various cohorts: lithiasic vs alithiasic AC, elective vs emergency surgery or management with PC alone. Patients' main characteristics, associated morbidity (complications according to Clavien-Dindo grade (CD) and 90-day mortality, need for new drain placement, and surgical approach (laparoscopic vs. open) were compared, following the STROCSS 2019 guidelines.

Variables were compiled from a review of the digitized medical histories which included one year of follow-up. The demographic variables studied were age and sex. Functional status was assessed according to the ASA scale and comorbidity using the Charlson Comorbidity Index (CCI). The type of radiological test used in the diagnosis (ultrasound, computed tomography (CT), nuclear magnetic resonance, cholangioresonance or a combination of these) and laboratory tests (C-reactive protein and leukocyte count) were recorded. Marked local inflammation was defined as gangrenous or emphysematous AC, biliary perforation/peritonitis, or perivesical abscess. Each patient was classified according to the TG13/18 severity scale: Grade I (mild), Grade II (moderate) or Grade III (severe). The degree of adherence to the TG13/18 was taken into account in the indication of PC.

The main indications for PC, total length of hospitalization, time from admission to drainage placement, and drainage duration in days were recorded. The procedure was considered successful when the patient did not require a new drain or emergency surgery, did not die due to the infection, and could be discharged from hospital after PC removal. Even though PC is not a surgical intervention, the Clavien-Dindo complication scale was used.

The patients who underwent cholecystectomy and those placed on the surgical waiting list were recorded, as was the type of surgery (emergency vs elective). In the case of emergency surgery the reason for the intervention was also reported. Approach, conversion rate to open surgery, total length of hospitalization, time from PC to cholecystectomy (in days), and finally complications according to the Clavien-Dindo classification were assessed. Ninety-day mortality rates of patients both after PC and after cholecystectomy were recorded, as well as the causes. As regards clinical evolution, readmission rates for biliary causes (AC, biliary colic, choledocholithiasis, cholangitis and/or pancreatitis) and other causes were reported, along with time until readmission and main reason.

After the general assessment (physical examination, complementary tests and clinical status) the surgical team decided whether to proceed with PC or perform emergency surgery. The PC was placed by interventional radiologists. The technique was performed under local anesthesia in aseptic conditions, guided by ultrasound or CT. Ultrasound-guided transhepatic PC using the Seldinger technique was the usual procedure. Prior to removal, a cholangiography was performed through the catheter in order to check its patency and the passage of the contrast into the duodenum. In some cases, the drain was closed for 24-48 hours to assess tolerance before removal.

Emergency cholecystectomy was performed by the oncall surgical team. If a laparoscopic approach was chosen, it was carried out using the French technique, with dissection of Calot's triangle until the Strasberg critical view of safety was achieved. If an open approach was selected or if conversion from laparoscopic surgery proved necessary, it was carried out via right subcostal laparotomy.

Study Type

Observational

Enrollment (Actual)

195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria

Description

Inclusion Criteria:

  • Patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria

Exclusion Criteria:

  • Patients undergoing PC for causes other than AC, such as neoplasms, bile duct alterations or non-therapeutic diagnostic purposes;
  • Patients who had previously undergone endoscopic drainage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lithiasic acute cholecystitis
Acute cholecystitis with the presence of one or more calculi (gallstones) in the gallbladder.
Other: lithiasic
Cholelithiasis is the presence of one or more calculi (gallstones) in the gallbladder.
alithiasic acute cholecystitis
Acute cholecystitis without the presence of one or more calculi (gallstones) in the gallbladder.
elective cholecystectomy
Elective surgery is surgery that is scheduled in advance because it does not involve a medical emergency.
emergency cholecystectomy
Emergence surgery
Procedure: Emergency surgery
Emergency cholecystectomy
management with percutaneous cholecystostomy alone
Patients that didnt recieve cholecystectomy during de whole study
managemente with surgery
Patients that recieve cholecystectomy during de whole study
Procedure: cholecystectomy
cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
global successful rate
Time Frame: through study completion, an average of 1.5 year
the patient did not require a new drain or emergency surgery, did not die due to the infection, and could be discharged from hospital after PC removal
through study completion, an average of 1.5 year
90-days mortality
Time Frame: 90 days
90 days
complications rate
Time Frame: through study completion, an average of 1.5 year
through study completion, an average of 1.5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
total length of hospitalization during acute episode
Time Frame: through study completion, an average of 1.5 year
through study completion, an average of 1.5 year
drainage duration
Time Frame: through study completion, an average of 1.5 year
through study completion, an average of 1.5 year
1-year readmission rate due to biliary complications
Time Frame: 1 year
1 year
The degree of adherence to treatment algorithm of the Tokyo Guidelines 13/18 in the indication of PC
Time Frame: through study completion, an average of 1.5 year
through study completion, an average of 1.5 year
cholecystectomy rate
Time Frame: through study completion, an average of 1.5 year
through study completion, an average of 1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario de Alicante

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

November 7, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/2021

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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